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

This study has been terminated.
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00006187
First received: August 25, 2000
Last updated: December 10, 2009
Last verified: October 2003
  Purpose

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.


Condition Intervention Phase
Alzheimer Disease
Drug: Investigational drug
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Estimated Study Completion Date: June 2005
Estimated Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006187

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

No publications provided

ClinicalTrials.gov Identifier: NCT00006187     History of Changes
Other Study ID Numbers: IA0025
Study First Received: August 25, 2000
Last Updated: December 10, 2009
Health Authority: Unspecified

Keywords provided by National Institute on Aging (NIA):
Investigational Drug

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014