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

Stopped early · Phase 3

Conditions studied: Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT00006187

Run by

Merck Sharp & Dohme LLC

Expected to finish

2005-06-01

Last updated by the study team

2009-12-11

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Pivotal Research Centers — Peoria, Arizona, United States
• California Clinical Trials — Beverly Hills, California, United States
• Pharmacology Research Institute — Los Alamitos, California, United States
• Pharmacology Research Institute — Newport Beach, California, United States
• Daniel Grosz MD — Northridge, California, United States
• Pharmacology Research Institute — Riverside, California, United States
• Pacific Research Network — San Diego, California, United States
• San Francisco Headache Clinic — San Francisco, California, United States
• Yale University, Alzheimer's Disease ResearchUnit — New Haven, Connecticut, United States
• New England Center for Headache — Stamford, Connecticut, United States
• Baumel-Eisner Neuromedical Institute — Boca Raton, Florida, United States
• Baumel-Eisner Neuromedical Institute — Fort Lauderdale, Florida, United States
• ICSL Clinical Studies — Fort Myers, Florida, United States
• ICSL Clinical Studies — Melbourne, Florida, United States
• ICSL Clinical Studies — Sarasota, Florida, United States
• ICSL Clinical Studies — St. Petersburg, Florida, United States
• Meridien Research — St. Petersburg, Florida, United States
• Premiere Research Institute — West Palm Beach, Florida, United States
• Palm Beach Neurological Center — West Palm Beach, Florida, United States
• Chicago Center for Clinical Research — Chicago, Illinois, United States
• ICSL Clinical Studies — South Yarmouth, Massachusetts, United States
• Las Vegas Center for Clinical Research — Las Vegas, Nevada, United States
• Nathan Klein Institute — Orangeburg, New York, United States
• University of Rochester — Rochester, New York, United States
• Piedmont Medical Research Associates — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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