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Label indication NAMZARIC is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily. NAMZARIC is a combination of memantine hydrochloride, an NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor, indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized… FDA label
donepezil · 2 trials · 2 indications
Of the four cohorts with different dosing schedules for CPC-201, the cohort with the greatest proportion of participants to reach the donepezil MAD was determined to be the optimal administration regimen.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Donepezil 20mg/day upward dose titration of 10mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day. |
| Cohort 2 | EXPERIMENTAL | Donepezil 20mg/day upward dose titration of 20mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day. |
| Cohort 1b | EXPERIMENTAL | Donepezil 10mg/day upward dose titration of 10mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day. |
| Cohort 3c | EXPERIMENTAL | Donepezil 10mg/day upward dose titration of 5mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 40mg/day with solifenacin 15mg/day. |
| sugar pill | PLACEBO_COMPARATOR | - |
| donepezil | ACTIVE_COMPARATOR | - |
| ABT-126 Low Dose | EXPERIMENTAL | low dose |
| ABT-126 Middle Dose | EXPERIMENTAL | middle dose |
| ABT-126 high dose | EXPERIMENTAL | high dose |
| Name | Type | Description |
|---|---|---|
| Donepezil | DRUG | Donepezil dose increased at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) together with solifenacin. |
| Solifenacin | DRUG | Donepezil dose increased at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) together with solifenacin. |
| placebo | DRUG | Placebo Comparator |
| ABT-126 | DRUG | low dose, middle dose, high dose |
Inclusion Criteria: 1. Signed an Institutional Review Board (IRB) approved informed consent document 2. Aged 50 - 89 years inclusive. 3. Meeting the diagnosis of probable AD consistent with: * Revised National Institute on Aging-Alzheimer's Disease Association (NIA-ADA) criteria and * Diagno...
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Donepezil is being studied for Alzheimer's Disease and Dementia of Alzheimer's Type. It is an investigational small molecule in Phase 2 clinical development, not an approved therapy. The research focuses on patients with mild to moderate Alzheimer's Disease and related dementia, with trials enrolling adults aged 50 and older.
Donepezil targets acetylcholinesterase (ACHE) as an inhibitor. By inhibiting this enzyme, donepezil is designed to increase acetylcholine levels in the brain, which is the mechanism under investigation for treating Alzheimer's Disease and Dementia of Alzheimer's Type.
Donepezil is being developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the sponsor of the clinical trials evaluating this small molecule for Alzheimer's Disease and Dementia of Alzheimer's Type.
Donepezil is in Phase 2 clinical development. It is an investigational therapy and has not been approved by the FDA for any indication. The Phase 2 program includes completed trials assessing the drug in patients with Alzheimer's Disease and Dementia of Alzheimer's Type.
Donepezil has been evaluated in two completed Phase 2 trials. NCT02549196 was a dose titration study of CPC-201 in patients with Dementia of Alzheimer's Type, enrolling 28 participants in the United States. NCT01527916 evaluated ABT-126 in 438 subjects with mild to moderate Alzheimer's Disease across the United States, Poland, Russia, South Africa, Ukraine, and the United Kingdom.