A 28-Week Open Label Extension Study Evaluating Safety and Tolerability of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

Official title:

A 28-Week Open Label Extension Study Evaluating Safety and Tolerability of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00934375
• Other study ID #: E2020-A001-414
• Status: Completed
• Phase: Phase 4
• First received: May 14, 2009
• Last updated: December 12, 2013
• Start date: February 2006
• Est. completion date: September 2007

Study information

• Verified date: December 2013
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a multi-center, open-label study of 28 weeks duration in subjects with Mild Cognitive Impairment who have completed the double-blind study (E2020-A001-412).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Gender: Both
• Age group: 45 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Age Range: Adult subjects (45 to 90 years of age inclusive)

2. Sex distribution: Men and women. Women of child-bearing potential (<1 year post menopausal) must be practicing effective contraception and have negative serum B-HCG at Screening. [Women who are breast-feeding are excluded.]

3. Subjects must have completed the one year, double-blind core trial (E2020-A001-412).

4. A completed Diagnostic Worksheet at the end of the double-blind core trial (E2020-A001-412) indicating no conversion to Alzheimer's Disease or dementia.

5. Health: Generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane).

6. The subject must be expected to complete the entire study.

7. Subjects must be sufficiently fluent in English.

8. Subjects must have an informant who has daily contact with the subject (e.g., an average of 10 or more hours per week), can observe for possible adverse events and will accompany the subject to all visits.

9. Clinical laboratory values must be within normal limits, or if abnormal, judged clinically insignificant by the investigator (not likely to cause cognitive impairment or medical instability).

Exclusion Criteria:

1. Subjects who have not completed or have terminated early from the one year, double-blind core trial (E2020-A001-412).

2. Any subject without a completed diagnostic worksheet from Week 51 of the core double-blind trial (E2020-A001-412).

3. Any subject with a completed diagnostic worksheet from Week 51 of the core double-blind trial (E2020-A001-412) indicating conversion to Alzheimer's or other dementia.

4. Subjects with uncontrolled hypertension (sitting systolic >= 160mmHg and/or diastolic >=95mmHg) as assessed by the investigator, regardless of whether or not the subject is taking anti-hypertensive medications.

5. Subjects with a history of malignant neoplasms treated within five years prior to study entry (other than basal or squamous cell carcinoma of the skin); current evidence of malignant neoplasm; or recurrent or matastatic disease.

6. Subjects who have suffered a severe infection or a major surgical procedure within three months prior to baseline.

7. Subjects who may not be able to comply with the protocol.

8. Subjects with known hypersensitivity to piperidine derivatives or acetylcholinesterase(AChE)inhibitors.

9. Subjects with diabetes mellitis not controlled by diet and/or medication with a random serum glucose value of >170mg/dl.

10. Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study.

11. Subjects who do not have a reliable informant (e.g., the informant has contact with the subject less than 10 hours per week).

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Drug:
• Aricept (donepezil hydrochloride)
5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.
• placebo

Locations

Country	Name	City	State
United States	Neurology Neurodiagnostic Lab, LLC	Alabaster	Alabama
United States	Neurological Associates of Albany, PC Neurology	Albany	New York
United States	Clinical Trial Specialists	Bala Cynwyd	Pennsylvania
United States	Southwestern Vermont Medical Center - The Memory Clinc	Bennington	Vermont
United States	Medical University of South Carolina-Alzheimer's Research	Charleston	South Carolina
United States	The Ohio State University	Columbus	Ohio
United States	North Broward Medical Center Memory Disorder Center	Deerfield Beach	Florida
United States	The Neurology Center	Encinitas	California
United States	Margolin Brain Institute	Fresno	California
United States	Neurologic Consultants	Ft. Lauderdale	Florida
United States	Colaborative Neuroscience Network (CNS Network)	Garden Grove	California
United States	Westmoreland Neurology Associates	Greensburg	Pennsylvania
United States	Berma Research Group	Hialeah	Florida
United States	Sunrise Clinical Research	Hollywood	Florida
United States	The University of Texas Mental Sciences Instittute	Houston	Texas
United States	Nerve Pro Research	Irvine	California
United States	The Clinical Trial Center, LLC	Jenkintown	Pennsylvania
United States	Borgess Research Institute	Kalamazoo	Michigan
United States	Comprehensive Neuroscience, Inc	Kenilworth	New Jersey
United States	Optimum Health Services	La Mesa	California
United States	Neurobehavioral Research Inc.	Lawrence	New York
United States	Lexington Clinic	Lexington	Kentucky
United States	Wien Center for Memory Disorders, Mount Sinai Medical Center	Miami Beach	Florida
United States	Yale University Alzheimers Disease Research Unit School of Medicine Department of Psychiatry	New Haven	Connecticut
United States	Columbia University	New York	New York
United States	New York University School of Medicine Aging and Dementia Research Center	New York	New York
United States	Pahl Pharmaceutical Research, LLC	Oklahoma City	Oklahoma
United States	Pivotal Research Centers	Peoria	Arizona
United States	Berma Research Group	Plantation	Florida
United States	Summit Research Network(Oregon) Inc.	Portland	Oregon
United States	Monroe Community Hospital Program in Neurobehavioral Therapeutics	Rochester	New York
United States	START Center	San Antonio	Texas
United States	Pacific Research Network	San Diego	California
United States	Neurological Research Institute	Santa Monica	California
United States	The Roskamp Institute	Sarasota	Florida
United States	CA Neuroscience Research	Sherman Oaks	California
United States	St. Louis University - Clinical Trials Unit	St. Louis	Missouri
United States	Comprehensive Neuroscience, Inc.	St. Petersburg	Florida
United States	Behavioral Medical Research of Staten Island	Staten Island	New York
United States	Sun Health Research Institute	Sun City	Arizona
United States	Stedman Clinical Trials, LLC	Tampa	Florida
United States	USF Memory Disorder's Clinic	Tampa	Florida
United States	USF Suncoast Gerontalogy Center	Tampa	Florida
United States	Neurology Center of Ohio	Toledo	Ohio
United States	Northwest Neurospecialists, PLLC	Tucson	Arizona
United States	Center for Clinical Trials. L.C.	Venice	Florida
United States	Pacific Research Network	Vista	California
United States	Palm Beach Neurology	West Palm Beach	Florida
United States	Grayline Clinical Drug Trials	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Emergent Adverse Events	Overview of Treatment-Emergent Adverse Events and Safety Population (TEAEs)	Baseline, Week 6, Week 12 and Week 28.	Yes