Trial Outcomes & Findings for Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil (NCT NCT01955161)
NCT ID: NCT01955161
Last Updated: 2017-09-19
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
933 participants
Baseline to Week 24
2017-09-19
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo adjunct to 10 mg Donepezil
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 30 mg
Idalopirdine adjunct to 10 mg Donepezil
Idalopirdine: Once daily, encapsulated tablets, orally
|
Idalopirdine 60 mg
Idalopirdine adjunct to 10 mg Donepezil
Idalopirdine: Once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
Overall Study
STARTED
|
310
|
313
|
310
|
|
Overall Study
Treated
|
308
|
313
|
309
|
|
Overall Study
COMPLETED
|
283
|
288
|
275
|
|
Overall Study
NOT COMPLETED
|
27
|
25
|
35
|
Reasons for withdrawal
| Measure |
Placebo
Placebo adjunct to 10 mg Donepezil
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 30 mg
Idalopirdine adjunct to 10 mg Donepezil
Idalopirdine: Once daily, encapsulated tablets, orally
|
Idalopirdine 60 mg
Idalopirdine adjunct to 10 mg Donepezil
Idalopirdine: Once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
Overall Study
Withdrawal before treatment
|
2
|
0
|
1
|
|
Overall Study
Adverse Event
|
10
|
14
|
15
|
|
Overall Study
Death
|
1
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
9
|
8
|
12
|
|
Overall Study
Protocol Violation
|
2
|
0
|
0
|
|
Overall Study
Other reason: physician decision
|
0
|
1
|
1
|
|
Overall Study
Other reason: disallowed medication
|
1
|
0
|
1
|
|
Overall Study
Other reason: caregiver unavailable
|
1
|
0
|
0
|
|
Overall Study
Other reason: moved to nursing home
|
0
|
1
|
0
|
|
Overall Study
Other reason: insufficient compliance
|
0
|
0
|
1
|
|
Overall Study
Other reason: primary biliary cirrhosis
|
1
|
0
|
0
|
|
Overall Study
Other reason: patient's will
|
0
|
0
|
1
|
Baseline Characteristics
Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil
Baseline characteristics by cohort
| Measure |
Placebo
n=308 Participants
Placebo adjunct to 10 mg Donepezil
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 30 mg
n=313 Participants
Idalopirdine adjunct to 10 mg Donepezil
Idalopirdine: Once daily, encapsulated tablets, orally
|
Idalopirdine 60 mg
n=309 Participants
Idalopirdine adjunct to 10 mg Donepezil
Idalopirdine: Once daily, encapsulated tablets, orally
|
Total
n=930 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
73.8 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
74.0 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
73.7 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
73.8 years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
198 Participants
n=5 Participants
|
208 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
607 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
323 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
125 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
266 Participants
n=5 Participants
|
268 Participants
n=7 Participants
|
267 Participants
n=5 Participants
|
801 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
283 Participants
n=5 Participants
|
287 Participants
n=7 Participants
|
284 Participants
n=5 Participants
|
854 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Region of Enrollment
Argentina
|
24 participants
n=5 Participants
|
25 participants
n=7 Participants
|
21 participants
n=5 Participants
|
70 participants
n=4 Participants
|
|
Region of Enrollment
Romania
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Region of Enrollment
Czech Republic
|
36 participants
n=5 Participants
|
35 participants
n=7 Participants
|
38 participants
n=5 Participants
|
109 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
45 participants
n=7 Participants
|
43 participants
n=5 Participants
|
130 participants
n=4 Participants
|
|
Region of Enrollment
Ukraine
|
21 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
61 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
19 participants
n=5 Participants
|
22 participants
n=7 Participants
|
19 participants
n=5 Participants
|
60 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
15 participants
n=5 Participants
|
12 participants
n=7 Participants
|
13 participants
n=5 Participants
|
40 participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
5 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Region of Enrollment
Denmark
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
25 participants
n=5 Participants
|
24 participants
n=7 Participants
|
24 participants
n=5 Participants
|
73 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
11 participants
n=5 Participants
|
36 participants
n=4 Participants
|
|
Region of Enrollment
South Africa
|
18 participants
n=5 Participants
|
19 participants
n=7 Participants
|
20 participants
