The Effectiveness And Safety Of Donepezil Hydrochloride (E2020) In Subjects With Mild To Severe Alzheimer's Disease Residing In An Assisted Living Facility

NCT00571064 | Completed Phase 4 Results

• 1 other identifier: E2020-A001-415
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 36

Brief Summary

This is a study to determine the effectiveness and safety of donepezil hydrochloride (E2020) used to treat residents of assisted living facilities diagnosed with mild, moderate, or severe stage Alzheimer's disease.

Conditions

Mild to Severe Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

• Mini Mental State Examination (MMSE) Total Scores by Visit

  The MMSE was a brief test that assessed the cognitive status of the participant. The 30-point test included items that evaluate orientation to time and place, immediate and delayed recall, attention, language, and construction. The total number of correct responses was obtained. The scores ranged from 0 to 30, with higher scores representing better performance. Summaries and analyses in the Intent-to-Treat (ITT) population were carried out using observed cases at each visit. A Study Endpoint evaluation was performed using the last observation carried forward (LOCF) from the open label treatment phase for each participant. The outcome of the study was based on analyses of the primary efficacy variable at Study Endpoint, which was defined as end of study assessment, using the ITT population with LOCF.

  Baseline (Visit 2), Week 6 (Visit 3), Week 12 (Visit 4) or Early Termination (ET) Visit, Week 12 LOCF (Study Endpoint)

• Change From Baseline in MMSE Total Score by Visit

  The MMSE was a brief test that assessed the cognitive status of the participant. The 30-point test included items that evaluated orientation to time and place, immediate and delayed recall, attention, language, and construction. The total number of correct responses was obtained. The scores ranged from 0 to 30, with higher scores representing better performance. Summaries and analyses in the ITT population were carried out using observed cases at each visit. A Study Endpoint evaluation was performed using the LOCF from the open label treatment phase for each participant. The outcome of the study was based on analyses of the primary efficacy variable at Study Endpoint, which was defined as end of study assessment, using the ITT population with LOCF. Change from Baseline in MMSE Total Score at Week 6 (Visit 3), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint) has been reported.

  Baseline, Week 6 (Visit 3), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)

Secondary Outcomes (8)

• Caregiver Activity Survey (CAS) Total Time by Visit

  Baseline (Visit 2), Week 6 (Visit 3), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)

• Change From Baseline in CAS Total Time by Visit

  Baseline, Week 6 (Visit 3), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)

• Neuropsychiatric Inventory (NPI-8) Total Score by Visit

  Baseline (Visit 2), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)

• Change From Baseline in NPI-8 Total Score by Visit

  Baseline, Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)

• Alzheimer Disease-related Quality of Life (ADRQL) Total Score by Visit

  Baseline (Visit 2), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)

Study Arms (1)

1

EXPERIMENTAL

Drug: Donepezil HCl

Interventions

Donepezil HCl DRUG

One 5 mg tablet per day (for the first 6 weeks) with a full glass of water. For the last 6 weeks, one 10mg tablet per day with a full glass of water.

Also known as: Aricept

1

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range: Subjects \> 50 years of age.
• Sex distribution: both men and women. Women must be two (2) years post-menopausal or surgically sterile. Women of child bearing potential (\< 1 year post menopausal) must be practicing effective contraception and have a negative ß-hCG at screening (Women who are breast feeding are excluded).
• MMSE scores between 5 and 24 (inclusive).
• Subjects must have diagnostic evidence of possible or probable AD either prior to or at the screening visit based on Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) and National Institute of Neurological and Communicative Disorders and Stroke criteria.
• CT or MRI within the last 12 months consistent with a diagnosis of AD without any other clinically significant comorbid pathologies found. A copy of the report will be required and will be collected. If there has been a significant change in clinical status suggestive of stroke or other neurological disease in addition to AD with onset between the time of the last CT or MRI and the screening evaluation, the scan should be repeated during screening.
• The caregiver/ informant can be a family member or a professional and must have had contact with the subject at least 6 Weeks prior to study entry and spent at minimum 3 days a Week (10 hours per Week) with the subject. For study visit, the subject can be seen at the Assisted Living Facility (ALF) or in the clinic setting of the Investigator. At each visit, the caregiver/informant will provide the information for completion of the safety and efficacy assessments based on knowledge of and time spent with the subject.
• Subjects must reside in an ALF.
• The subject is expected to complete all procedures scheduled during the screening, baseline, interim, and final visits including all efficacy assessments.
• Putative non-prescription/prescription cognitive enhancers (e.g. ginkgo, high-dose vitamin E, lecithin, estrogen, non-steroidal anti-inflammatory drugs \[NSAIDs\]) will not be excluded but will be discouraged. If a putative cognitive enhancer is present, the dosage must have been stable for at least 3 months prior to the screening visit and should not change during the course of the study.
• Subjects with controlled hypertension (sitting diastolic BP \< 95 mmHg), right bundle branch block (complete or partial), and pacemakers may be included in the study.
• Subjects with thyroid disease also may be included in the study provided they are euthyroid and stable on treatment for at least 3 months prior to screening.
• Subjects with a history of seizure disorder are allowed provided that they are on stable treatment for at least 3 months prior to screening and have not had a seizure within the past 6 months.
• Subjects must be able to swallow tablet medication -- no crushing of tablet is allowed.
• Health: independent or ambulatory aided (i.e., walker or cane, to wheelchair); vision and hearing (eyeglasses and/or hearing aid permissible) sufficient for compliance with testing procedures.
• Subjects must be sufficiently proficient in the language in which the assessments are to be conducted.

