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Donepezil · 3 trials · 2 indications
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...
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Donepezil is an investigational small molecule being studied for use in Alzheimer's Disease. It is being evaluated in clinical trials for patients with Alzheimer's Disease, including those with mild cognitive impairment who are at risk for the condition. The drug is not yet approved and remains in clinical development.
Donepezil is a small molecule being studied for Alzheimer's Disease. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being evaluated for its effects on cognition in patients with Alzheimer's Disease and mild cognitive impairment.
Donepezil is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials to evaluate the drug's effects in patients with Alzheimer's Disease. Merck is responsible for the ongoing research and development of this investigational therapy.
Donepezil is in Phase 2 clinical development for Alzheimer's Disease. It has completed three clinical trials, including a Phase 2 study. The drug remains investigational and has not been approved by regulatory authorities. All completed trials were randomized, double-blind, and placebo-controlled.
Donepezil has been studied in three completed clinical trials: NCT00777608, a Phase 1 study testing a computerized neuropsychological battery in Alzheimer's patients; NCT02064920, a Phase 2 study of computerized cognition testing in mild Alzheimer's patients; and NCT04730635, a Phase 1 cognition platform study in patients at risk for Alzheimer's Disease.
Donepezil is the generic name for the drug also known as Aricept. In the clinical trials listed, the drug is referred to as Donepezil. It is being studied by Merck & Company for use in Alzheimer's Disease, though the drug is not yet approved for this indication.