Trial Outcomes & Findings for Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor (NCT NCT02006654)
NCT ID: NCT02006654
Last Updated: 2018-02-07
Results Overview
Change from baseline to Week 24 in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) total score. The Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-cog) is a 11-item neuropsychological test that assess the severity of cognitive impairment. The items determine the patient's orientation, memory, language, and praxis. Total score of the 11 items range from 0 to 70 (lower score indicates lower cognitive impairment).
COMPLETED
PHASE3
734 participants
Baseline and Week 24
2018-02-07
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo adjunct to base treatment with an AChEI
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 60 mg (or 30 mg)
Idalopirdine adjunct to base treatment with an ACHEI
Idalopirdine: Once daily, encapsulated tablets, orally
|
|---|---|---|
|
Overall Study
STARTED
|
369
|
365
|
|
Overall Study
Treated
|
365
|
363
|
|
Overall Study
COMPLETED
|
324
|
321
|
|
Overall Study
NOT COMPLETED
|
45
|
44
|
Reasons for withdrawal
| Measure |
Placebo
Placebo adjunct to base treatment with an AChEI
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 60 mg (or 30 mg)
Idalopirdine adjunct to base treatment with an ACHEI
Idalopirdine: Once daily, encapsulated tablets, orally
|
|---|---|---|
|
Overall Study
Withdrawal before treatment
|
4
|
2
|
|
Overall Study
Adverse Event
|
16
|
17
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
14
|
12
|
|
Overall Study
Protocol Violation
|
5
|
8
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
patient's will
|
2
|
1
|
|
Overall Study
insufficient compliance
|
1
|
0
|
|
Overall Study
worsening cognitive condition
|
0
|
1
|
|
Overall Study
faecal incontinence
|
0
|
1
|
|
Overall Study
mood disorder
|
0
|
1
|
|
Overall Study
disallowed medication
|
1
|
0
|
|
Overall Study
moving out of state
|
0
|
1
|
Baseline Characteristics
Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor
Baseline characteristics by cohort
| Measure |
Placebo
n=365 Participants
Placebo adjunct to base treatment with an AChEI
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 60 mg (or 30 mg)
n=363 Participants
Idalopirdine adjunct to base treatment with an AChEI
Idalopirdine: Once daily, encapsulated tablets, orally
|
Total
n=728 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Region of Enrollment
South Korea
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Age, Continuous
|
74.2 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
73.6 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
73.9 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
131 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
266 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
234 Participants
n=5 Participants
|
228 Participants
n=7 Participants
|
462 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
324 Participants
n=5 Participants
|
324 Participants
n=7 Participants
|
648 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
79 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
292 Participants
n=5 Participants
|
299 Participants
n=7 Participants
|
591 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
42 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
65 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
37 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
MMSE total score at screening
|
17.5 units on a scale
STANDARD_DEVIATION 3.0 • n=5 Participants
|
17.2 units on a scale
STANDARD_DEVIATION 2.9 • n=7 Participants
|
17.3 units on a scale
STANDARD_DEVIATION 2.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.
Change from baseline to Week 24 in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) total score. The Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-cog) is a 11-item neuropsychological test that assess the severity of cognitive impairment. The items determine the patient's orientation, memory, language, and praxis. Total score of the 11 items range from 0 to 70 (lower score indicates lower cognitive impairment).
Outcome measures
| Measure |
Placebo
n=356 Participants
Placebo adjunct to base treatment with an AChEI
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 60 mg (or 30 mg)
n=361 Participants
Idalopirdine adjunct to base treatment with an ACHEI
Idalopirdine: Once daily, encapsulated tablets, orally
|
|---|---|---|
|
Change in Cognition
|
0.68 units on a scale
Standard Error 0.37
|
0.13 units on a scale
Standard Error 0.38
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.
Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score at Week 24. The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change is a semi-structured interview to assess clinically relevant changes in patients with AD. The items determine cognition, behavior, social and daily functioning. Severity at baseline is rated on a 7-point scale from 1 (normal, not ill at all) to 7 (among the most extremely ill patients). The clinically relevant change from baseline is rated on a 7-point scale from 1 (marked improvement) to 7 (marked worsening).
