Clinical trial NCT00934375: A 28-Week Open Label Extension Study Evaluating Safety and Tolerability of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment
Official title: A 28-Week Open Label Extension Study Evaluating Safety and Tolerability of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2009-07-08
Enrollment: 145
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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).

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events
timeFrame: Baseline, Week 6, Week 12 and Week 28.
Secondary outcomes:
Other outcomes:
Locations:
city: Alabaster
country: United States
facility: Neurology Neurodiagnostic Lab, LLC
state: Alabama
city: Peoria
country: United States
facility: Pivotal Research Centers
state: Arizona
city: Sun City
country: United States
facility: Sun Health Research Institute
state: Arizona
city: Tucson
country: United States
facility: Northwest Neurospecialists, PLLC
state: Arizona
city: Encinitas
country: United States
facility: The Neurology Center
state: California
city: Fresno
country: United States
facility: Margolin Brain Institute
state: California
city: Garden Grove
country: United States
facility: Colaborative Neuroscience Network (CNS Network)
state: California
city: Irvine
country: United States
facility: Nerve Pro Research
state: California
city: La Mesa
country: United States
facility: Optimum Health Services
state: California
city: San Diego
country: United States
facility: Pacific Research Network
state: California
city: Santa Monica
country: United States
facility: Neurological Research Institute
state: California
city: Sherman Oaks
country: United States
facility: CA Neuroscience Research
state: California
city: Vista
country: United States
facility: Pacific Research Network
state: California
city: New Haven
country: United States
facility: Yale University Alzheimers Disease Research Unit School of Medicine Department of Psychiatry
state: Connecticut
city: Deerfield Beach
country: United States
facility: North Broward Medical Center Memory Disorder Center
state: Florida
city: Ft. Lauderdale
country: United States
facility: Neurologic Consultants
state: Florida
city: Hialeah
country: United States
facility: Berma Research Group
state: Florida
city: Hollywood
country: United States
facility: Sunrise Clinical Research
state: Florida
city: Miami Beach
country: United States
facility: Wien Center for Memory Disorders, Mount Sinai Medical Center
state: Florida
city: Plantation
country: United States
facility: Berma Research Group
state: Florida
city: Sarasota
country: United States
facility: The Roskamp Institute
state: Florida
city: St. Petersburg
country: United States
facility: Comprehensive Neuroscience, Inc.
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials, LLC
state: Florida
city: Tampa
country: United States
facility: USF Memory Disorder's Clinic
state: Florida
city: Tampa
country: United States
facility: USF Suncoast Gerontalogy Center
state: Florida
city: Venice
country: United States
facility: Center for Clinical Trials. L.C.
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Neurology
state: Florida
city: Lexington
country: United States
facility: Lexington Clinic
state: Kentucky
city: Kalamazoo
country: United States
facility: Borgess Research Institute
state: Michigan
city: St. Louis
country: United States
facility: St. Louis University - Clinical Trials Unit
state: Missouri
city: Kenilworth
country: United States
facility: Comprehensive Neuroscience, Inc
state: New Jersey
city: Albany
country: United States
facility: Neurological Associates of Albany, PC Neurology
state: New York
city: Lawrence
country: United States
facility: Neurobehavioral Research Inc.
state: New York
city: New York
country: United States
facility: New York University School of Medicine Aging and Dementia Research Center
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Rochester
country: United States
facility: Monroe Community Hospital Program in Neurobehavioral Therapeutics
state: New York
city: Staten Island
country: United States
facility: Behavioral Medical Research of Staten Island
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Toledo
country: United States
facility: Neurology Center of Ohio
state: Ohio
city: Oklahoma City
country: United States
facility: Pahl Pharmaceutical Research, LLC
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network(Oregon) Inc.
state: Oregon
city: Bala Cynwyd
country: United States
facility: Clinical Trial Specialists
state: Pennsylvania
city: Greensburg
country: United States
facility: Westmoreland Neurology Associates
state: Pennsylvania
city: Jenkintown
country: United States
facility: The Clinical Trial Center, LLC
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina-Alzheimer's Research
state: South Carolina
city: Houston
country: United States
facility: The University of Texas Mental Sciences Instittute
state: Texas
city: San Antonio
country: United States
facility: START Center
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Clinical Drug Trials
state: Texas
city: Bennington
country: United States
facility: Southwestern Vermont Medical Center - The Memory Clinc
state: Vermont
Study officials:
affiliation: Eisai Inc.
name: Anita Murthy
role: STUDY_DIRECTOR
References: