Trial Outcomes & Findings for A Phase II Study of CPC-201 to Treat Alzheimer's Disease Type Dementia (NCT NCT02185053)
NCT ID: NCT02185053
Last Updated: 2020-06-04
Results Overview
Number of participants who reached Donepezil Maximum Tolerated Dose of 40 mg/day (highest allowed per protocol) at the end of donepezil dose titration phase and at the end of the maintenance phase.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
6 months
Results posted on
2020-06-04
Participant Flow
Participant milestones
| Measure |
Solifenacin Dose Escalation
Solifenacin upward dose titration from 10 mg/day to 15 mg/day (together with donepezil 10 mg/day)
|
Donepezil Dose Escalation
Donepezil upward dose titration up to the first intolerable dose (FID) or up to 40 mg/kg together with solifenacin 15 mg/day. End of dose escalation phase.
|
Donepezil Dose Maintenance
Donepezil upward dose titration up to the first intolerable dose (FID) or up to 40 mg/kg together with solifenacin 15 mg/day. End of Dose Maintenance phase.
|
|---|---|---|---|
|
Solifenacin Dose Escalation Phase
STARTED
|
41
|
0
|
0
|
|
Solifenacin Dose Escalation Phase
COMPLETED
|
38
|
0
|
0
|
|
Solifenacin Dose Escalation Phase
NOT COMPLETED
|
3
|
0
|
0
|
|
Donepezil Dose Escalation Phase
STARTED
|
0
|
38
|
0
|
|
Donepezil Dose Escalation Phase
COMPLETED
|
0
|
33
|
0
|
|
Donepezil Dose Escalation Phase
NOT COMPLETED
|
0
|
5
|
0
|
|
Donepezil Dose Maintenance Phase
STARTED
|
0
|
0
|
33
|
|
Donepezil Dose Maintenance Phase
COMPLETED
|
0
|
0
|
30
|
|
Donepezil Dose Maintenance Phase
NOT COMPLETED
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Solifenacin Dose Escalation
Solifenacin upward dose titration from 10 mg/day to 15 mg/day (together with donepezil 10 mg/day)
|
Donepezil Dose Escalation
Donepezil upward dose titration up to the first intolerable dose (FID) or up to 40 mg/kg together with solifenacin 15 mg/day. End of dose escalation phase.
|
Donepezil Dose Maintenance
Donepezil upward dose titration up to the first intolerable dose (FID) or up to 40 mg/kg together with solifenacin 15 mg/day. End of Dose Maintenance phase.
|
|---|---|---|---|
|
Solifenacin Dose Escalation Phase
Cardiac symptoms
|
1
|
0
|
0
|
|
Solifenacin Dose Escalation Phase
No longer meeting eligibility criteria
|
2
|
0
|
0
|
|
Donepezil Dose Escalation Phase
Cardiac symptoms
|
0
|
1
|
0
|
|
Donepezil Dose Escalation Phase
Adverse Event
|
0
|
1
|
0
|
|
Donepezil Dose Escalation Phase
No longer meeting eligibility criteria
|
0
|
2
|
0
|
|
Donepezil Dose Escalation Phase
Withdrawal by Subject
|
0
|
1
|
0
|
|
Donepezil Dose Maintenance Phase
Cardiac symptoms
|
0
|
0
|
1
|
|
Donepezil Dose Maintenance Phase
Withdrawal by Subject
|
0
|
0
|
2
|
Baseline Characteristics
A Phase II Study of CPC-201 to Treat Alzheimer's Disease Type Dementia
Baseline characteristics by cohort
| Measure |
Safety Population
n=41 Participants
All subjects who received at least one dose of any study drug.
|
|---|---|
|
Age, Continuous
|
73.1 Years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsNumber of participants who reached Donepezil Maximum Tolerated Dose of 40 mg/day (highest allowed per protocol) at the end of donepezil dose titration phase and at the end of the maintenance phase.
Outcome measures
| Measure |
Donepezil Dose Escalation
n=33 Participants
Donepezil upward dose titration up to the first intolerable dose (FID) or up to 40 mg/kg together with solifenacin 15 mg/day. End of dose escalation phase.
|
Donepezil Dose Maintenance
n=33 Participants
Donepezil upward dose titration up to the first intolerable dose (FID) or up to 40 mg/kg together with solifenacin 15 mg/day. End of Dose Maintenance phase.
|
Donepezil Dose Maintenance
Donepezil upward dose titration up to the first intolerable dose (FID) or up to 40 mg/kg together with solifenacin 15 mg/day. End of Dose Maintenance phase.
|
|---|---|---|---|
|
Donepezil Maximum Tolerated Dose (MTD)
20 mg/day
|
0 Participants
|
0 Participants
|
—
|
|
Donepezil Maximum Tolerated Dose (MTD)
25 mg/day
|
2 Participants
|
2 Participants
|
—
|
|
Donepezil Maximum Tolerated Dose (MTD)
15 mg/day
|
0 Participants
|
0 Participants
|
—
|
|
Donepezil Maximum Tolerated Dose (MTD)
30 mg/day
|
1 Participants
|
2 Participants
|
—
|
|
Donepezil Maximum Tolerated Dose (MTD)
35 mg/day
|
1 Participants
|
1 Participants
|
—
|
|
Donepezil Maximum Tolerated Dose (MTD)
40 mg/day
|
29 Participants
|
28 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All subjects those who received at least one dose of any study drug.
