Trial Outcomes & Findings for SUVN-502 With Donepezil and Memantine for the Treatment of Moderate Alzheimer's Disease- Phase 2a Study (NCT NCT02580305)
NCT ID: NCT02580305
Last Updated: 2023-06-09
Results Overview
Mean change from baseline at week 26 is assessed for ADAS-Cog11 score. The ADAS-Cog11 is a structured scale that evaluates memory, orientation, attention, reasoning, language, and constructional praxis. ADAS-Cog11 measures cognition by assessing 11 metrics impaired in AD: word recall; commands; constructional praxis; naming objects and fingers; ideational praxis; orientation; word recognition; remembering test instructions; spoken language ability; word-finding difficulty; and comprehension of spoken language. The scale ranges from 0 to 70, with higher scores indicate greater impairment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
564 participants
Primary outcome timeframe
Baseline to Week 26
Results posted on
2023-06-09
Participant Flow
Study centers located in the United States of America (USA) participated in the study
Participant milestones
| Measure |
SUVN-502 Low Dose (50 mg)
SUVN-502 Low dose (50 mg) adjunct to base treatment with Donepezil and Memantine
|
SUVN-502 High Dose (100 mg)
SUVN-502 High dose (100 mg) adjunct to base treatment with Donepezil and Memantine
|
Placebo
Placebo adjunct to base treatment with Donepezil and Memantine
|
|---|---|---|---|
|
Overall Study
STARTED
|
190
|
185
|
189
|
|
Overall Study
Safety Population
|
187
|
181
|
188
|
|
Overall Study
Modified Intent-to-treat (mITT) Population
|
184
|
176
|
183
|
|
Overall Study
COMPLETED
|
147
|
136
|
157
|
|
Overall Study
NOT COMPLETED
|
43
|
49
|
32
|
Reasons for withdrawal
| Measure |
SUVN-502 Low Dose (50 mg)
SUVN-502 Low dose (50 mg) adjunct to base treatment with Donepezil and Memantine
|
SUVN-502 High Dose (100 mg)
SUVN-502 High dose (100 mg) adjunct to base treatment with Donepezil and Memantine
|
Placebo
Placebo adjunct to base treatment with Donepezil and Memantine
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
15
|
19
|
10
|
|
Overall Study
Lack of Efficacy
|
5
|
0
|
2
|
|
Overall Study
Protocol Violation
|
4
|
9
|
6
|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
11
|
9
|
7
|
|
Overall Study
Randomized in error and never treated
|
4
|
8
|
5
|
Baseline Characteristics
SUVN-502 With Donepezil and Memantine for the Treatment of Moderate Alzheimer's Disease- Phase 2a Study
Baseline characteristics by cohort
| Measure |
SUVN-502 Low Dose (50 mg)
n=184 Participants
SUVN-502 Low dose (50 mg) adjunct to base treatment with Donepezil and Memantine
|
SUVN-502 High Dose (100 mg)
n=176 Participants
SUVN-502 High dose (100 mg) adjunct to base treatment with Donepezil and Memantine
|
Placebo
n=183 Participants
Placebo adjunct to base treatment with Donepezil and Memantine
|
Total
n=543 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
73.4 years
STANDARD_DEVIATION 8.08 • n=99 Participants
|
74.4 years
STANDARD_DEVIATION 6.97 • n=107 Participants
|
72.9 years
STANDARD_DEVIATION 7.23 • n=206 Participants
|
73.6 years
STANDARD_DEVIATION 7.46 • n=7 Participants
|
|
Age, Customized
Age group greater than or equal to 65 years
|
159 Participants
n=99 Participants
|
155 Participants
n=107 Participants
|
157 Participants
n=206 Participants
|
471 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=99 Participants
|
96 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
297 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
246 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
171 Participants
n=99 Participants
|
162 Participants
n=107 Participants
|
168 Participants
n=206 Participants
|
501 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
APO-E4 Carrier Status
Carrier one allele
|
77 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
240 Participants
n=7 Participants
|
|
APO-E4 Carrier Status
Carrier two allele
|
24 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
90 Participants
n=7 Participants
|
|
Mini-Mental State Examination
|
16.9 units on a scale
STANDARD_DEVIATION 2.21 • n=99 Participants
|
17.0 units on a scale
STANDARD_DEVIATION 2.47 • n=107 Participants
|
16.5 units on a scale
STANDARD_DEVIATION 2.48 • n=206 Participants
|
16.8 units on a scale
STANDARD_DEVIATION 2.39 • n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 26Population: modified intent to treat (mITT) population
Mean change from baseline at week 26 is assessed for ADAS-Cog11 score. The ADAS-Cog11 is a structured scale that evaluates memory, orientation, attention, reasoning, language, and constructional praxis. ADAS-Cog11 measures cognition by assessing 11 metrics impaired in AD: word recall; commands; constructional praxis; naming objects and fingers; ideational praxis; orientation; word recognition; remembering test instructions; spoken language ability; word-finding difficulty; and comprehension of spoken language. The scale ranges from 0 to 70, with higher scores indicate greater impairment.
