Open-Label Extension Study of 23 mg Donepezil SR in Participants With Moderate to Severe Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Donepezil
Intervention description: Donepezil SR 23 mg once daily orally.
Intervention MeSH terms: Donepezil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 915.0
Sex: All
Minimum age: 45 Years
Maximum age: 91 Years
Healthy volunteers: No
Keywords: Moderate-to-severe; Alzheimer's; Disease

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.
    

Eligibility criteria:

        Inclusion Criteria for Participants:

          1. 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.

          2. Completion of study E2020-G000-326 (NCT00478205) without ongoing SAEs or history of
             serious adverse drug reactions during study E2020-G000-326 (NCT00478205).

          3. Participant must enroll in the present study within 3 days of completion of study
             E2020-G000-326 (NCT00478205).

          4. Health: physically healthy and ambulatory or ambulatory-aided (that is, walker or
             cane); corrected vision and hearing sufficient for compliance with testing procedures.

          5. Co-morbid medical conditions must be well-controlled as determined by the
             investigator.

          6. 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

          7. 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.

          8. 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.

        Inclusion Criteria for Caregivers. Written informed consent will be obtained from the
        designated caregiver for participation in study assessments. The caregiver must be
        sufficiently familiar with the participant (as determined by the investigator) to provide
        accurate data. Specifically, the caregiver must have sufficient contact with the
        participant to provide accurate reports of the participant's functioning, must be able to
        observe for possible adverse events, and must be able to accompany the participant to all
        visits. It is preferable that the caregiver be the same as in study E2020-G000-326
        (NCT00478205). If no replacement caregiver is available who meets the caregiver
        inclusion/exclusion criteria, the participant must be discontinued from the study.

        Exclusion Criteria for Participants:

          1. No caregiver available to meet the inclusion criteria for caregivers.

          2. Participants with any active or clinically-significant conditions affecting
             absorption, distribution, or metabolism of the study medication (example, inflammatory
             bowel disease, gastric or duodenal ulcers, hepatic disease, or severe lactose
             intolerance).

          3. Known plan for elective surgery during the study period that would require general
             anesthesia and administration of neuromuscular blocking agents, such as
             succinylcholine, to induce paralysis/muscle relaxation. Minor surgery, such as
             colonoscopy or cataract surgery, will be permitted as long as it does not require the
             use of these paralytic agents.

          4. Participants who are unwilling or unable to fulfill the requirements of the study.

          5. Use of any prohibited prior or concomitant medications.

          6. Any condition that would make the participant, in the opinion of the investigator,
             unsuitable for the study.

          7. Participant taking concomitant antidepressant medication known to have significant
             anticholinergic effects, such as tricyclic antidepressants prescribed at doses
             recommended for the treatment of major depression.

          8. Participants who cannot swallow or who have difficulty swallowing whole tablets.

          9. Participants taking any alternative medication such as vitamins and/or herbal products
             or alternative medical techniques such as acupuncture or acupressure specifically for
             the treatment of Alzheimer's disease.

        Exclusion Criteria for Caregivers.

          1. Caregivers who are unwilling or unable to give informed consent or otherwise to
             fulfill the requirements of the study.

          2. Any condition that would make the caregiver, in the opinion of the investigator,
             unsuitable for the study.