Trial Outcomes & Findings for Efficacy and Safety of MK-1167 in Participants With Alzheimer's Disease Dementia Taking Stable Donepezil Treatment (MK-1167-007) (NCT NCT06285240)
NCT ID: NCT06285240
Last Updated: 2025-10-14
Results Overview
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE were reported.
COMPLETED
PHASE1
28 participants
Up to approximately 7 weeks
2025-10-14
Participant Flow
All randomized participants
Participant milestones
| Measure |
Panel A: MK-1167 + Donepezil 10mg QD
Participants received 6mg MK-1167 oral loading doses once daily (QD) Days 1 to 7, followed by 3mg MK-1167 oral maintenance doses QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD + Donepezil 10mg QD
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also received 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days-3 to 31.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
4
|
9
|
3
|
|
Overall Study
Treated
|
12
|
4
|
9
|
3
|
|
Overall Study
Panel A Participants Who Received 6mg of MK-1167
|
12
|
0
|
0
|
0
|
|
Overall Study
Panel A Participants Who Received 3mg of MK-1167
|
12
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
10
|
4
|
8
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Panel A: MK-1167 + Donepezil 10mg QD
Participants received 6mg MK-1167 oral loading doses once daily (QD) Days 1 to 7, followed by 3mg MK-1167 oral maintenance doses QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD + Donepezil 10mg QD
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also received 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days-3 to 31.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
|
Overall Study
Serious Adverse Event
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of MK-1167 in Participants With Alzheimer's Disease Dementia Taking Stable Donepezil Treatment (MK-1167-007)
Baseline characteristics by cohort
| Measure |
Panel A: MK-1167 + Donepezil 10mg QD
n=12 Participants
Participants received 6mg MK-1167 oral loading doses once daily (QD) Days 1 to 7, followed by 3mg MK-1167 oral maintenance doses QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
n=4 Participants
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD + Donepezil 10mg QD
n=9 Participants
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also received 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
n=3 Participants
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days-3 to 31.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
68.2 Years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
63.5 Years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
69.9 Years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
75.3 Years
STANDARD_DEVIATION 2.9 • n=4 Participants
|
68.8 Years
STANDARD_DEVIATION 8.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 7 weeksPopulation: All randomized participants who received at least one dose of study treatment.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE were reported.
Outcome measures
| Measure |
Panel A: MK-1167 6mg QD + Donepezil 10mg QD
n=12 Participants
Participants received 6mg MK-1167 oral loading doses QD Days 1 to 7. Participants also receive 10mg oral Donepezil on Days -3 to 21.
|
Panel A: MK-1167 3mg QD + Donepezil 10mg QD
n=12 Participants
After an oral loading dose of 6mg MK-1167, participants received oral maintenance dose of 3mg MK-1167 QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
n=4 Participants
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD+ Donepezil 10mg QD
n=9 Participants
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
n=3 Participants
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days -3 to 31.
|
|---|---|---|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
3 Participants
|
5 Participants
|
2 Participants
|
6 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 4 weeksPopulation: All randomized participants who received at least one dose of study treatment.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE were reported.
Outcome measures
| Measure |
Panel A: MK-1167 6mg QD + Donepezil 10mg QD
n=12 Participants
Participants received 6mg MK-1167 oral loading doses QD Days 1 to 7. Participants also receive 10mg oral Donepezil on Days -3 to 21.
|
Panel A: MK-1167 3mg QD + Donepezil 10mg QD
n=12 Participants
After an oral loading dose of 6mg MK-1167, participants received oral maintenance dose of 3mg MK-1167 QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
n=4 Participants
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD+ Donepezil 10mg QD
n=9 Participants
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
n=3 Participants
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days -3 to 31.
|
|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to an AE
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdosePopulation: All Panel A randomized participants who received at least one dose of study treatment (6mg of MK-1167) and had at least one postdose data available for assessment.
AUC0-24 was defined as the area under the concentration-time curve of MK-1167 from time zero to 24 hours. Blood samples were collected at pre-specified intervals for the determination of AUC0-24. Per protocol, AUC0-24 was based on noncompartmental analysis, and a geometric mean AUC0-24 value was presented for Panel A participants after administration of 6mg of MK-1167.
Outcome measures
| Measure |
Panel A: MK-1167 6mg QD + Donepezil 10mg QD
n=10 Participants
Participants received 6mg MK-1167 oral loading doses QD Days 1 to 7. Participants also receive 10mg oral Donepezil on Days -3 to 21.
|
Panel A: MK-1167 3mg QD + Donepezil 10mg QD
After an oral loading dose of 6mg MK-1167, participants received oral maintenance dose of 3mg MK-1167 QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD+ Donepezil 10mg QD
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days -3 to 31.
|
|---|---|---|---|---|---|
|
Panel A: Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24) After Administration of 6mg of MK-1167
|
2.17 μM*hour
Interval 1.22 to 3.84
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 8, 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdosePopulation: All Panel A randomized participants who received at least one dose of study treatment (3mg of MK-1167) and had at least one postdose data available for assessment.
