Conditions: Alzheimer's Disease
Keywords: Moderate-to-severe Alzheimer's Disease
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 915
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of long-term administration of 23 milligram (mg) donepezil sustained release (SR) in participants with moderate to severe Alzheimer's disease. Participants who complete study E2020-G000-326 (NCT00478205) with no ongoing serious adverse events (SAEs) and no serious adverse drug reactions will be eligible to enter the open-label extension study.

Detailed description:

Arms:
arm 1: Donepezil SR 23 mg once daily orally for 12 months to participants who received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326 (NCT00478205). arm 2: Donepezil SR 23 mg once daily orally for 12 months to participants who received donepezil 10 mg immediate release (IR) in the preceding double-blind study E2020-G000-326 (NCT00478205).

Interventions: intervention 1: Donepezil
Intervention descriptions: intervention 1: Donepezil SR 23 mg once daily orally.

Protocol document: