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| Sponsor: | Merck |
|---|---|
| Information provided by: | National Institute on Aging (NIA) |
| ClinicalTrials.gov Identifier: | NCT00006187 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Estimated Study Completion Date: | March 2001 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Pivotal Research Centers | |
| Peoria, Arizona, United States, 85381 | |
| United States, California | |
| California Clinical Trials | |
| Beverly Hills, California, United States, 90211 | |
| Daniel Grosz MD | |
| Northridge, California, United States, 91324 | |
| Pacific Research Network | |
| San Diego, California, United States, 92103 | |
| San Francisco Headache Clinic | |
| San Francisco, California, United States, 94109 | |
| Pharmacology Research Institute | |
| Riverside, California, United States, 92506 | |
| Pharmacology Research Institute | |
| Newport Beach, California, United States, 92660 | |
| Pharmacology Research Institute | |
| Los Alamitos, California, United States, 90720 | |
| United States, Connecticut | |
| New England Center for Headache | |
| Stamford, Connecticut, United States, 06902 | |
| Yale University, Alzheimer's Disease ResearchUnit | |
| New Haven, Connecticut, United States, 06520-8037 | |
| United States, Florida | |
| Baumel-Eisner Neuromedical Institute | |
| Ft. Lauderdale, Florida, United States, 33321 | |
| Baumel-Eisner Neuromedical Institute | |
| Boca Raton, Florida, United States, 33486 | |
| ICSL Clinical Studies | |
| Sarasota, Florida, United States, 34232 | |
| Meridien Research | |
| St. Petersburg, Florida, United States, 33710 | |
| ICSL Clinical Studies | |
| Melbourne, Florida, United States, 32935 | |
| ICSL Clinical Studies | |
| Fort Myers, Florida, United States, 33907 | |
| 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 | |
| University of Rochester | |
| Rochester, New York, United States, 14620 | |
| Nathan Klein Institute | |
| Orangeburg, New York, United States, 10962 | |
| United States, North Carolina | |
| Piedmont Medical Research Associates | |
| Winston Salem, North Carolina, United States, 27103 | |
| United States, Oklahoma | |
| Clinical Pharmaceutical Trials | |
| Tulsa, Oklahoma, United States, 74104-5428 | |
| Pahl Brain Associates, P.C. | |
| Oklahoma City, Oklahoma, United States, 73118 | |
| United States, Oregon | |
| Pacific NW Clinical Research Center | |
| Portland, Oregon, United States, 97223 | |
| United States, Pennsylvania | |
| ICSL Clinical Studies | |
| Philadelphia, Pennsylvania, United States, 19106 | |
| Institute for Advanced Clinical Research | |
| Elkins Park, Pennsylvania, United States, 19027 | |
| 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 | |
| Principal Investigator: | Klaus Beck, MD, PhD | Merck |
More Information
| Study ID Numbers: | IA0025 |
| Study First Received: | August 25, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00006187 History of Changes |
| Health Authority: | Unspecified |
|
Investigational Drug |
|
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Nervous System Diseases Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Tauopathies Brain Diseases Dementia |