Outcome measures
| Measure |
SUVN-502 Low Dose (50 mg)
n=184 Participants
SUVN-502 Low dose (50 mg) adjunct to base treatment with Donepezil and Memantine
|
SUVN-502 High Dose (100 mg)
n=176 Participants
SUVN-502 High dose (100 mg) adjunct to base treatment with Donepezil and Memantine
|
Placebo
n=183 Participants
Placebo adjunct to base treatment with Donepezil and Memantine
|
|---|---|---|---|
|
Change From Baseline to Week-26 in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11)
|
2.0 score on a scale
Standard Error 0.5
|
2.5 score on a scale
Standard Error 0.5
|
2.6 score on a scale
Standard Error 0.5
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: modified intent to treat (mITT) population
Clinical Dementia Rating-Sum of Boxes (CDR-SB) - Sum of Boxes CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.
Outcome measures
| Measure |
SUVN-502 Low Dose (50 mg)
n=184 Participants
SUVN-502 Low dose (50 mg) adjunct to base treatment with Donepezil and Memantine
|
SUVN-502 High Dose (100 mg)
n=176 Participants
SUVN-502 High dose (100 mg) adjunct to base treatment with Donepezil and Memantine
|
Placebo
n=183 Participants
Placebo adjunct to base treatment with Donepezil and Memantine
|
|---|---|---|---|
|
Change From Baseline to Week-26 in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)
|
1.3 score on a scale
Standard Error 0.2
|
1.0 score on a scale
Standard Error 0.2
|
1.2 score on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: modified intent to treat (mITT) population
The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score is a 23-item inventory. The ADCS-ADL measures both basic and instrumental activities of daily living The total ADCS-ADL score ranges from 0 to 78, with lower scores indicating greater disease severity.
Outcome measures
| Measure |
SUVN-502 Low Dose (50 mg)
n=184 Participants
SUVN-502 Low dose (50 mg) adjunct to base treatment with Donepezil and Memantine
|
SUVN-502 High Dose (100 mg)
n=176 Participants
SUVN-502 High dose (100 mg) adjunct to base treatment with Donepezil and Memantine
|
Placebo
n=183 Participants
Placebo adjunct to base treatment with Donepezil and Memantine
|
|---|---|---|---|
|
Change From Baseline to Week-26 in Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL)
|
-4.6 score on a scale
Standard Error 0.6
|
-3.4 score on a scale
Standard Error 0.6
|
-4.4 score on a scale
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: modified intent to treat (mITT) population
Neuropsychiatric Inventory (NPI) 12 item - Total Score NPI assesses psychopathology in participants with dementia and other neurologic disorders. Total score ranges from 12 to 144; higher scores indicate greater disease severity.
Outcome measures
| Measure |
SUVN-502 Low Dose (50 mg)
n=184 Participants
SUVN-502 Low dose (50 mg) adjunct to base treatment with Donepezil and Memantine
|
SUVN-502 High Dose (100 mg)
n=176 Participants
SUVN-502 High dose (100 mg) adjunct to base treatment with Donepezil and Memantine
|
Placebo
n=183 Participants
Placebo adjunct to base treatment with Donepezil and Memantine
|
|---|---|---|---|
|
Change From Baseline to Week-26 in Neuropsychiatric Inventory (NPI)
|
0.5 score on a scale
Standard Error 0.8
|
0.4 score on a scale
Standard Error 0.9
|
2.1 score on a scale
Standard Error 0.8
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: modified intent to treat (mITT) population
Change in Mini-Mental State Examination (MMSE) - Total Score Minimum Score - 0, Maximum Score - 30. Higher score means better outcome.