n=5 Participants
|
57 participants
n=4 Participants
|
|
Region of Enrollment
Bulgaria
|
22 participants
n=5 Participants
|
19 participants
n=7 Participants
|
19 participants
n=5 Participants
|
60 participants
n=4 Participants
|
|
Region of Enrollment
Chile
|
28 participants
n=5 Participants
|
30 participants
n=7 Participants
|
31 participants
n=5 Participants
|
89 participants
n=4 Participants
|
|
Region of Enrollment
France
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
17 participants
n=5 Participants
|
46 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
17 participants
n=5 Participants
|
22 participants
n=7 Participants
|
19 participants
n=5 Participants
|
58 participants
n=4 Participants
|
|
MMSE total score at screening
|
17.4 units on a scale
STANDARD_DEVIATION 2.9 • n=5 Participants
|
17.2 units on a scale
STANDARD_DEVIATION 3.1 • n=7 Participants
|
17.4 units on a scale
STANDARD_DEVIATION 2.9 • n=5 Participants
|
17.4 units on a scale
STANDARD_DEVIATION 3.0 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on 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=304 Participants
Placebo adjunct to 10 mg Donepezil
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 30 mg
n=310 Participants
Idalopirdine adjunct to 10 mg Donepezil
Idalopirdine: Once daily, encapsulated tablets, orally
|
Idalopirdine 60 mg
n=308 Participants
Idalopirdine adjunct to 10 mg Donepezil
Idalopirdine: Once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
Change in Cognition
|
0.13 units on a scale
Standard Error 0.35
|
0.47 units on a scale
Standard Error 0.35
|
0.18 units on a scale
Standard Error 0.35
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on 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=304 Participants
Placebo adjunct to 10 mg Donepezil
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 30 mg
n=310 Participants
Idalopirdine adjunct to 10 mg Donepezil
Idalopirdine: Once daily, encapsulated tablets, orally
|
Idalopirdine 60 mg
n=308 Participants
Idalopirdine adjunct to 10 mg Donepezil
Idalopirdine: Once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
Change in Daily Functioning
|
-2.03 units on a scale
Standard Error 0.49
|
-2.12 units on a scale
Standard Error 0.48
|
-2.02 units on a scale
Standard Error 0.49
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on 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=303 Participants
Placebo adjunct to 10 mg Donepezil
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 30 mg
n=309 Participants
Idalopirdine adjunct to 10 mg Donepezil
Idalopirdine: Once daily, encapsulated tablets, orally
|
Idalopirdine 60 mg
n=307 Participants
Idalopirdine adjunct to 10 mg Donepezil
Idalopirdine: Once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
Change in Global Impression
|
4.29 units on a scale
Standard Error 0.07
|
4.32 units on a scale
Standard Error 0.07
|
4.13 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on 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 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=304 Participants
Placebo adjunct to 10 mg Donepezil
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 30 mg
n=310 Participants
Idalopirdine adjunct to 10 mg Donepezil
Idalopirdine: Once daily, encapsulated tablets, orally
|
Idalopirdine 60 mg
n=308 Participants
Idalopirdine adjunct to 10 mg Donepezil
Idalopirdine: Once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
Change in Behavioural Disturbance
|
-0.21 units on a scale
Standard Error 0.62
|
-0.21 units on a scale
Standard Error 0.62
|
-0.39 units on a scale
Standard Error 0.63
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on 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=304 Participants
Placebo adjunct to 10 mg Donepezil
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 30 mg
n=310 Participants
Idalopirdine adjunct to 10 mg Donepezil
Idalopirdine: Once daily, encapsulated tablets, orally
|
Idalopirdine 60 mg
n=308 Participants
Idalopirdine adjunct to 10 mg Donepezil
Idalopirdine: Once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
Change in Individual Behavioural Disturbance Items
Apathy/indifference
|
-0.18 units on a scale
Standard Error 0.15
|
-0.23 units on a scale
Standard Error 0.15
|
-0.27 units on a scale
Standard Error 0.15
|
|
Change in Individual Behavioural Disturbance Items
Disinhibition
|
0.05 units on a scale
Standard Error 0.08
|
-0.06 units on a scale
Standard Error 0.08
|
-0.01 units on a scale
Standard Error 0.08
|
|
Change in Individual Behavioural Disturbance Items
Irritability/lability
|
-0.14 units on a scale
Standard Error 0.12
|
0.02 units on a scale
Standard Error 0.12
|
0.00 units on a scale
Standard Error 0.12
|
|
Change in Individual Behavioural Disturbance Items
Aberrant motor behaviour
|
0.03 units on a scale
Standard Error 0.12
|
0.33 units on a scale
Standard Error 0.12
|
-0.13 units on a scale
Standard Error 0.13
|
|
Change in Individual Behavioural Disturbance Items
Sleep
|
0.03 units on a scale
Standard Error 0.11
|
0.01 units on a scale
Standard Error 0.11
|
0.03 units on a scale
Standard Error 0.11
|
|
Change in Individual Behavioural Disturbance Items
Appetite/eating disorder
|
-0.08 units on a scale
Standard Error 0.13
|
-0.14 units on a scale
Standard Error 0.13
|
-0.04 units on a scale
Standard Error 0.13
|
|
Change in Individual Behavioural Disturbance Items
Depression/dysphoria
|
0.02 units on a scale
Standard Error 0.09
|
-0.06 units on a scale
Standard Error 0.09
|
-0.08 units on a scale
Standard Error 0.10
|
|
Change in Individual Behavioural Disturbance Items
Hallucinations
|
0.13 units on a scale
Standard Error 0.07
|
0.03 units on a scale
Standard Error 0.07
|
-0.03 units on a scale
Standard Error 0.07
|
|
Change in Individual Behavioural Disturbance Items
Agitation/aggression
|
0.01 units on a scale
Standard Error 0.11
|
0.04 units on a scale
Standard Error 0.11
|
0.10 units on a scale
Standard Error 0.11
|
|
Change in Individual Behavioural Disturbance Items
Delusions
|
-0.11 units on a scale
Standard Error 0.09
|
-0.04 units on a scale
Standard Error 0.09
|
-0.01 units on a scale
Standard Error 0.09
|
|
Change in Individual Behavioural Disturbance Items
Anxiety
|
-0.02 units on a scale
Standard Error 0.11
|
-0.13 units on a scale
Standard Error 0.11
|
-0.13 units on a scale
Standard Error 0.11
|
|
Change in Individual Behavioural Disturbance Items
Elation/euphoria
|
0.09 units on a scale
Standard Error 0.05
|
0.03 units on a scale
Standard Error 0.05
|
0.03 units on a scale
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on 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=88 Participants
Placebo adjunct to 10 mg Donepezil
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 30 mg
n=83 Participants
Idalopirdine adjunct to 10 mg Donepezil
Idalopirdine: Once daily, encapsulated tablets, orally
|
Idalopirdine 60 mg
n=76 Participants
Idalopirdine adjunct to 10 mg Donepezil
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
|
-1.12 units on a scale
Standard Error 0.30
|
-1.56 units on a scale
Standard Error 0.30
|
-1.64 units on a scale
Standard Error 0.32
|
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 on 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=284 Participants
Placebo adjunct to 10 mg Donepezil
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 30 mg
n=290 Participants
Idalopirdine adjunct to 10 mg Donepezil
Idalopirdine: Once daily, encapsulated tablets, orally
|
Idalopirdine 60 mg
n=278 Participants
Idalopirdine adjunct to 10 mg Donepezil
Idalopirdine: Once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
Clinical Improvement
|
34 Participants
|
37 Participants
|
27 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 on 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=284 Participants
Placebo adjunct to 10 mg Donepezil
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 30 mg
n=290 Participants
Idalopirdine adjunct to 10 mg Donepezil
Idalopirdine: Once daily, encapsulated tablets, orally
|
Idalopirdine 60 mg
n=278 Participants
Idalopirdine adjunct to 10 mg Donepezil
Idalopirdine: Once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
Clinical Worsening
|
40 Participants
|
42 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on 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=282 Participants
Placebo adjunct to 10 mg Donepezil
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 30 mg
n=288 Participants
Idalopirdine adjunct to 10 mg Donepezil
Idalopirdine: Once daily, encapsulated tablets, orally
|
Idalopirdine 60 mg
n=274 Participants
Idalopirdine adjunct to 10 mg Donepezil
Idalopirdine: Once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
Change in Cognitive Aspects of Mental Function
|
0.06 units on a scale
Standard Error 0.16
|
-0.27 units on a scale
Standard Error 0.16
|
0.27 units on a scale
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on 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=301 Participants
Placebo adjunct to 10 mg Donepezil
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 30 mg
n=306 Participants
Idalopirdine adjunct to 10 mg Donepezil
Idalopirdine: Once daily, encapsulated tablets, orally
|
Idalopirdine 60 mg
n=304 Participants
Idalopirdine adjunct to 10 mg Donepezil
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
|
0.00 units on a scale
Standard Error 0.01
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on 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=301 Participants
Placebo adjunct to 10 mg Donepezil
Placebo: Once daily, matching placebo capsules, orally
|
Idalopirdine 30 mg
n=307 Participants