Outcome measures
| Measure |
Placebo
n=353 Participants
Placebo adjunct to base treatment with an AChEI
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 60 mg (or 30 mg)
n=357 Participants
Idalopirdine adjunct to base treatment with an ACHEI
Idalopirdine: Once daily, encapsulated tablets, orally
|
|---|---|---|
|
Change in Global Impression
|
4.32 units on a scale
Standard Error 0.07
|
4.39 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.
Change from baseline to Week 24 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL23) total score. The Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23) is a 23-item clinician-rated inventory to assess activities of daily living (conducted with a caregiver or informant). Each item comprises a series of hierarchical sub-questions, ranging from the highest level of independent performance to a complete loss for each activity. Total score of the 23 items ranges from 0 to 78 (higher score indicates lower disability).
Outcome measures
| Measure |
Placebo
n=356 Participants
Placebo adjunct to base treatment with an AChEI
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 60 mg (or 30 mg)
n=361 Participants
Idalopirdine adjunct to base treatment with an ACHEI
Idalopirdine: Once daily, encapsulated tablets, orally
|
|---|---|---|
|
Change in Daily Functioning
|
-1.72 units on a scale
Standard Error 0.50
|
-1.05 units on a scale
Standard Error 0.51
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.
Change from baseline to Week 24 in Neuropsychiatric Inventory (NPI) total score The Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is then rated for frequency (a 4-point scale from 1 \[occasionally\] to 4 \[very frequent\]) and severity (a 3-point scale from 1 \[mild\] to 3 \[marked\]). The total NPI score is the frequency ratings multiplied by the severity ratings and ranges from 0 to 144 (higher score indicates worse outcome).
Outcome measures
| Measure |
Placebo
n=356 Participants
Placebo adjunct to base treatment with an AChEI
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 60 mg (or 30 mg)
n=361 Participants
Idalopirdine adjunct to base treatment with an ACHEI
Idalopirdine: Once daily, encapsulated tablets, orally
|
|---|---|---|
|
Change in Behavioural Disturbance
|
-0.46 units on a scale
Standard Error 0.53
|
-0.74 units on a scale
Standard Error 0.54
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: All patients who took at least one dose of placebo or idalopirdine and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure/item assessed
Change in single NPI item scores at Week 24. The Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is then rated for frequency (a 4-point scale from 1 \[occasionally\] to 4 \[very frequent\]) and severity (a 3-point scale from 1 \[mild\] to 3 \[marked\]). Total score for each single NPI item ranges from 0-12 (frequency multiplied by severity), where higher scores represent worse outcome.
Outcome measures
| Measure |
Placebo
n=356 Participants
Placebo adjunct to base treatment with an AChEI
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 60 mg (or 30 mg)
n=361 Participants
Idalopirdine adjunct to base treatment with an ACHEI
Idalopirdine: Once daily, encapsulated tablets, orally
|
|---|---|---|
|
Change in Individual Behavioural Disturbance Items
Delusions
|
-0.00 units on a scale
Standard Error 0.10
|
0.03 units on a scale
Standard Error 0.10
|
|
Change in Individual Behavioural Disturbance Items
Hallucinations
|
0.05 units on a scale
Standard Error 0.06
|
0.08 units on a scale
Standard Error 0.06
|
|
Change in Individual Behavioural Disturbance Items
Agitation/aggression
|
0.15 units on a scale
Standard Error 0.11
|
0.03 units on a scale
Standard Error 0.11
|
|
Change in Individual Behavioural Disturbance Items
Depression/dysphoria
|
-0.28 units on a scale
Standard Error 0.09
|
-0.18 units on a scale
Standard Error 0.09
|
|
Change in Individual Behavioural Disturbance Items
Anxiety
|
-0.16 units on a scale
Standard Error 0.09
|
-0.07 units on a scale
Standard Error 0.09
|
|
Change in Individual Behavioural Disturbance Items
Elation/euphoria
|
0.02 units on a scale
Standard Error 0.04
|
0.03 units on a scale
Standard Error 0.04
|
|
Change in Individual Behavioural Disturbance Items
Apathy/indifference
|
-0.06 units on a scale
Standard Error 0.15
|
-0.19 units on a scale
Standard Error 0.15
|
|
Change in Individual Behavioural Disturbance Items
Disinhibition
|
0.12 units on a scale
