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

December 12, 2013 updated by: Eisai Inc.
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
145

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Alabaster, Alabama, United States, 35007
        • Neurology Neurodiagnostic Lab, LLC
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Pivotal Research Centers
      • Sun City, Arizona, United States, 85351
        • Sun Health Research Institute
      • Tucson, Arizona, United States, 85741-3537
        • Northwest NeuroSpecialists, PLLC
    • California
      • Encinitas, California, United States, 92024
        • The Neurology Center
      • Fresno, California, United States, 93720
        • Margolin Brain Institute
      • Garden Grove, California, United States, 92845
        • Colaborative Neuroscience Network (CNS Network)
      • Irvine, California, United States, 92618
        • Nerve Pro Research
      • La Mesa, California, United States, 91942
        • Optimum Health Services
      • San Diego, California, United States, 92103
        • Pacific Research Network
      • Santa Monica, California, United States, 90404
        • Neurological Research Institute
      • Sherman Oaks, California, United States, 91403
        • CA Neuroscience Research
      • Vista, California, United States, 92081
        • Pacific Research Network
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University Alzheimers Disease Research Unit School of Medicine Department of Psychiatry
    • Florida
      • Deerfield Beach, Florida, United States, 33064
        • North Broward Medical Center Memory Disorder Center
      • Ft. Lauderdale, Florida, United States, 33308
        • Neurologic Consultants
      • Hialeah, Florida, United States, 33016
        • Berma Research Group
      • Hollywood, Florida, United States, 33021
        • Sunrise Clinical Research
      • Miami Beach, Florida, United States, 33140
        • Wien Center for Memory Disorders, Mount Sinai Medical Center
      • Plantation, Florida, United States, 33317
        • Berma Research Group
      • Sarasota, Florida, United States, 34243
        • The Roskamp Institute
      • St. Petersburg, Florida, United States, 33702
        • Comprehensive NeuroScience, Inc.
      • Tampa, Florida, United States, 33613
        • Stedman Clinical Trials, LLC
      • Tampa, Florida, United States, 33613
        • USF Memory Disorder's Clinic
      • Tampa, Florida, United States, 33617
        • USF Suncoast Gerontalogy Center
      • Venice, Florida, United States, 34285
        • Center for Clinical Trials. L.C.
      • West Palm Beach, Florida, United States, 33407
        • Palm Beach Neurology
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Lexington Clinic
    • Michigan
      • Kalamazoo, Michigan, United States, 49048
        • Borgess Research Institute
    • Missouri
      • St. Louis, Missouri, United States, 63104
        • St. Louis University - Clinical Trials Unit
    • New Jersey
      • Kenilworth, New Jersey, United States, 07033
        • Comprehensive Neuroscience, Inc
    • New York
      • Albany, New York, United States, 12208
        • Neurological Associates of Albany, PC Neurology
      • Lawrence, New York, United States, 11559
        • Neurobehavioral Research Inc.
      • New York, New York, United States, 10032
        • Columbia University
      • New York, New York, United States, 10016
        • New York University School of Medicine Aging and Dementia Research Center
      • Rochester, New York, United States, 14620
        • Monroe Community Hospital Program in Neurobehavioral Therapeutics
      • Staten Island, New York, United States, 10305
        • Behavioral Medical Research Of Staten Island
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
      • Toledo, Ohio, United States, 43623
        • Neurology Center Of Ohio
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73118
        • Pahl Pharmaceutical Research, LLC
    • Oregon
      • Portland, Oregon, United States, 97210
        • Summit Research Network(Oregon) Inc.
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, United States, 19004
        • Clinical Trial Specialists
      • Greensburg, Pennsylvania, United States, 15601
        • Westmoreland Neurology Associates
      • Jenkintown, Pennsylvania, United States, 19046
        • The Clinical Trial Center, LLC
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Medical University of South Carolina-Alzheimer's Research
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Mental Sciences Instittute
      • San Antonio, Texas, United States, 78229-3900
        • START Center
      • Wichita Falls, Texas, United States, 76309
        • Grayline Clinical Drug Trials
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Southwestern Vermont Medical Center - The Memory Clinc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
Drug: Aricept (donepezil hydrochloride)
5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.
Other Names:
  • donepezil hydrochloride
Placebo Comparator: 2
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events
Time Frame: Baseline, Week 6, Week 12 and Week 28.
Overview of Treatment-Emergent Adverse Events and Safety Population (TEAEs)
Baseline, Week 6, Week 12 and Week 28.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eisai Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Anita Murthy, Eisai Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E2020-A001-414

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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