Idalopirdine adjunct to 10 mg Donepezil
Idalopirdine: Once daily, encapsulated tablets, orally
|
Idalopirdine 60 mg
n=304 Participants
Idalopirdine adjunct to 10 mg Donepezil
Idalopirdine: Once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
Change in Health-related Quality of Life (EQ-5D VAS)
|
-0.40 units on a scale
Standard Error 1.01
|
-0.12 units on a scale
Standard Error 1.01
|
0.34 units on a scale
Standard Error 1.03
|
Adverse Events
Placebo
Idalopirdine 30 mg
Idalopirdine 60 mg
Serious adverse events
| Measure |
Placebo
n=308 participants at risk
Placebo adjunct to 10 mg Donepezil
|
Idalopirdine 30 mg
n=313 participants at risk
Idalopirdine adjunct to 10 mg Donezepil
|
Idalopirdine 60 mg
n=309 participants at risk
Idalopirdine adjunct to 10 mg Donezepil
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.32%
1/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Cardiac disorders
Atrial fibrillation
|
0.32%
1/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.32%
1/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.32%
1/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
General disorders
Sudden death
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Appendicitis
|
0.32%
1/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Bacterial diarrhoea
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Influenza
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Pneumonia
|
0.32%
1/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Pneumonia bacterial
|
0.65%
2/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.32%
1/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.32%
1/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Investigations
Alanine aminotransferase increased
|
0.32%
1/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Investigations
Aspartate aminotransferase increased
|
0.32%
1/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Investigations
Bilirubin conjugated increased
|
0.32%
1/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Investigations
Blood alkaline phosphatase increased
|
0.32%
1/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Investigations
Blood bilirubin increased
|
0.32%
1/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Investigations
C-reactive protein increased
|
0.32%
1/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.32%
1/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.65%
2/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Dementia alzheimer's type
|
0.32%
1/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Presyncope
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Syncope
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Transient ischaemic attack
|
0.32%
1/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Confusional state
|
0.32%
1/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Delirium
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Impulse-control disorder
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/198 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/208 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.50%
1/201 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Reproductive system and breast disorders
Vaginal fistula
|
0.51%
1/198 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/208 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/201 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Surgical and medical procedures
Colostomy closure
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Surgical and medical procedures
Rehabilitation therapy
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.65%
2/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Vascular disorders
Hypotension
|
0.32%
1/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.32%
1/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
Other adverse events
| Measure |
Placebo
n=308 participants at risk
Placebo adjunct to 10 mg Donepezil
|
Idalopirdine 30 mg
n=313 participants at risk
Idalopirdine adjunct to 10 mg Donezepil
|
Idalopirdine 60 mg
n=309 participants at risk
Idalopirdine adjunct to 10 mg Donezepil
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Accidental overdose
|
8.8%
27/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
8.6%
27/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
5.2%
16/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Fall
|
4.9%
15/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
5.1%
16/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
6.1%
19/309 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.32%
1/308 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
5.4%
17/313 • Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
|
4.9%
15/309 • Baseline to end of study at Week 24
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