AUC0-24 was defined as the area under the concentration-time curve of MK-1167 from time zero to 24 hours. Blood samples were collected at pre-specified intervals for the determination of AUC0-24. Per protocol, AUC0-24 was based on noncompartmental analysis, and a geometric mean AUC 0-24 value was presented for Panel A participants after administration of 3mg of MK-1167.
Outcome measures
| Measure |
Panel A: MK-1167 6mg QD + Donepezil 10mg QD
n=12 Participants
Participants received 6mg MK-1167 oral loading doses QD Days 1 to 7. Participants also receive 10mg oral Donepezil on Days -3 to 21.
|
Panel A: MK-1167 3mg QD + Donepezil 10mg QD
After an oral loading dose of 6mg MK-1167, participants received oral maintenance dose of 3mg MK-1167 QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD+ Donepezil 10mg QD
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days -3 to 31.
|
|---|---|---|---|---|---|
|
Panel A: AUC0-24 After Administration of 3mg of MK-1167
Day 8
|
8.70 μM*hour
Interval 4.95 to 15.3
|
—
|
—
|
—
|
—
|
|
Panel A: AUC0-24 After Administration of 3mg of MK-1167
Day 21
|
8.08 μM*hour
Interval 4.56 to 14.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 23, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdosePopulation: All Panel B randomized participants who received at least one dose of study treatment (6mg of MK-1167) and had at least one postdose data available for assessment.
AUC0-24 was defined as the area under the concentration-time curve of MK-1167 from time zero to 24 hours. Blood samples were collected at pre-specified intervals for the determination of AUC0-24. Per protocol, AUC0-24 was based on noncompartmental analysis, and a geometric mean AUC0-24 value was presented for Panel B participants after administration of 6mg of MK-1167.
Outcome measures
| Measure |
Panel A: MK-1167 6mg QD + Donepezil 10mg QD
n=9 Participants
Participants received 6mg MK-1167 oral loading doses QD Days 1 to 7. Participants also receive 10mg oral Donepezil on Days -3 to 21.
|
Panel A: MK-1167 3mg QD + Donepezil 10mg QD
After an oral loading dose of 6mg MK-1167, participants received oral maintenance dose of 3mg MK-1167 QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD+ Donepezil 10mg QD
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days -3 to 31.
|
|---|---|---|---|---|---|
|
Panel B: AUC0-24 After Administration of 6mg of MK-1167
Day 1
|
2.48 μM*hour
Interval 2.04 to 3.01
|
—
|
—
|
—
|
—
|
|
Panel B: AUC0-24 After Administration of 6mg of MK-1167
Day 23
|
22.2 μM*hour
Interval 18.1 to 27.1
|
—
|
—
|
—
|
—
|
|
Panel B: AUC0-24 After Administration of 6mg of MK-1167
Day 31
|
22.9 μM*hour
Interval 18.8 to 28.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdosePopulation: All Panel A randomized participants who received at least one dose of study treatment (6mg of MK-1167) and had at least one postdose data available for assessment.
Cmax was defined as the maximum serum concentration of MK-1167 reached. Blood samples were collected at pre-specified timepoints for the determination of Cmax. Per protocol, Cmax was based on noncompartmental analysis, and a geometric mean Cmax value was presented for Panel A participants after administration of 6mg of MK-1167.
Outcome measures
| Measure |
Panel A: MK-1167 6mg QD + Donepezil 10mg QD
n=10 Participants
Participants received 6mg MK-1167 oral loading doses QD Days 1 to 7. Participants also receive 10mg oral Donepezil on Days -3 to 21.
|
Panel A: MK-1167 3mg QD + Donepezil 10mg QD
After an oral loading dose of 6mg MK-1167, participants received oral maintenance dose of 3mg MK-1167 QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD+ Donepezil 10mg QD
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days -3 to 31.
|
|---|---|---|---|---|---|
|
Panel A: Maximum Plasma Concentration (Cmax) After Administration of 6mg of MK-1167
|
0.129 μmol/Liter
Interval 0.0731 to 0.228
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 8, 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdosePopulation: All Panel A randomized participants who received at least one dose of study treatment (3mg of MK-1167) and had at least one postdose data available for assessment.
Cmax was defined as the maximum serum concentration of MK-1167 reached. Blood samples were collected at pre-specified timepoints for the determination of Cmax. Per protocol, Cmax was based on noncompartmental analysis, and a geometric mean Cmax value was presented for Panel A participants after administration of 3mg of MK-1167.
