Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02064920 | Computerized Cognition Testing in Participants With Mild Alzheimer's Disease (AD) Treated With Donepezil (MK-0000-318) | PHASE2 | COMPLETED | 36 | — | — | Apr 22, 2014 | Jul 13, 2016 | Oct 12, 2018 | - | — |
| NCT04730635 | Cognition Platform Study in Participants at Risk for Alzheimer's Disease (AD) (MK-0000-413) | PHASE1 | COMPLETED | 44 | — | — | Mar 23, 2021 | Feb 6, 2023 | Oct 28, 2024 | 10 | United States, Australia |
| NCT00777608 | A Study to Test the Performance of the CogState Computerized Neuropsychological Battery in Patients With Alzheimer's Disease (0000-086)(COMPLETED) | PHASE1 | COMPLETED | 106 | — | — | Dec 1, 2008 | Apr 1, 2010 | Aug 25, 2015 | - | — |
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.
One Card Learning (OCL) uses a pattern separation paradigm to assess visual memory. The change from baseline of correct responses on the OCL task up to Week 8 is compared in participants receiving donepezil with participants receiving placebo. Change from baseline was the averaged correct response rate at Week 8 minus the correct response rate at baseline.
CogState is a simple, brief computerized neuropsychological battery to evaluate cognitive impairments characterizing mild-to-moderate Alzheimer's Disease (AD). The composite CogState assesses attention and memory functions - including Verbal episodic memory, Visual Episodic Memory, Psychomotor function, Visual attention and working memory. CogState scores are measured on a linear scale (with no maximum score) and a reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change in the CogState Composite Score at Week 4 compared to baseline.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks. |
| Donepezil | EXPERIMENTAL | 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. |
| Donepezil 5-10 mg | EXPERIMENTAL | There will be a 14 day period when all participants will receive placebo, followed by 5 mg donepezil, once daily for 14 days then titrated to 10 mg donepezil once daily for 70 days. Participants may then receive open-label donepezil for an additional 24 weeks. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo for donepezil hydrochloride capsule |
| Donepezil | DRUG | 5 mg donepezil hydrochloride capsule. |
| Comparator: Placebo 5mg (run in) | DRUG | Matching placebo to donepezil - 5 mg capsules orally for 14 day run in prior to randomization. |
| Donepezil 5 - 10 mg | DRUG | Donepezil 1 capsule (5 mg) orally, once daily for 14 days. Donepezil 2 capsules (total 10 mg) once daily for 70 days (days 15-84). |
| Comparator: Placebo 5-10 mg | DRUG | Matching placebo to donepezil, 1 capsule (5 mg) orally, once daily for 14 days. Matching placebo to donepezil 2 capsules (total 10 mg) once daily for 70 days (days 15-84). |
| Donepezil 10 mg | DRUG | Donepezil 2 capsules (total 10 mg) orally, once daily for 24 weeks, from day 85 (optional). |
Inclusion Criteria: * Meets listed criteria for a diagnosis of probable AD * Has a clearly documented history either in medical records or from an informant of cognitive decline over at least 6 months * Has a reliable partner/caregiver who is willing to provide input by participating in assessments...