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Home > "T" Clinical Trials Conditions > The Safety and Efficacy of an Investigational Drug in Delaying the Progression of Alzheimer's Disease  The Safety and Efficacy of an Investigational Drug in Delaying the Progression of Alzheimer's Disease
The Safety and Efficacy of an Investigational Drug in Delaying the Progression of Alzheimer's Disease
For Condition: Alzheimer Disease
Status: Terminated
Sponsor(s): Merck ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 50 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KlausBeck, Principal Investigator, Merck
ICSL Clinical Studies
Sarasota, Florida, 34232
United States
California Clinical Trials
Beverly Hills, California, 90211
United States
Seattle Clinical Research Center
Seattle, Washington, 98104
United States
Pacific Research Network
San Diego, California, 92103
United States
Pivotal Research Centers
Peoria, Arizona, 85381
United States
Daniel Grosz MD
Northridge, California, 91324
United States
Yale University, Alzheimer's Disease ResearchUnit
New Haven, Connecticut, 06520-8037
United States
Pacific NW Clinical Research Center
Portland, Oregon, 97223
United States
Baumel-Eisner Neuromedical Institute
Boca Raton, Florida, 33486
United States
ICSL Clinical Studies
Providence, Rhode Island, 02915
United States
Baumel-Eisner Neuromedical Institute
Ft. Lauderdale, Florida, 33321
United States
Premiere Research Institute
West Palm Beach, Florida, 33407
United States
Institute for Advanced Clinical Research
Elkins Park, Pennsylvania, 19027
United States
New England Center for Headache
Stamford, Connecticut, 06902
United States
Pahl Brain Associates, P.C.
Oklahoma City, Oklahoma, 73118
United States
ICSL Clinical Studies
South Yarmouth, Massachusetts, 02664
United States
Pharmacology Research Institute
Newport Beach, California, 92660
United States
Palm Beach Neurological Center
West Palm Beach, Florida, 33410
United States
Piedmont Medical Research Associates
Winston Salem, North Carolina, 27103
United States
Clinical Pharmaceutical Trials
Tulsa, Oklahoma, 74104-5428
United States
Pharmacology Research Institute
Los Alamitos, California, 90720
United States
Nathan Klein Institute
Orangeburg, New York, 10962
United States
Meridien Research
St. Petersburg, Florida, 33710
United States
ICSL Clinical Studies
St. Petersburg, Florida, 33702
United States
San Francisco Headache Clinic
San Francisco, California, 94109
United States
Froedtert Lutheran Memorial Hospital
Milwaukee, Wisconsin, 53226
United States
ICSL Clinical Studies
Ft. Myers, Florida, 33907
United States
Pharmacology Research Clinic
Salt Lake City, Utah, 84107
United States
Pharmacology Research Institute
Riverside, California, 92506
United States
Las Vegas Center for Clinical Research
Las Vegas, Nevada, 89146
United States
ICSL Clinical Studies
Melbourne, Florida, 32935
United States
ICSL Clinical Studies
Philadelphia, Pennsylvania, 19106
United States
Chicago Center for Clinical Research
Chicago, Illinois, 60610
United States
University of Rochester
Rochester, New York, 14620
United States
Additional Information:
Study ID Numbers: IA0025;
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006187
Other Alzheimer Disease Studies:
1. Alzheimer's Disease Genetics Study
2. Valproate in Dementia (VALID)
3. Evaluation Of Three Doses of NS 2330 in Patients with Mild to Moderate Dementia of the Alzheimer’s Type
4. Study of Aripiprazole in the Treatment of Patients with Psychosis Associated with Dementia of the Alzheimer's Type
5. Antigonadotropin-Leuprolide in Alzheimer's Disease Drug INvestigation (ALADDIN) VP 104 Study
Related Studies:
Other Alzheimer Disease Clinical Trials
Other Arizona Clinical Trials
Other Peoria Clinical Trials
The Safety and Efficacy of an Investigational Drug in Delaying the Progression of Alzheimer's Disease
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