Outcome measures
| Measure |
Panel A: MK-1167 6mg QD + Donepezil 10mg QD
n=12 Participants
Participants received 6mg MK-1167 oral loading doses QD Days 1 to 7. Participants also receive 10mg oral Donepezil on Days -3 to 21.
|
Panel A: MK-1167 3mg QD + Donepezil 10mg QD
After an oral loading dose of 6mg MK-1167, participants received oral maintenance dose of 3mg MK-1167 QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD+ Donepezil 10mg QD
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days -3 to 31.
|
|---|---|---|---|---|---|
|
Panel A: Cmax After Administration of 3mg of MK-1167
Day 8
|
0.434 μmol/Liter
Interval 0.247 to 0.761
|
—
|
—
|
—
|
—
|
|
Panel A: Cmax After Administration of 3mg of MK-1167
Day 21
|
0.413 μmol/Liter
Interval 0.234 to 0.729
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 23, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdosePopulation: All Panel B randomized participants who received at least one dose of study treatment (6mg of MK-1167) and had at least one postdose data available for assessment.
Cmax was defined as the maximum serum concentration of MK-1167 reached. Blood samples were collected at pre-specified timepoints for the determination of Cmax. Per protocol, Cmax was based on noncompartmental analysis, and a geometric mean Cmax value was presented for Panel B participants after administration of 6mg of MK-1167.
Outcome measures
| Measure |
Panel A: MK-1167 6mg QD + Donepezil 10mg QD
n=9 Participants
Participants received 6mg MK-1167 oral loading doses QD Days 1 to 7. Participants also receive 10mg oral Donepezil on Days -3 to 21.
|
Panel A: MK-1167 3mg QD + Donepezil 10mg QD
After an oral loading dose of 6mg MK-1167, participants received oral maintenance dose of 3mg MK-1167 QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD+ Donepezil 10mg QD
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days -3 to 31.
|
|---|---|---|---|---|---|
|
Panel B: Cmax After Administration of 6mg of MK-1167
Day 1
|
0.145 μmol/Liter
Interval 0.121 to 0.174
|
—
|
—
|
—
|
—
|
|
Panel B: Cmax After Administration of 6mg of MK-1167
Day 23
|
1.11 μmol/Liter
Interval 0.919 to 1.35
|
—
|
—
|
—
|
—
|
|
Panel B: Cmax After Administration of 6mg of MK-1167
Day 31
|
1.14 μmol/Liter
Interval 0.941 to 1.38
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdosePopulation: All Panel A randomized participants who received at least one dose of study treatment (6mg of MK-1167) and had at least one postdose data available for assessment.
C24 was defined as the serum concentration of MK-1167 reached at 24 hours. Blood samples were collected at pre-specified timepoints for the determination of C24. Per protocol, C24 was based on noncompartmental analysis, and a geometric mean C24 value was presented for Panel A participants after administration of 6mg of MK-1167.
Outcome measures
| Measure |
Panel A: MK-1167 6mg QD + Donepezil 10mg QD
n=10 Participants
Participants received 6mg MK-1167 oral loading doses QD Days 1 to 7. Participants also receive 10mg oral Donepezil on Days -3 to 21.
|
Panel A: MK-1167 3mg QD + Donepezil 10mg QD
After an oral loading dose of 6mg MK-1167, participants received oral maintenance dose of 3mg MK-1167 QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD+ Donepezil 10mg QD
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days -3 to 31.
|
|---|---|---|---|---|---|
|
Panel A: Plasma Concentration at 24 Hours (C24) After Administration of 6mg of MK-1167
|
0.0902 μmol/Liter
Interval 0.05 to 0.163
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 8, 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdosePopulation: All Panel A randomized participants who received at least one dose of study treatment (3mg MK-1167) and had at least one postdose data available for assessment.
C24 was defined as the serum concentration of MK-1167 reached at 24 hours. Blood samples were collected at pre-specified timepoints for the determination of C24. Per protocol, C24 was based on noncompartmental analysis, and a geometric mean C24 value was presented for Panel A participants after administration of 3mg of MK-1167.
Outcome measures
| Measure |
Panel A: MK-1167 6mg QD + Donepezil 10mg QD
n=12 Participants
Participants received 6mg MK-1167 oral loading doses QD Days 1 to 7. Participants also receive 10mg oral Donepezil on Days -3 to 21.
|
Panel A: MK-1167 3mg QD + Donepezil 10mg QD
After an oral loading dose of 6mg MK-1167, participants received oral maintenance dose of 3mg MK-1167 QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD+ Donepezil 10mg QD
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days -3 to 31.
|
|---|---|---|---|---|---|
|
Panel A: C24 After Administration of 3mg of MK-1167
Day 8
|
0.362 μmol/Liter
Interval 0.203 to 0.647
|
—
|
—
|
—
|
—
|
|
Panel A: C24 After Administration of 3mg of MK-1167
Day 21
|
0.313 μmol/Liter
Interval 0.174 to 0.565
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 23, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdosePopulation: All Panel B randomized participants who received at least one dose of study treatment (6mg of MK-1167) and had at least one postdose data available for assessment.
