The Safety and Efficacy of an Investigational Drug in Delaying the Progression of Alzheimer's Disease
1 other identifier
interventional
N/A
1 country
34
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
34 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2000
CompletedFirst Posted
Study publicly available on registry
August 28, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedDecember 11, 2009
October 1, 2003
August 25, 2000
December 10, 2009
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Pivotal Research Centers
Peoria, Arizona, 85381, United States
California Clinical Trials
Beverly Hills, California, 90211, United States
Pharmacology Research Institute
Los Alamitos, California, 90720, United States
Pharmacology Research Institute
Newport Beach, California, 92660, United States
Daniel Grosz MD
Northridge, California, 91324, United States
Pharmacology Research Institute
Riverside, California, 92506, United States
Pacific Research Network
San Diego, California, 92103, United States
San Francisco Headache Clinic
San Francisco, California, 94109, United States
Yale University, Alzheimer's Disease ResearchUnit
New Haven, Connecticut, 06520-8037, United States
New England Center for Headache
Stamford, Connecticut, 06902, United States
Baumel-Eisner Neuromedical Institute
Boca Raton, Florida, 33486, United States
Baumel-Eisner Neuromedical Institute
Fort Lauderdale, Florida, 33321, United States
ICSL Clinical Studies
Fort Myers, Florida, 33907, United States
ICSL Clinical Studies
Melbourne, Florida, 32935, United States
ICSL Clinical Studies
Sarasota, Florida, 34232, United States
ICSL Clinical Studies
St. Petersburg, Florida, 33702, United States
Meridien Research
St. Petersburg, Florida, 33710, United States
Premiere Research Institute
West Palm Beach, Florida, 33407, United States
Palm Beach Neurological Center
West Palm Beach, Florida, 33410, United States
Chicago Center for Clinical Research
Chicago, Illinois, 60610, United States
ICSL Clinical Studies
South Yarmouth, Massachusetts, 02664, United States
Las Vegas Center for Clinical Research
Las Vegas, Nevada, 89146, United States
Nathan Klein Institute
Orangeburg, New York, 10962, United States
University of Rochester
Rochester, New York, 14620, United States
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103, United States
Pahl Brain Associates, P.C.
Oklahoma City, Oklahoma, 73118, United States
Clinical Pharmaceutical Trials
Tulsa, Oklahoma, 74104-5428, United States
Pacific NW Clinical Research Center
Portland, Oregon, 97223, United States
Institute for Advanced Clinical Research
Elkins Park, Pennsylvania, 19027, United States
ICSL Clinical Studies
Philadelphia, Pennsylvania, 19106, United States
ICSL Clinical Studies
East Providence, Rhode Island, 02915, United States
Pharmacology Research Clinic
Salt Lake City, Utah, 84107, United States
Seattle Clinical Research Center
Seattle, Washington, 98104, United States
Froedtert Lutheran Memorial Hospital
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Klaus Beck, MD, PhD
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 25, 2000
First Posted
August 28, 2000
Primary Completion
June 1, 2005
Study Completion
June 1, 2005
Last Updated
December 11, 2009
Record last verified: 2003-10