You may not qualify if:

• Age range: Subjects \< 50 years of age.
• MMSE score of ≤4 or ≥25.
• Subjects with active or clinically significant conditions affecting absorption, distribution or metabolism of the study medication (e.g., inflammatory bowel disease, gastric or duodenal ulcers or severe lactose intolerance).
• Subjects with a known hypersensitivity to piperidine derivatives or cholinesterase inhibitors.
• Subjects living in a skilled nursing home or subjects living in an ALF who may be moved to a skilled nursing home during the course of the study. Subjects who transfer from an ALF to a skilled nursing home during this study will be discontinued.
• Subjects who have taken the following medications within the last 3 months prior to screening will be not eligible: Aricept, Exelon, Cognex, Razadyne, Metrifonate, Namenda or propentofylline.
• Subjects without a reliable caregiver/informant or subjects whose caregiver is unwilling or unable to complete the outcome measures and fulfill the requirements of this study.
• Subjects with clinically significant obstructive pulmonary disease or asthma, untreated for \> 3 months.
• Subjects with recent (\< 2 years) hematologic/ oncologic disorders, not including mild anemia or basal or squamous cell carcinoma of the skin. Subjects with current evidence of malignant neoplasm or recurrent or metastatic disease will be excluded.
• Evidence of clinically significant, active gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease.
• Subject with a current DSM-lV diagnosis of Major Depressive Disorder (MDD) or any current primary psychiatric diagnosis other than Alzheimer's disease (as per DSM-lV).
• Subjects with dementia complicated by other organic disease (DSM 290.30 or 290.11) are excluded; depression or delusions are common in Alzheimer's disease, and subjects with severe symptoms so pronounced that they warrant an alternative, concurrent diagnosis, are excluded.
• Subjects with a known or suspected history of alcoholism or drug abuse (within the past 10 years).
• Subjects with treated hypothyroidism that have not been on a stable dose of medication for 3 months prior to screening and who do not have normal serum Free T3, Free T4 and TSH at screening.
• Subjects with treated vitamin B-12 deficiency who have not been on a stable dose of medication for at least 3 months prior to the study screening visit and who do not have normal serum B-12 levels at screening.

Sponsors & Collaborators

• Eisai Inc.: lead
• Pfizer: collaborator

Study Sites (36)

Senior Care

Birmingham, Alabama, 35209, United States

Location

21st Century Neurology

Phoenix, Arizona, 85004, United States

Location

Psypharma Clinical Research

Phoenix, Arizona, 85050, United States

Location

South Coast Clinical Trials

Anaheim, California, 38204, United States

Location

AVI Clinical Research

Carson, California, 90746, United States

Location

Margolin Brain Institute

Fresno, California, 93720, United States

Location

Sarah Sam Olelewe, MD Inc

Hawthorne, California, 90250, United States

Location

Neuropsychiatric Research Center of Orange County

Santa Ana, California, 92701, United States

Location

Danbury Clinical Research, LLC

Danbury, Connecticut, 06810, United States

Location

Research Center for Clinical Studies

Norwalk, Connecticut, 06851, United States

Location

Neuroscience Consultants

Miami, Florida, 33176, United States

Location

Galiz Research

Miami Springs, Florida, 33166, United States

Location

Universal Clinical research and Technology

Orlando, Florida, 32833, United States

Location

Byrd's Alzheimer Institute

Tampa, Florida, 33613, United States

Location

Stedman Clinical Trials, LLC

Tampa, Florida, 33613, United States

Location

Center for Clinical Trials

Venice, Florida, 34285, United States

Location

Rush Alzheimer Disease Center

Chicago, Illinois, 92804, United States

Location

Alexian Brothers Neuroscience Institute

Elk Grove, Illinois, 60007, United States

Location

Agewell Health Ltd

Indianapolis, Indiana, 46260, United States

Location

Venture Resource Group Inc

Mission, Kansas, 66202, United States

Location

Four Rivers Clinical Research

Paducah, Kentucky, 42003, United States

Location

McLean Hospital Geriatric Psychiatry

Belmont, Massachusetts, 02478, United States

Location

Neuroscience Research of the Bershires

Pittsfield, Massachusetts, 01201, United States

Location

Horne Research

Las Vegas, Nevada, 89102, United States

Location

Bio Behavioral Health

Toms River, New Jersey, 08755, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Neurological Associates of Albany, PC

Albany, New York, 12208, United States

Location

University Of Buffalo

Buffalo, New York, 14215, United States

Location

University of Rochester, Monroe Community Hospital

Rochester, New York, 14620, United States

Location

Valley Medical Research

Centerville, Ohio, 45959, United States

Location

Infinity Research Group

Oklahoma City, Oklahoma, 73103, United States

Location

University of Pennsylvania, Section of Geriatric Psychiatry

Philadelphia, Pennsylvania, 19104, United States

Location

Rhode Island Mood and Memory Research Institute

East Providence, Rhode Island, 02914, United States

Location

CNS Research, INC

East Providence, Rhode Island, 02916, United States

Location

Senior Adults Specialty Research

Austin, Texas, 78757, United States

Location

Mech Center

Plano, Texas, 75024, United States

Location

MeSH Terms

Interventions

Donepezil

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 Services
• Organization: Eisai Inc.

1-888-422-4743

Study Officials

• James Prodafikas, MD

  Eisai Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2007
• First Posted: December 11, 2007
• Study Start: January 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: April 22, 2009
• Last Updated: September 27, 2018
• Results First Posted: March 12, 2018

Record last verified: 2018-02

Locations

US (36)