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

NCT00566501 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: E2020-G000-3282006-004890-93
• Study Type: interventional
• Target: 915
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Keywords

Moderate-to-severe; Alzheimer's; Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product, a change in treatment, or discontinuation of study drug, recurrence of an intermittent medical condition not present pretreatment, an abnormal laboratory test result was considered an AE if the identified laboratory abnormality led to any type of intervention, withdrawal of study drug, or withholding of study drug, whether prescribed in the protocol or not. All AEs in Study 328 (NCT00566501) excluding treatment-emergent signs or symptoms continuing from Study 326 (NCT00478205) were reported.

  From the enrollment of the study up to 30 days after last dose of the study drug (up to 2 years 3 months)

Secondary Outcomes (11)

• Percentage of Participants With at Least 1 Treatment-Emergent Abnormal Laboratory Values (TEAVs): Hematology

  From the first dose of study drug up to 2 years 3 months

• Percentage of Participants With at Least 1 TEAVs for Selected Parameters: Clinical Chemistry

  From the first dose of study drug up to 2 years 3 months

• Change From Baseline in Severe Impairment Battery (SIB) Total Score

  At Baseline, Month 3, Month 6, Month 9 and Month 12

• Change From Baseline in Mini-Mental State Examination (MMSE) Total Score

  At Baseline, Month 3, Month 6, Month 9 and Month 12

• Change From Baseline in Modified Alzheimer's Disease Cooperative Study Activities of Daily Living Severe Scale (ADCS-ADL) Total Score

  At Baseline, Month 3, Month 6, Month 9 and Month 12

Study Arms (2)

Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205)

EXPERIMENTAL

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).

Drug: Donepezil

Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205)

EXPERIMENTAL

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).

Drug: Donepezil

Interventions

Donepezil DRUG

Donepezil SR 23 mg once daily orally.

Also known as: Aricept

Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205); Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205)

Eligibility Criteria

• Age: 45 Years - 91 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.
• Participants who are unwilling or unable to fulfill the requirements of the study.
• Use of any prohibited prior or concomitant medications.
• Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study.
• 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.
• Participants who cannot swallow or who have difficulty swallowing whole tablets.
• 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.
• Caregivers who are unwilling or unable to give informed consent or otherwise to fulfill the requirements of the study.
• Any condition that would make the caregiver, in the opinion of the investigator, unsuitable for the study.

Sponsors & Collaborators

• Eisai Inc.: lead
• Eisai Limited: collaborator

Study Sites (1)

Apex Research Institute

Santa Ana, California, 92705, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Disease

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Eisai Medical Information
• Organization: Eisai, Inc.

esi_medinfo@eisai.com

+1-888-274-2378

Study Officials

• Jane Yardley, Ph.D

  Eisai Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2007
• First Posted: December 3, 2007
• Study Start: December 14, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: November 17, 2021
• Results First Posted: June 19, 2012

Record last verified: 2021-10

Locations

US (1)