C24 was defined as the serum concentration of MK-1167 reached at 24 hours. Blood samples were collected at pre-specified timepoints for the determination of C24. Per protocol, C24 was based on noncompartmental analysis, and a geometric mean C24 value was presented for Panel B participants after administration of 6mg of MK-1167.
Outcome measures
| Measure |
Panel A: MK-1167 6mg QD + Donepezil 10mg QD
n=9 Participants
Participants received 6mg MK-1167 oral loading doses QD Days 1 to 7. Participants also receive 10mg oral Donepezil on Days -3 to 21.
|
Panel A: MK-1167 3mg QD + Donepezil 10mg QD
After an oral loading dose of 6mg MK-1167, participants received oral maintenance dose of 3mg MK-1167 QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD+ Donepezil 10mg QD
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days -3 to 31.
|
|---|---|---|---|---|---|
|
Panel B: C24 After Administration of 6mg of MK-1167
Day 1
|
0.0917 μmol/Liter
Interval 0.0731 to 0.115
|
—
|
—
|
—
|
—
|
|
Panel B: C24 After Administration of 6mg of MK-1167
Day 23
|
0.729 μmol/Liter
Interval 0.576 to 0.922
|
—
|
—
|
—
|
—
|
|
Panel B: C24 After Administration of 6mg of MK-1167
Day 31
|
0.875 μmol/Liter
Interval 0.691 to 1.11
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdosePopulation: All Panel A randomized participants who received at least one dose of study treatment (6mg of MK-1167) and had at least one postdose data available for assessment.
Tmax was defined as time to the maximum concentration of MK-1167 reached. Blood samples were collected at pre-specified intervals for the determination of Tmax. Per protocol, Tmax was based on noncompartmental analysis, and a median Tmax value was presented for Panel A participants after administration of 6mg of MK-1167.
Outcome measures
| Measure |
Panel A: MK-1167 6mg QD + Donepezil 10mg QD
n=10 Participants
Participants received 6mg MK-1167 oral loading doses QD Days 1 to 7. Participants also receive 10mg oral Donepezil on Days -3 to 21.
|
Panel A: MK-1167 3mg QD + Donepezil 10mg QD
After an oral loading dose of 6mg MK-1167, participants received oral maintenance dose of 3mg MK-1167 QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD+ Donepezil 10mg QD
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days -3 to 31.
|
|---|---|---|---|---|---|
|
Panel A: Time to Maximum Plasma Concentration (Tmax) After Administration of 6mg of MK-1167
|
1.54 hours
Interval 0.5 to 8.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 8, 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdosePopulation: All Panel A randomized participants who received at least one dose of study treatment (3mg of MK-1167) and had at least one postdose data available for assessment.
Tmax was defined as time to the maximum concentration of MK-1167 reached. Blood samples were collected at pre-specified intervals for the determination of Tmax. Per protocol, Tmax was based on noncompartmental analysis, and a median Tmax value was presented for Panel A participants after administration of 3mg of MK-1167.
Outcome measures
| Measure |
Panel A: MK-1167 6mg QD + Donepezil 10mg QD
n=12 Participants
Participants received 6mg MK-1167 oral loading doses QD Days 1 to 7. Participants also receive 10mg oral Donepezil on Days -3 to 21.
|
Panel A: MK-1167 3mg QD + Donepezil 10mg QD
After an oral loading dose of 6mg MK-1167, participants received oral maintenance dose of 3mg MK-1167 QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD+ Donepezil 10mg QD
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days -3 to 31.
|
|---|---|---|---|---|---|
|
Panel A: Tmax After Administration of 3mg of MK-1167
Day 8
|
6.00 hours
Interval 0.0 to 23.97
|
—
|
—
|
—
|
—
|
|
Panel A: Tmax After Administration of 3mg of MK-1167
Day 21
|
4.01 hours
Interval 1.22 to 11.92
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 23, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdosePopulation: All Panel B randomized participants who received at least one dose of study treatment (6mg of MK-1167) and had at least one postdose data available for assessment.
Tmax was defined as time to the maximum concentration of MK-1167 reached. Blood samples were collected at pre-specified intervals for the determination of Tmax. Per protocol, Tmax was based on noncompartmental analysis, and a median Tmax value was presented for Panel B participants after administration of 6mg of MK-1167.