Outcome measures
| Measure |
SUVN-502 Low Dose (50 mg)
n=184 Participants
SUVN-502 Low dose (50 mg) adjunct to base treatment with Donepezil and Memantine
|
SUVN-502 High Dose (100 mg)
n=176 Participants
SUVN-502 High dose (100 mg) adjunct to base treatment with Donepezil and Memantine
|
Placebo
n=183 Participants
Placebo adjunct to base treatment with Donepezil and Memantine
|
|---|---|---|---|
|
Change From Baseline to Week-26 in Change in Mini Mental State Examination (MMSE)
|
-1.1 score on a scale
Standard Error 0.3
|
-1.1 score on a scale
Standard Error 0.3
|
-1.0 score on a scale
Standard Error 0.3
|
Adverse Events
SUVN-502 Low Dose (50 mg)
Serious events: 10 serious events
Other events: 50 other events
Deaths: 3 deaths
SUVN-502 High Dose (100 mg)
Serious events: 14 serious events
Other events: 44 other events
Deaths: 2 deaths
Placebo
Serious events: 12 serious events
Other events: 40 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
SUVN-502 Low Dose (50 mg)
n=187 participants at risk
SUVN-502 Low dose (50 mg) adjunct to base treatment with Donepezil and Memantine
|
SUVN-502 High Dose (100 mg)
n=181 participants at risk
SUVN-502 High dose (100 mg) adjunct to base treatment with Donepezil and Memantine
|
Placebo
n=188 participants at risk
Placebo adjunct to base treatment with Donepezil and Memantine
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
1.1%
2/181 • Number of events 2 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
1.1%
2/188 • Number of events 2 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Infections and infestations
Sepsis
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.55%
1/181 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
1.1%
2/188 • Number of events 2 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/181 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.53%
1/188 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Infections and infestations
Klebsiella sepsis
|
0.53%
1/187 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/181 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/188 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.55%
1/181 • Number of events 2 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/188 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.55%
1/181 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/188 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Nervous system disorders
Syncope
|
1.6%
3/187 • Number of events 3 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.55%
1/181 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/188 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Nervous system disorders
Dementia
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/181 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.53%
1/188 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.55%
1/181 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/188 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Nervous system disorders
Loss of consciousness
|
0.53%
1/187 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/181 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/188 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Nervous system disorders
Presyncope
|
0.53%
1/187 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/181 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/188 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.55%
1/181 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/188 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.55%
1/181 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/188 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.53%
1/187 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/181 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/188 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.55%
1/181 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/188 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.55%
1/181 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/188 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Injury, poisoning and procedural complications
Fall
|
0.53%
1/187 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/181 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.53%
1/188 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/181 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.53%
1/188 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/181 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.53%
1/188 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.55%
1/181 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/188 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.55%
1/181 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.53%
1/188 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.55%
1/181 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/188 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.55%
1/181 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/188 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/181 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.53%
1/188 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.55%
1/181 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/188 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Gastrointestinal disorders
Diaphragmatic hernia
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.55%
1/181 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/188 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.55%
1/181 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/188 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.53%
1/187 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/181 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/188 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
1.1%
2/181 • Number of events 2 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/188 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.55%
1/181 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/188 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
General disorders
Asthenia
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.55%
1/181 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/188 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
General disorders
Gait disturbance
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.55%
1/181 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/188 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
2/187 • Number of events 2 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/181 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/188 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/181 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.53%
1/188 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of unknown primary site
|
0.53%
1/187 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/181 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/188 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.55%
1/181 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/188 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/181 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.53%
1/188 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/181 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.53%
1/188 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/181 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.53%
1/188 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.55%
1/181 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/188 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/187 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.55%
1/181 • Number of events 1 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
0.00%
0/188 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
Other adverse events
| Measure |
SUVN-502 Low Dose (50 mg)
n=187 participants at risk
SUVN-502 Low dose (50 mg) adjunct to base treatment with Donepezil and Memantine
|
SUVN-502 High Dose (100 mg)
n=181 participants at risk
SUVN-502 High dose (100 mg) adjunct to base treatment with Donepezil and Memantine
|
Placebo
n=188 participants at risk
Placebo adjunct to base treatment with Donepezil and Memantine
|
|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
8.0%
15/187 • Number of events 16 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
11.6%
21/181 • Number of events 26 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
10.1%
19/188 • Number of events 22 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Nervous system disorders
Headache
|
6.4%
12/187 • Number of events 12 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
2.2%
4/181 • Number of events 4 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
3.7%
7/188 • Number of events 8 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.4%
12/187 • Number of events 14 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
5.0%
9/181 • Number of events 9 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
1.6%
3/188 • Number of events 3 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
|
Injury, poisoning and procedural complications
Fall
|
5.9%
11/187 • Number of events 16 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
5.5%
10/181 • Number of events 12 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
5.9%
11/188 • Number of events 12 • 26 Weeks
Safety population is considered for reporting total number of participants at risk.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60