Trial Outcomes & Findings for Computerized Cognition Testing in Participants With Mild Alzheimer's Disease (AD) Treated With Donepezil (MK-0000-318) (NCT NCT02064920)
NCT ID: NCT02064920
Last Updated: 2018-10-12
Results Overview
OCL is one of the Cogstate battery of tests, and is a continuous visual recognition task that assesses visual recognition, memory and attention using a pattern separation algorithm. OCL is a score defined as the arcsine transformation of the square root of the proportion of correct responses to 80 OCL questions. The score ranges from 0 to 1.5708 where a higher score means better performance.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Weeks 4, 8, 12 and 16
Results posted on
2018-10-12
Participant Flow
Males and females with mild Alzheimer's Disease (AD) between the ages of 55 and 85 years (inclusive) were enrolled in this trial.
Participant milestones
| Measure |
Placebo
Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks.
|
Donepezil
During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
30
|
|
Overall Study
Treated
|
6
|
28
|
|
Overall Study
COMPLETED
|
5
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
9
|
Reasons for withdrawal
| Measure |
Placebo
Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks.
|
Donepezil
During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
4
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Technical Problems
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
Baseline Characteristics
Computerized Cognition Testing in Participants With Mild Alzheimer's Disease (AD) Treated With Donepezil (MK-0000-318)
Baseline characteristics by cohort
| Measure |
Placebo
n=6 Participants
Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks.
|
Donepezil
n=30 Participants
During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76.7 Years
STANDARD_DEVIATION 8.6 • n=99 Participants
|
72.7 Years
STANDARD_DEVIATION 8.7 • n=107 Participants
|
73.4 Years
STANDARD_DEVIATION 8.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Weeks 4, 8, 12 and 16Population: All participants who received study medication and yielded at least one measurement for that endpoint.
OCL is one of the Cogstate battery of tests, and is a continuous visual recognition task that assesses visual recognition, memory and attention using a pattern separation algorithm. OCL is a score defined as the arcsine transformation of the square root of the proportion of correct responses to 80 OCL questions. The score ranges from 0 to 1.5708 where a higher score means better performance.
Outcome measures
| Measure |
Placebo
n=5 Participants
Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks.
|
Donepezil
n=28 Participants
During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability.
|
|---|---|---|
|
One-card Learning (OCL) Measurement Over 12 Weeks of Treatment
Week 4 (n = 5, 28)
|
0.954 Score on a scale
Standard Deviation 0.091
|
0.942 Score on a scale
Standard Deviation 0.112
|
|
One-card Learning (OCL) Measurement Over 12 Weeks of Treatment
Week 8 (n = 5, 22)
|
0.822 Score on a scale
Standard Deviation 0.179
|
0.969 Score on a scale
Standard Deviation 0.104
|
|
One-card Learning (OCL) Measurement Over 12 Weeks of Treatment
Week 12 (n = 5, 21)
|
0.849 Score on a scale
Standard Deviation 0.132
|
0.984 Score on a scale
Standard Deviation 0.118
|
|
One-card Learning (OCL) Measurement Over 12 Weeks of Treatment
Week 16 (n = 5, 21)
|
0.961 Score on a scale
Standard Deviation 0.123
|
0.993 Score on a scale
Standard Deviation 0.112
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12 and 16Population: All participants who received study medication and yielded at least one measurement for that endpoint.
OCL is one of the Cogstate battery of tests, and is a continuous visual recognition task that assesses visual recognition, memory and attention using a pattern separation algorithm. The percentage of correct responses to 80 OCL questions is defined as the number of correct responses x 100 divided by the number of total responses; and ranges from 0 to 100, where 100 is best, and 0 is the worst outcome.
Outcome measures
| Measure |
Placebo
n=5 Participants
Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks.
|
Donepezil
n=28 Participants
During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability.
|
|---|---|---|
|
Percentage of Correct Responses in the OCL Task Over 12 Weeks of Treatment
Week 4 (n = 5, 28)
|
66.2 Percentage of Corrrect Responses
Standard Deviation 8.3
|
64.9 Percentage of Corrrect Responses
Standard Deviation 10.3
|
|
Percentage of Correct Responses in the OCL Task Over 12 Weeks of Treatment
Week 8 (n = 5, 22)
|
53.7 Percentage of Corrrect Responses
Standard Deviation 17.1
|
67.4 Percentage of Corrrect Responses
Standard Deviation 9.5
|
|
Percentage of Correct Responses in the OCL Task Over 12 Weeks of Treatment
Week 12 (n = 5, 21)
|
56.1 Percentage of Corrrect Responses
Standard Deviation 12.7
|
68.6 Percentage of Corrrect Responses
Standard Deviation 10.4
|
|
Percentage of Correct Responses in the OCL Task Over 12 Weeks of Treatment
Week 16 (n = 5, 21)
|
66.7 Percentage of Corrrect Responses
Standard Deviation 11.6
|
69.5 Percentage of Corrrect Responses
Standard Deviation 9.8
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Donepezil
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=6 participants at risk
Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks.
|
Donepezil
n=28 participants at risk
During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability.
|
|---|---|---|
|
General disorders
Chest pain
|
0.00%
0/6 • Up to Week 18 (approximately up to 129 days)
All participants who received study medication.
|
3.6%
1/28 • Number of events 1 • Up to Week 18 (approximately up to 129 days)
All participants who received study medication.
|
Other adverse events
| Measure |
Placebo
n=6 participants at risk
Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks.
|
Donepezil
n=28 participants at risk
During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 1 • Up to Week 18 (approximately up to 129 days)
All participants who received study medication.
|
14.3%
4/28 • Number of events 4 • Up to Week 18 (approximately up to 129 days)
All participants who received study medication.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • Number of events 1 • Up to Week 18 (approximately up to 129 days)
All participants who received study medication.
|
0.00%
0/28 • Up to Week 18 (approximately up to 129 days)
All participants who received study medication.
|
|
Investigations
Blood urea increased
|
16.7%
1/6 • Number of events 1 • Up to Week 18 (approximately up to 129 days)
All participants who received study medication.
|
0.00%
0/28 • Up to Week 18 (approximately up to 129 days)
All participants who received study medication.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Up to Week 18 (approximately up to 129 days)
All participants who received study medication.
|
7.1%
2/28 • Number of events 2 • Up to Week 18 (approximately up to 129 days)
All participants who received study medication.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • Up to Week 18 (approximately up to 129 days)
All participants who received study medication.
|
7.1%
2/28 • Number of events 2 • Up to Week 18 (approximately up to 129 days)
All participants who received study medication.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Up to Week 18 (approximately up to 129 days)
All participants who received study medication.
|
7.1%
2/28 • Number of events 3 • Up to Week 18 (approximately up to 129 days)
All participants who received study medication.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
- Publication restrictions are in place
Restriction type: OTHER