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Donepezil · 3 trials · 4 indications
The VABS-II/PCRF instrument was used in this study to assess 3 domains (each with 3 sub-domains): communication (sub-domains: receptive, expressive, and writing), daily living skills (sub-domains: personal, domestic, community), and socialization (sub-domains: interpersonal relationships, play/leisure time, coping skills). Raw scores (2=always present, 1=sometimes present, 0=seldom or never present) rated by the parent/caregiver from each sub-domain were converted to standardized scores called V-scores, which are based on age and a national sample of normal children. Each sub-domain v-scale score ranged from 1 (weakness) to 24 (strength). V-scores for the 9 sub-domains were summed to obtain a composite V-score ranging from 9 to 216. Higher scores indicate a higher level of adaptive functioning. A positive change from baseline indicates an improvement in adaptive functioning. Composite V-scores have a mean (50th percentile) of 100 and a standard deviation (SD) of 15.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Donepezil HCl | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Donepezil hydrochloride | DRUG | - |
| Donepezil (Aricept) | DRUG | Donepezil (Aricept) 5 mg tablet orally once daily for 30 days, followed by 10 mg tablet orally once daily to complete 6 months of treatment |
| Placebo | DRUG | Matching placebo tablets orally once daily for 6 months |
| Donepezil HCl | DRUG | Blinded donepezil 2.5 milligram per day (mg/day) (2.5 milliliter per day \[mL/day\]) orally for participants with body weight (BW) 20 and less than (\<) 25 kilogram (kg), 5 mg/day (5 mL/day) orally for participants with BW 25 to \<50 kg, and 10 mg/day (10 mL/day) orally for participants with BW greater than or equal to (\>=) 50 kg liquid formulation (1 milligram per 1 milliliter \[1 mg/1 mL\]) (titrated to 0.1 to 0.2 milligram per kilogram per day \[mg/kg/day\] based on BW). |
Inclusion Criteria: * Clinically diagnosed Alzheimer's Disease with MMSE score 1\~12 * Have not been treated by any medication for Alzheimer's Disease in past 3 months * Live in community or Assisted Living Facility * Healthy or with chronic diseases that are medically controlled or stabilized * Ab...
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Donepezil is used for Alzheimer's Disease, including severe Alzheimer's Disease and dementia, and for cognitive dysfunction in children with Down Syndrome. It is being studied in clinical trials for these conditions, with completed trials in Alzheimer's Disease and Down Syndrome.
Donepezil is a small molecule that targets the cholinergic system, specifically inhibiting acetylcholinesterase, which increases acetylcholine levels in the brain. This mechanism is relevant to cognitive symptoms in Alzheimer's Disease and Down Syndrome.
Donepezil is developed by Pfizer, Inc., which trades under the ticker PFE. The company is conducting clinical trials for the drug in Alzheimer's Disease and Down Syndrome.
Donepezil is in Phase 3 clinical development for Alzheimer's Disease, with completed Phase 3 trials. It has also completed a Phase 2 trial for Down Syndrome. It is investigational and not yet approved for these indications.
Donepezil has completed several clinical trials, including NCT00096473 for severe Alzheimer's Disease, NCT00570128 for Down Syndrome, and NCT00630851 for severe Alzheimer's Disease in nursing homes. These trials were placebo-controlled and double-blind.
Yes, Donepezil is also known as Aricept. Clinical trials such as NCT00096473 and NCT00630851 refer to Aricept, while NCT00570128 uses the name Donepezil Hydrochloride (HCl) (Aricept).