Outcome measures
| Measure |
Panel A: MK-1167 6mg QD + Donepezil 10mg QD
n=9 Participants
Participants received 6mg MK-1167 oral loading doses QD Days 1 to 7. Participants also receive 10mg oral Donepezil on Days -3 to 21.
|
Panel A: MK-1167 3mg QD + Donepezil 10mg QD
After an oral loading dose of 6mg MK-1167, participants received oral maintenance dose of 3mg MK-1167 QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD+ Donepezil 10mg QD
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days -3 to 31.
|
|---|---|---|---|---|---|
|
Panel B: Tmax After Administration of 6mg of MK-1167
Day 1
|
1.08 hours
Interval 0.48 to 5.78
|
—
|
—
|
—
|
—
|
|
Panel B: Tmax After Administration of 6mg of MK-1167
Day 23
|
4.03 hours
Interval 0.58 to 11.92
|
—
|
—
|
—
|
—
|
|
Panel B: Tmax After Administration of 6mg of MK-1167
Day 31
|
2.97 hours
Interval 0.42 to 11.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdosePopulation: All Panel A randomized participants who received at least one dose of study treatment (3mg of MK-1167) and had at least one postdose data available for assessment.
CL/F is the rate at which the MK-1167 is completely removed from plasma. Blood samples were collected at pre-specified intervals for the determination of CL/F. Per protocol, CL/F was based on noncompartmental analysis, and a geometric mean CL/F value was presented for Panel A participants after administration of 3mg of MK-1167.
Outcome measures
| Measure |
Panel A: MK-1167 6mg QD + Donepezil 10mg QD
n=10 Participants
Participants received 6mg MK-1167 oral loading doses QD Days 1 to 7. Participants also receive 10mg oral Donepezil on Days -3 to 21.
|
Panel A: MK-1167 3mg QD + Donepezil 10mg QD
After an oral loading dose of 6mg MK-1167, participants received oral maintenance dose of 3mg MK-1167 QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD+ Donepezil 10mg QD
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days -3 to 31.
|
|---|---|---|---|---|---|
|
Panel A: Apparent Clearance (CL/F) After Administration of 3mg of MK-1167
|
0.879 Liter/hour
Geometric Coefficient of Variation 166.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdosePopulation: All Panel B randomized participants who received at least one dose of study treatment (6mg of MK-1167) and had at least one postdose data available for assessment.
CL/F is the rate at which the MK-1167 is completely removed from plasma. Blood samples were collected at pre-specified intervals for the determination of CL/F. Per protocol, CL/F was based on noncompartmental analysis, and a geometric mean CL/F value was presented for Panel B participants after administration of 6mg of MK-1167.
Outcome measures
| Measure |
Panel A: MK-1167 6mg QD + Donepezil 10mg QD
n=8 Participants
Participants received 6mg MK-1167 oral loading doses QD Days 1 to 7. Participants also receive 10mg oral Donepezil on Days -3 to 21.
|
Panel A: MK-1167 3mg QD + Donepezil 10mg QD
After an oral loading dose of 6mg MK-1167, participants received oral maintenance dose of 3mg MK-1167 QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD+ Donepezil 10mg QD
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days -3 to 31.
|
|---|---|---|---|---|---|
|
Panel B: CL/F After Administration of 6mg of MK-1167
|
0.606 Liter/hour
Geometric Coefficient of Variation 32.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdosePopulation: All Panel A randomized participants who received at least one dose of study treatment (3mg of MK-1167) and had at least one postdose data available for assessment.
t1/2 is defined as the time required to divide plasma concentration of MK-1167 by half after reaching pseudo-equilibrium. Blood samples were collected at pre-specified intervals for the determination of t1/2. Per protocol, t1/2 was based on noncompartmental analysis, and a geometric mean t1/2 value was presented for Panel A participants after administration of 3mg of MK-1167.
Outcome measures
| Measure |
Panel A: MK-1167 6mg QD + Donepezil 10mg QD
n=10 Participants
Participants received 6mg MK-1167 oral loading doses QD Days 1 to 7. Participants also receive 10mg oral Donepezil on Days -3 to 21.
|
Panel A: MK-1167 3mg QD + Donepezil 10mg QD
After an oral loading dose of 6mg MK-1167, participants received oral maintenance dose of 3mg MK-1167 QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD+ Donepezil 10mg QD
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days -3 to 31.
|
|---|---|---|---|---|---|
|
Panel A: Apparent Terminal Half-Life (t1/2) After Administration of 3mg of MK-1167
|
194 hours
Geometric Coefficient of Variation 48.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdosePopulation: All Panel B randomized participants who received at least one dose of study treatment (6mg of MK-1167) and had at least one postdose data available for assessment.
t1/2 was defined as the time required to divide plasma concentration of MK-1167 by half after reaching pseudo-equilibrium. Blood samples were collected at pre-specified timepoints for the determination of t1/2. Per protocol, t1/2 was based on noncompartmental analysis, and a geometric mean t1/2 value was presented for Panel B participants after administration of 6mg of MK-1167.
Outcome measures
| Measure |
Panel A: MK-1167 6mg QD + Donepezil 10mg QD
n=8 Participants
Participants received 6mg MK-1167 oral loading doses QD Days 1 to 7. Participants also receive 10mg oral Donepezil on Days -3 to 21.
|
Panel A: MK-1167 3mg QD + Donepezil 10mg QD
After an oral loading dose of 6mg MK-1167, participants received oral maintenance dose of 3mg MK-1167 QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD+ Donepezil 10mg QD
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days -3 to 31.
|
|---|---|---|---|---|---|
|
Panel B: t1/2 After Administration of 6mg of MK-1167
|
193 hour
Geometric Coefficient of Variation 40.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdosePopulation: All Panel A randomized participants who received at least one dose of study treatment (3mg of MK-1167) and had at least one postdose data available for assessment.
Vz/F was the apparent volume of distribution of MK-1167. Blood samples were collected at pre-specified intervals for the determination of Vz/F. Per protocol, Vz/F was based on noncompartmental analysis, and a geometric mean Vz/F value was presented for Panel A participants after administration of 3mg of MK-1167.
Outcome measures
| Measure |
Panel A: MK-1167 6mg QD + Donepezil 10mg QD
n=10 Participants
Participants received 6mg MK-1167 oral loading doses QD Days 1 to 7. Participants also receive 10mg oral Donepezil on Days -3 to 21.
|
Panel A: MK-1167 3mg QD + Donepezil 10mg QD
After an oral loading dose of 6mg MK-1167, participants received oral maintenance dose of 3mg MK-1167 QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD+ Donepezil 10mg QD
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days -3 to 31.
|
|---|---|---|---|---|---|
|
Panel A: Apparent Volume of Distribution (Vz/F) After Administration of 3mg of MK-1167
|
246 Liter
Geometric Coefficient of Variation 166.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdosePopulation: All Panel B randomized participants who received at least one dose of study treatment (6mg of MK-1167) and had at least one postdose data available for assessment.
Vz/F was the apparent volume of distribution of MK-1167. Blood samples were collected at pre-specified intervals for the determination of Vz/F. Per protocol, Vz/F was based on noncompartmental analysis, and a geometric mean Vz/F value was presented for Panel B participants after administration of 6mg of MK-1167.
Outcome measures
| Measure |
Panel A: MK-1167 6mg QD + Donepezil 10mg QD
n=8 Participants
Participants received 6mg MK-1167 oral loading doses QD Days 1 to 7. Participants also receive 10mg oral Donepezil on Days -3 to 21.
|
Panel A: MK-1167 3mg QD + Donepezil 10mg QD
After an oral loading dose of 6mg MK-1167, participants received oral maintenance dose of 3mg MK-1167 QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD+ Donepezil 10mg QD
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days -3 to 31.
|
|---|---|---|---|---|---|
|
Panel B: Vz/F After Administration of 6mg of MK-1167
|
169 Liter
Geometric Coefficient of Variation 19.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 23: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdosePopulation: All Panel B randomized participants who received at least one dose of study treatment and had AUC0-24 data available for assessment on Day 1 and Day 23.
Blood samples were collected at pre-specified timepoints to determine AUC0-24 on Days 1 and 23. AUC0-24 was defined as the area under the concentration-time curve of MK-1167 from time zero to 24 hours. Accumulation ratio of MK-1167 Day 23 to Day 1 was calculated as Day 23 AUC0-24/Day 1 AUC0-24.
Outcome measures
| Measure |
Panel A: MK-1167 6mg QD + Donepezil 10mg QD
n=8 Participants
Participants received 6mg MK-1167 oral loading doses QD Days 1 to 7. Participants also receive 10mg oral Donepezil on Days -3 to 21.
|
Panel A: MK-1167 3mg QD + Donepezil 10mg QD
After an oral loading dose of 6mg MK-1167, participants received oral maintenance dose of 3mg MK-1167 QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD+ Donepezil 10mg QD
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days -3 to 31.
|
|---|---|---|---|---|---|
|
Panel B: Day 23 to Day 1 Accumulation Ratio of AUC0-24 After Administration of 6mg of MK-1167
|
8.95 Ratio
Interval 7.8 to 10.27
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdosePopulation: All Panel B randomized participants who received at least one dose of study treatment and had AUC0-24 data available for assessment on Day 1 and Day 31.
Blood samples were collected at pre-specified timepoints to determine AUC0-24 on Days 1 and 31. AUC0-24 was defined as the area under the concentration-time curve of MK-1167 from time zero to 24 hours. Accumulation ratio of MK-1167 Day 31 to Day 1 was calculated as Day 31 AUC0-24/Day 1 AUC0-24.
Outcome measures
| Measure |
Panel A: MK-1167 6mg QD + Donepezil 10mg QD
n=8 Participants
Participants received 6mg MK-1167 oral loading doses QD Days 1 to 7. Participants also receive 10mg oral Donepezil on Days -3 to 21.
|
Panel A: MK-1167 3mg QD + Donepezil 10mg QD
After an oral loading dose of 6mg MK-1167, participants received oral maintenance dose of 3mg MK-1167 QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD+ Donepezil 10mg QD
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days -3 to 31.
|
|---|---|---|---|---|---|
|
Panel B: Day 31 to Day 1 Accumulation Ratio of AUC0-24 After Administration of 6mg of MK-1167
|
9.26 Ratio
Interval 8.08 to 10.62
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 23: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdosePopulation: All Panel B randomized participants who received at least one dose of study treatment and had at Cmax data available for assessment on Day 1 and Day 23.
Blood samples were collected at pre-specified timepoints to determine Cmax on Days 1 and 23. Cmax was defined as the maximum serum concentration of MK-1167 reached. Accumulation ratio of MK-1167 Day 23 to Day 1 was calculated as Day 23 Cmax/Day 1 Cmax.
Outcome measures
| Measure |
Panel A: MK-1167 6mg QD + Donepezil 10mg QD
n=8 Participants
Participants received 6mg MK-1167 oral loading doses QD Days 1 to 7. Participants also receive 10mg oral Donepezil on Days -3 to 21.
|
Panel A: MK-1167 3mg QD + Donepezil 10mg QD
After an oral loading dose of 6mg MK-1167, participants received oral maintenance dose of 3mg MK-1167 QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD+ Donepezil 10mg QD
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days -3 to 31.
|
|---|---|---|---|---|---|
|
Panel B: Day 23 to Day 1 Accumulation Ratio of Cmax After Administration of 6mg of MK-1167
|
7.69 Ratio
Interval 6.46 to 9.16
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdosePopulation: All Panel B randomized participants who received at least one dose of study treatment and had at Cmax data available for assessment on Day 1 and Day 31.
Blood samples were collected at pre-specified timepoints to determine Cmax on Days 1 and 31. Cmax was defined as the maximum serum concentration of MK-1167 reached. Accumulation ratio of MK-1167 Day 31 to Day 1 was calculated as Day 31 Cmax/Day 1 Cmax.
Outcome measures
| Measure |
Panel A: MK-1167 6mg QD + Donepezil 10mg QD
n=8 Participants
Participants received 6mg MK-1167 oral loading doses QD Days 1 to 7. Participants also receive 10mg oral Donepezil on Days -3 to 21.
|
Panel A: MK-1167 3mg QD + Donepezil 10mg QD
After an oral loading dose of 6mg MK-1167, participants received oral maintenance dose of 3mg MK-1167 QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD+ Donepezil 10mg QD
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days -3 to 31.
|
|---|---|---|---|---|---|
|
Panel B: Day 31 to Day 1 Accumulation Ratio of Cmax After Administration of 6mg of MK-1167
|
7.88 Ratio
Interval 6.62 to 9.38
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 23: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdosePopulation: All Panel B randomized participants who received at least one dose of study treatment and had C24 data available for assessment on Day 1 and Day 23.
Blood samples were collected at pre-specified timepoints to determine C24 on Days 1 and 23. C24 was defined as the serum concentration of MK-1167 reached at 24 hours. Blood samples were collected at pre-specified timepoints for the determination of C24. Accumulation ratio of MK-1167 Day 23 to Day 1 was calculated as Day 23 C24/Day 1 C24.
Outcome measures
| Measure |
Panel A: MK-1167 6mg QD + Donepezil 10mg QD
n=8 Participants
Participants received 6mg MK-1167 oral loading doses QD Days 1 to 7. Participants also receive 10mg oral Donepezil on Days -3 to 21.
|
Panel A: MK-1167 3mg QD + Donepezil 10mg QD
After an oral loading dose of 6mg MK-1167, participants received oral maintenance dose of 3mg MK-1167 QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD+ Donepezil 10mg QD
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days -3 to 31.
|
|---|---|---|---|---|---|
|
Panel B: Day 23 to Day 1 Accumulation Ratio of C24 After Administration of 6mg of MK-1167
|
7.94 Ratio
Interval 6.64 to 9.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdosePopulation: All Panel B randomized participants who received at least one dose of study treatment and had C24 data available for assessment on Day 1 and Day 31.
Blood samples were collected at pre-specified timepoints to determine C24 on Days 1 and 31. C24 was defined as the serum concentration of MK-1167 reached at 24 hours. Blood samples were collected at pre-specified timepoints for the determination of C24. Accumulation ratio of MK-1167 Day 31 to Day 1 was calculated as Day 31 C24/Day 1 C24.