Standard Error 0.08
|
-0.00 units on a scale
Standard Error 0.08
|
|
Change in Individual Behavioural Disturbance Items
Irritability/lability
|
0.10 units on a scale
Standard Error 0.12
|
-0.04 units on a scale
Standard Error 0.12
|
|
Change in Individual Behavioural Disturbance Items
Aberrant motor behaviour
|
0.08 units on a scale
Standard Error 0.11
|
0.11 units on a scale
Standard Error 0.11
|
|
Change in Individual Behavioural Disturbance Items
Sleep
|
-0.13 units on a scale
Standard Error 0.11
|
-0.12 units on a scale
Standard Error 0.11
|
|
Change in Individual Behavioural Disturbance Items
Appetite/eating disorder
|
-0.25 units on a scale
Standard Error 0.12
|
-0.21 units on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: All patients who took at least one dose of placebo or idalopirdine and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome/item measure assessed
Change from baseline to Week 24 in NPI anxiety item score in patients with an NPI anxiety item score of at least 2 at baseline The Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is then rated for frequency (a 4-point scale from 1 \[occasionally\] to 4 \[very frequent\]) and severity (a 3-point scale from 1 \[mild\] to 3 \[marked\]). The total score for the NPI anxiety item ranges from 0-12 (frequency multiplied by severity), where a higher score represents a worse outcome.
Outcome measures
| Measure |
Placebo
n=86 Participants
Placebo adjunct to base treatment with an AChEI
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 60 mg (or 30 mg)
n=83 Participants
Idalopirdine adjunct to base treatment with an ACHEI
Idalopirdine: Once daily, encapsulated tablets, orally
|
|---|---|---|
|
Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline
|
-1.93 units on a scale
Standard Error 0.32
|
-1.52 units on a scale
Standard Error 0.33
|
SECONDARY outcome
Timeframe: Week 24Population: All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.
Clinical response at Week 24 (based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes \[change in ADAS-cog below or equal to -4, change in ADCS-ADL23 at least 0, and ADCS-CGIC below or equal to 4\])
Outcome measures
| Measure |
Placebo
n=324 Participants
Placebo adjunct to base treatment with an AChEI
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 60 mg (or 30 mg)
n=321 Participants
Idalopirdine adjunct to base treatment with an ACHEI
Idalopirdine: Once daily, encapsulated tablets, orally
|
|---|---|---|
|
Clinical Improvement
|
32 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.
Clinical worsening at Week 24 (Based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes \[change in ADAS-cog above or equal to 4, change in ADCS-ADL23 below 0, and ADCS-CGIC above 4\])
Outcome measures
| Measure |
Placebo
n=324 Participants
Placebo adjunct to base treatment with an AChEI
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 60 mg (or 30 mg)
n=321 Participants
Idalopirdine adjunct to base treatment with an ACHEI
Idalopirdine: Once daily, encapsulated tablets, orally
|
|---|---|---|
|
Clinical Worsening
|
37 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.
Change from baseline to Week 24 in Mini Mental State Examination (MMSE). The Mini Mental State Examination (MMSE) is an 11-item test to assess the cognitive aspects of mental function. The subtests assess orientation, memory, attention, language, and visual construction. The scores for each item is dichotomous (1 = response is correct, 0 = response is incorrect). Total score of the 11 items ranges from 0 to 30 (higher score indicates lower deficit).
Outcome measures
| Measure |
Placebo
n=323 Participants
Placebo adjunct to base treatment with an AChEI
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 60 mg (or 30 mg)
n=320 Participants
Idalopirdine adjunct to base treatment with an ACHEI
Idalopirdine: Once daily, encapsulated tablets, orally
|
|---|---|---|
|
Change in Cognitive Aspects of Mental Function
|
-0.64 units on a scale
Standard Error 0.20
|
-0.35 units on a scale
Standard Error 0.20
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.
Change from baseline to Week 24 in EuroQol 5-dimensional (EQ-5D) utility score The EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). Each descriptive item is rated on a 3-point index ranging from 1 (no problems) to 3 (extreme problems) that is used for calculating a single summary index (from 0 to 1). A higher EQ-5D score indicates a worse outcome.