Number of subjects who experienced any treatment-emergent adverse events (TEAEs) at any time during the study.
Outcome measures
| Measure |
Donepezil Dose Escalation
n=41 Participants
Donepezil upward dose titration up to the first intolerable dose (FID) or up to 40 mg/kg together with solifenacin 15 mg/day. End of dose escalation phase.
|
Donepezil Dose Maintenance
Donepezil upward dose titration up to the first intolerable dose (FID) or up to 40 mg/kg together with solifenacin 15 mg/day. End of Dose Maintenance phase.
|
Donepezil Dose Maintenance
Donepezil upward dose titration up to the first intolerable dose (FID) or up to 40 mg/kg together with solifenacin 15 mg/day. End of Dose Maintenance phase.
|
|---|---|---|---|
|
Number of Subjects With Any TEAEs
Serious Adverse Events (SAEs)
|
8 Participants
|
—
|
—
|
|
Number of Subjects With Any TEAEs
Non-serious AEs
|
34 Participants
|
—
|
—
|
|
Number of Subjects With Any TEAEs
Deaths
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (baseline) to end of studyDonepezil Plasma Concentration pre-dose and 4 hour post-dose at Maximum Tolerated (MTD) or Maximum Allowable Dose, measured at baseline, at end of donepezil dose titration and at the end of maintenance.
Outcome measures
| Measure |
Donepezil Dose Escalation
n=41 Participants
Donepezil upward dose titration up to the first intolerable dose (FID) or up to 40 mg/kg together with solifenacin 15 mg/day. End of dose escalation phase.
|
Donepezil Dose Maintenance
n=32 Participants
Donepezil upward dose titration up to the first intolerable dose (FID) or up to 40 mg/kg together with solifenacin 15 mg/day. End of Dose Maintenance phase.
|
Donepezil Dose Maintenance
n=29 Participants
Donepezil upward dose titration up to the first intolerable dose (FID) or up to 40 mg/kg together with solifenacin 15 mg/day. End of Dose Maintenance phase.
|
|---|---|---|---|
|
Donepezil Plasma Concentration at Maximum Tolerated (MTD) or Maximum Allowable Dose
Donepezil Concentration pre-dose (ng/mL)
|
42.7 ng/mL
Standard Deviation 20.27
|
184.2 ng/mL
Standard Deviation 65.95
|
188.1 ng/mL
Standard Deviation 64.21
|
|
Donepezil Plasma Concentration at Maximum Tolerated (MTD) or Maximum Allowable Dose
Donepezil Concentration 4 hour post-dose (ng/mL)
|
57.2 ng/mL
Standard Deviation 21.58
|
257.5 ng/mL
Standard Deviation 80.56
|
269.2 ng/mL
Standard Deviation 80.94
|
Adverse Events
Safety Population
Serious events: 8 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Safety Population
n=41 participants at risk
All subjects who received at least one dose of any study drug.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.4%
1/41 • Number of events 1
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
Urosepsis
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
Gastric volvulus
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
2.4%
1/41 • Number of events 1
|
|
Nervous system disorders
Syncope
|
2.4%
1/41 • Number of events 2
|
|
Injury, poisoning and procedural complications
Fall
|
2.4%
1/41 • Number of events 1
|
|
Nervous system disorders
Agitation
|
2.4%
1/41 • Number of events 1
|
|
Cardiac disorders
Acute myocardial infarction
|
2.4%
1/41 • Number of events 1
|
Other adverse events
| Measure |
Safety Population
n=41 participants at risk
All subjects who received at least one dose of any study drug.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
17.1%
7/41
|
|
Gastrointestinal disorders
Nausea
|
9.8%
4/41
|
|
Gastrointestinal disorders
Vomiting
|
9.8%
4/41
|
|
Gastrointestinal disorders
Abdominal discomfort
|
9.8%
4/41
|
|
Gastrointestinal disorders
Abdominal pain
|
7.3%
3/41
|
|
Gastrointestinal disorders
Constipation
|
7.3%
3/41
|
|
Injury, poisoning and procedural complications
Fall
|
12.2%
5/41
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.3%
3/41
|
|
Nervous system disorders
Dizziness
|
12.2%
5/41
|
|
Nervous system disorders
Tremor
|
7.3%
3/41
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER