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

This study has been completed.
Sponsor:
Collaborator:
Eisai Limited
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00566501
First received: November 29, 2007
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Alzheimer's Disease
Drug: 23 mg SR in Study 326
Drug: 10 mg IR in Study 326
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Extension Study of 23 mg Donepezil SR in Patients With Moderate to Severe Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Long-term Safety as Measured by Incidence of Adverse Events During the 12 Month Treatment Period [ Time Frame: Throughout the study ( 12 months for all AEs and up to an additional 30 days for SAEs) ] [ Designated as safety issue: Yes ]
    Adverse events (AEs), including SAEs, were recorded from the time of consent. Recording of AEs ceased after the Final Visit or Early Termination Visit, except that SAEs were monitored for 30 days after study drug discontinuation.


Secondary Outcome Measures:
  • Mean Change From Baseline in MMSE Score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The Mini-Mental State Examination (MMSE) is a brief, 30-item test of cognitive function.

  • Mean Change From Baseline in SIB Score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The Severe Impairment Battery (SIB) evaluates the severity of cognitive dysfunction in patients with more advanced dementia.


Enrollment: 915
Study Start Date: December 2007
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 23 mg SR in Study 326
Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
Drug: 23 mg SR in Study 326
Patients will receive 23 mg donepezil SR orally, once daily for 12 months.
Other Name: Aricept
Experimental: 10 mg IR in Study 326
Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
Drug: 10 mg IR in Study 326
Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.

  Eligibility

Ages Eligible for Study:   45 Years to 91 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Patients:

  1. Written informed consent from the patient (if possible) or from the patient'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 without ongoing SAEs or history of serious adverse drug reactions during study E2020-G000-326.
  3. Patients must enroll in the present study within 3 days of completion of study E2020-G000-326
  4. Health: physically healthy and ambulatory or ambulatory-aided (ie, 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. Patients 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: Patients 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 patient 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 patient'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 patient (as determined by the investigator) to provide accurate data. Specifically, the caregiver must have sufficient contact with the patient to provide accurate reports of the patient's functioning, must be able to observe for possible adverse events, and must be able to accompany the patient to all visits. It is preferable that the caregiver be the same as in study E2020-G000-326. If no replacement caregiver is available who meets the caregiver inclusion/exclusion criteria, the patient must be discontinued from the study.

Exclusion Criteria for Patients:

  1. No caregiver available to meet the inclusion criteria for caregivers.
  2. Patients with any active or clinically-significant conditions affecting absorption, distribution, or metabolism of the study medication (e.g., 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. Patients 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 patient, in the opinion of the investigator, unsuitable for the study.
  7. Patients 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. Patients who cannot swallow or who have difficulty swallowing whole tablets.
  9. Patients 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00566501

Locations
United States, California
Apex Research Institute
Santa Ana, California, United States, 92705
Sponsors and Collaborators
Eisai Inc.
Eisai Limited
Investigators
Study Director: Jane Yardley, Ph.D Eisai Limited
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00566501     History of Changes
Other Study ID Numbers: E2020-G000-328
Study First Received: November 29, 2007
Results First Received: May 16, 2012
Last Updated: May 16, 2012
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency

Keywords provided by Eisai Inc.:
Moderate-to-severe
Alzheimer's
Disease

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014