Outcome measures
| Measure |
Placebo
n=351 Participants
Placebo adjunct to base treatment with an AChEI
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 60 mg (or 30 mg)
n=354 Participants
Idalopirdine adjunct to base treatment with an ACHEI
Idalopirdine: Once daily, encapsulated tablets, orally
|
|---|---|---|
|
Change in Health-related Quality of Life (EQ-5D) Utility Score
|
-0.01 units on a scale
Standard Error 0.01
|
-0.00 units on a scale
Standard Error 0.01
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.
Change from baseline to Week 24 in EQ-5D Visual Analogue Scale (EQ-5D VAS). The EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Outcome measures
| Measure |
Placebo
n=351 Participants
Placebo adjunct to base treatment with an AChEI
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 60 mg (or 30 mg)
n=353 Participants
Idalopirdine adjunct to base treatment with an ACHEI
Idalopirdine: Once daily, encapsulated tablets, orally
|
|---|---|---|
|
Change in Health-related Quality of Life (EQ-5D VAS)
|
-0.40 units on a scale
Standard Error 1.00
|
0.51 units on a scale
Standard Error 1.02
|
Adverse Events
Placebo
Idalopirdine 60 mg
Serious adverse events
| Measure |
Placebo
n=365 participants at risk
Placebo adjunct to base treatment with an AChEI
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 60 mg
n=363 participants at risk
Idalopirdine adjunct to base treatment with an AChEI
Idalopirdine: Once daily, encapsulated tablets, orally
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.00%
0/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.55%
2/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.28%
1/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Cardiac disorders
Myocardial infarction
|
0.55%
2/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.28%
1/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Eye disorders
Retinal detachment
|
0.00%
0/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.28%
1/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.28%
1/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.27%
1/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.28%
1/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.28%
1/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.28%
1/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
General disorders
Chest pain
|
0.00%
0/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.28%
1/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.28%
1/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.28%
1/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Diverticulitis
|
0.27%
1/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Erysipelas
|
0.27%
1/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.28%
1/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.28%
1/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.27%
1/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.28%
1/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.28%
1/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.27%
1/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.28%
1/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Fall
|
0.27%
1/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
1.4%
5/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.28%
1/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.28%
1/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Head injury
|
0.27%
1/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.28%
1/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Laceration
|
0.55%
2/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.55%
2/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.27%
1/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.27%
1/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.27%
1/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.27%
1/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.27%
1/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Investigations
Electrocardiogram st segment depression
|
0.27%
1/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.28%
1/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.27%
1/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.27%
1/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.28%
1/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/234 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.44%
1/228 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.00%
0/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.28%
1/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Cerebral haematoma
|
0.27%
1/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.27%
1/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Dizziness
|
0.27%
1/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.27%
1/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Intracranial haematoma
|
0.27%
1/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Ischaemic stroke
|
0.27%
1/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Lethargy
|
0.00%
0/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.28%
1/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.28%
1/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.28%
1/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Syncope
|
0.27%
1/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.28%
1/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Agitation
|
0.27%
1/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Behavioural and psychiatric symptoms of dementia
|
0.00%
0/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.28%
1/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Personality disorder
|
0.27%
1/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Renal and urinary disorders
Azotaemia
|
0.27%
1/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.27%
1/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Vascular disorders
Hypertension
|
0.55%
2/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.28%
1/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Vascular disorders
Internal haemorrhage
|
0.00%
0/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.28%
1/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Vascular disorders
Peripheral vascular disorder
|
0.27%
1/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
0.28%
1/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
Other adverse events
| Measure |
Placebo
n=365 participants at risk
Placebo adjunct to base treatment with an AChEI
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 60 mg
n=363 participants at risk
Idalopirdine adjunct to base treatment with an AChEI
Idalopirdine: Once daily, encapsulated tablets, orally
|
|---|---|---|
|
Injury, poisoning and procedural complications
Accidental overdose
|
11.8%
43/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
11.0%
40/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Fall
|
5.8%
21/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
5.2%
19/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Investigations
Aspartate aminotransferase increased
|
0.82%
3/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
5.2%
19/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.55%
2/365 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
6.1%
22/363 • Baseline to end of study
Treatment-Emergent Adverse Events are reported in this section
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place