The Safety and Efficacy of an Investigational Drug in Delaying the Progression of Alzheimer's Disease

December 10, 2009 updated by: Merck Sharp & Dohme LLC
This is a 15-month study with two phases. During the first 12-month phase of this study, patients will be randomly assigned to receive either active study drug or placebo (approximately half of all patients will be on active study drug, the other half on placebo). The second phase is a 3-month randomized withdrawal period. For this phase approximately 10% of the patients will remain on the active drug.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a placebo-controlled, parallel-groups, 12 month, double-blind study, followed by a 3-month, double-blind, randomized withdrawal period to evaluate the efficacy and safety of an investigational drug (currently approved for other indications) to slow the progression of symptoms of AD. Patients with probable AD according to NINCDS-ADRDA criteria who have a Mini Mental State Examination (MMSE) score between 13 and 26 inclusive will be eligible for participation in the study.

Patients on stable doses of marketed cholinesterase inhibitors approved for the treatment of AD (except for tacrine) for at least 3 months are eligible for study entry. Use of NSAIDs (except aspirin 81 mg per day) is not allowed during the study.

Study Type

Interventional

Phase

  • Phase 3

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
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Pivotal Research Centers
    • California
      • Beverly Hills, California, United States, 90211
        • California Clinical Trials
      • Los Alamitos, California, United States, 90720
        • Pharmacology Research Institute
      • Newport Beach, California, United States, 92660
        • Pharmacology Research Institute
      • Northridge, California, United States, 91324
        • Daniel Grosz MD
      • Riverside, California, United States, 92506
        • Pharmacology Research Institute
      • San Diego, California, United States, 92103
        • Pacific Research Network
      • San Francisco, California, United States, 94109
        • San Francisco Headache Clinic
    • Connecticut
      • New Haven, Connecticut, United States, 06520-8037
        • Yale University, Alzheimer's Disease ResearchUnit
      • Stamford, Connecticut, United States, 06902
        • New England Center for Headache
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Baumel-Eisner Neuromedical Institute
      • Fort Myers, Florida, United States, 33907
        • ICSL Clinical Studies
      • Ft Lauderdale, Florida, United States, 33321
        • Baumel-Eisner Neuromedical Institute
      • Melbourne, Florida, United States, 32935
        • ICSL Clinical Studies
      • Sarasota, Florida, United States, 34232
        • ICSL Clinical Studies
      • St Petersburg, Florida, United States, 33702
        • ICSL Clinical Studies
      • St Petersburg, Florida, United States, 33710
        • Meridien Research
      • West Palm Beach, Florida, United States, 33407
        • Premiere Research Institute
      • West Palm Beach, Florida, United States, 33410
        • Palm Beach Neurological Center
    • Illinois
      • Chicago, Illinois, United States, 60610
        • Chicago Center for Clinical Research
    • Massachusetts
      • South Yarmouth, Massachusetts, United States, 02664
        • ICSL Clinical Studies
    • Nevada
      • Las Vegas, Nevada, United States, 89146
        • Las Vegas Center for Clinical Research
    • New York
      • Orangeburg, New York, United States, 10962
        • Nathan Klein Institute
      • Rochester, New York, United States, 14620
        • University of Rochester
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Piedmont Medical Research Associates
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73118
        • Pahl Brain Associates, P.C.
      • Tulsa, Oklahoma, United States, 74104-5428
        • Clinical Pharmaceutical Trials
    • Oregon
      • Portland, Oregon, United States, 97223
        • Pacific NW Clinical Research Center
    • Pennsylvania
      • Elkins Park, Pennsylvania, United States, 19027
        • Institute for Advanced Clinical Research
      • Philadelphia, Pennsylvania, United States, 19106
        • ICSL Clinical Studies
    • Rhode Island
      • East Providence, Rhode Island, United States, 02915
        • ICSL Clinical Studies
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Pharmacology Research Clinic
    • Washington
      • Seattle, Washington, United States, 98104
        • Seattle Clinical Research Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Lutheran Memorial Hospital

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

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient is male or female and at least 50 years of age or older
  • Female patients must be postmenopausal or surgically sterilized
  • Clinical diagnosis of AD
  • Patient must be in good health except for AD diagnosis
  • Patient must have informant/caregiver who can monitor and assist patient during the study

Exclusion Criteria:

  • Patient is living in a nursing home or skilled nursing facility
  • Women will be ineligible if not postmenopausal or surgically sterilized
  • Site physician or Sponsor may exclude patients with serious medical problems such as cancer, cardiovascular disease, major neurological or psychiatric illness, thyroid disease, or major head trauma

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: Double

Collaborators and Investigators

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

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Klaus Beck, MD, PhD, Merck Sharp & Dohme LLC

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

Primary Completion (Anticipated)

June 1, 2005

Study Completion (Anticipated)

June 1, 2005

Study Registration Dates

First Submitted

August 25, 2000

First Submitted That Met QC Criteria

August 25, 2000

First Posted (Estimate)

August 28, 2000

Study Record Updates

Last Update Posted (Estimate)

December 11, 2009

Last Update Submitted That Met QC Criteria

December 10, 2009

Last Verified

October 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IA0025

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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