The Safety and Efficacy of an Investigational Drug in Delaying the Progression of Alzheimer's Disease
- Conditions
- Alzheimer Disease
- Registration Number
- NCT00006187
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
Pacific NW Clinical Research Center
🇺🇸Portland, Oregon, United States
University of Rochester
🇺🇸Rochester, New York, United States
Piedmont Medical Research Associates
🇺🇸Winston-Salem, North Carolina, United States
Clinical Pharmaceutical Trials
🇺🇸Tulsa, Oklahoma, United States
Nathan Klein Institute
🇺🇸Orangeburg, New York, United States
Froedtert Lutheran Memorial Hospital
🇺🇸Milwaukee, Wisconsin, United States
Institute for Advanced Clinical Research
🇺🇸Elkins Park, Pennsylvania, United States
New England Center for Headache
🇺🇸Stamford, Connecticut, United States
Pacific Research Network
🇺🇸San Diego, California, United States
Chicago Center for Clinical Research
🇺🇸Chicago, Illinois, United States
Las Vegas Center for Clinical Research
🇺🇸Las Vegas, Nevada, United States
Pahl Brain Associates, P.C.
🇺🇸Oklahoma City, Oklahoma, United States
Pharmacology Research Clinic
🇺🇸Salt Lake City, Utah, United States
Seattle Clinical Research Center
🇺🇸Seattle, Washington, United States
California Clinical Trials
🇺🇸Beverly Hills, California, United States
Pharmacology Research Institute
🇺🇸Riverside, California, United States
Pivotal Research Centers
🇺🇸Peoria, Arizona, United States
Daniel Grosz MD
🇺🇸Northridge, California, United States
San Francisco Headache Clinic
🇺🇸San Francisco, California, United States
Baumel-Eisner Neuromedical Institute
🇺🇸Ft Lauderdale, Florida, United States
Palm Beach Neurological Center
🇺🇸West Palm Beach, Florida, United States
Yale University, Alzheimer's Disease ResearchUnit
🇺🇸New Haven, Connecticut, United States
ICSL Clinical Studies
🇺🇸East Providence, Rhode Island, United States
Meridien Research
🇺🇸St Petersburg, Florida, United States
Premiere Research Institute
🇺🇸West Palm Beach, Florida, United States