Outcome measures
| Measure |
Panel A: MK-1167 6mg QD + Donepezil 10mg QD
n=8 Participants
Participants received 6mg MK-1167 oral loading doses QD Days 1 to 7. Participants also receive 10mg oral Donepezil on Days -3 to 21.
|
Panel A: MK-1167 3mg QD + Donepezil 10mg QD
After an oral loading dose of 6mg MK-1167, participants received oral maintenance dose of 3mg MK-1167 QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD+ Donepezil 10mg QD
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days -3 to 31.
|
|---|---|---|---|---|---|
|
Panel B: Day 31 to Day 1 Accumulation Ratio of C24 After Administration of 6mg of MK-1167
|
9.54 Ratio
Interval 7.97 to 11.4
|
—
|
—
|
—
|
—
|
Adverse Events
Panel A: MK-1167 6mg QD + Donepezil 10mg QD
Panel A: MK-1167 3mg QD + Donepezil 10mg QD
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
Panel B: MK-1167 6mg QD + Donepezil 10mg QD
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
Serious adverse events
| Measure |
Panel A: MK-1167 6mg QD + Donepezil 10mg QD
n=12 participants at risk
Participants received 6mg MK-1167 oral loading doses QD Days 1to 7. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: MK-1167 3mg QD + Donepezil 10mg QD
n=12 participants at risk
After an oral loading dose of 6mg MK-1167, participants received oral maintenance dose of 3mg MK-1167 QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
n=4 participants at risk
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD + Donepezil 10mg QD
n=9 participants at risk
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also received 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
n=3 participants at risk
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days-3 to 31.
|
|---|---|---|---|---|---|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/4 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
11.1%
1/9 • Number of events 1 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/3 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
Other adverse events
| Measure |
Panel A: MK-1167 6mg QD + Donepezil 10mg QD
n=12 participants at risk
Participants received 6mg MK-1167 oral loading doses QD Days 1to 7. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: MK-1167 3mg QD + Donepezil 10mg QD
n=12 participants at risk
After an oral loading dose of 6mg MK-1167, participants received oral maintenance dose of 3mg MK-1167 QD Days 8 to 21. Participants also received 10mg oral Donepezil on Days -3 to 21.
|
Panel A: Placebo to MK-1167 + Donepezil 10mg QD
n=4 participants at risk
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also received 10mg oral Donepezil QD on Days-3 to 21.
|
Panel B: MK-1167 6mg QD + Donepezil 10mg QD
n=9 participants at risk
Participants received 6mg MK-1167 oral doses QD Days 1 to 31. Participants also received 10mg oral Donepezil on Days -3 to 31.
|
Panel B: Placebo to MK-1167 + Donepezil 10mg QD
n=3 participants at risk
Participants received dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also received 10mg oral Donepezil QD on Days-3 to 31.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
8.3%
1/12 • Number of events 1 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/4 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/9 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/3 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/4 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
11.1%
1/9 • Number of events 1 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/3 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/4 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
11.1%
1/9 • Number of events 1 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/3 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
2/12 • Number of events 2 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/4 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/9 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/3 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/4 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
11.1%
1/9 • Number of events 1 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/3 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/4 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
11.1%
1/9 • Number of events 1 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/3 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 1 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/4 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/9 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/3 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
|
General disorders
Chills
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/4 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
11.1%
1/9 • Number of events 1 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/3 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
|
General disorders
Malaise
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/4 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
11.1%
1/9 • Number of events 1 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/3 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
|
General disorders
Pyrexia
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/4 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
11.1%
1/9 • Number of events 1 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/3 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
8.3%
1/12 • Number of events 1 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/4 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/9 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/3 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/4 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
22.2%
2/9 • Number of events 2 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/3 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
|
Investigations
Electrocardiogram PR prolongation
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
8.3%
1/12 • Number of events 1 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/4 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/9 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/3 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
8.3%
1/12 • Number of events 1 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/4 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/9 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/3 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/4 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
11.1%
1/9 • Number of events 1 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/3 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/4 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
11.1%
1/9 • Number of events 1 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/3 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
25.0%
1/4 • Number of events 1 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
11.1%
1/9 • Number of events 1 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/3 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
8.3%
1/12 • Number of events 1 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/4 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/9 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/3 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
|
Nervous system disorders
Tremor
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/4 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
11.1%
1/9 • Number of events 1 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/3 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/4 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
11.1%
1/9 • Number of events 1 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/3 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
25.0%
1/4 • Number of events 1 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/9 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/3 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/4 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
11.1%
1/9 • Number of events 1 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/3 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/4 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
11.1%
1/9 • Number of events 1 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/3 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
25.0%
1/4 • Number of events 1 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/9 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/3 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
|
Vascular disorders
Hypertension
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/4 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
11.1%
1/9 • Number of events 1 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/3 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • Number of events 1 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/4 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/9 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/3 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
25.0%
1/4 • Number of events 1 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/9 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/3 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
|
Vascular disorders
Pallor
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/12 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
25.0%
1/4 • Number of events 1 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/9 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
0.00%
0/3 • Up to approximately 25 weeks
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, Panel A: Placebo to MK-1167 + Donepezil 10mg QD arm was reported combined as dose matched placebo.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Results disclosure agreements
- Principal investigator is a sponsor employee The results of this study may be published or presented at scientific meetings. The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. Any information identified by the Sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER