Open-Label Extension Study of 23 mg Donepezil SR in Participants With Moderate to Severe Alzheimer's Disease

Inclusion criteria

• ✓. Written informed consent from the participant (if possible) or from the participant's legal guardian or other representative at the time of the Baseline visit, prior to beginning any assessments or activities.
• ✓. Completion of study E2020-G000-326 (NCT00478205) without ongoing SAEs or history of serious adverse drug reactions during study E2020-G000-326 (NCT00478205).
• ✓. Participant must enroll in the present study within 3 days of completion of study E2020-G000-326 (NCT00478205).
• ✓. Health: physically healthy and ambulatory or ambulatory-aided (that is, walker or cane); corrected vision and hearing sufficient for compliance with testing procedures.
• ✓. Co-morbid medical conditions must be well-controlled as determined by the investigator.
• ✓. Participants undergoing treatment with selective serotonin reuptake inhibitors (SSRIs) may be included, provided that doses are within the approved dose range as specified in the Physician's Desk Reference or local equivalent
• ✓. Concomitant Medications: Participants undergoing treatment with the following medications may be enrolled in the study provided the following conditions are met: chronic daily benzodiazepine use if doses are stable within an approved dose range; bronchodilator medications for treatment of chronic obstructive pulmonary disease (COPD) as long as drug is administered via metered dose inhaler within approved dose range; memantine if taken at doses of 20 mg/day or less, provided that the dose is stable.
• ✓. The participants must have a relative/caregiver who supervises the regular taking of the drug at the correct dose and is alert for possible side effects, unless the participant's legal guardian takes on this task.

Exclusion criteria