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

• Status: Terminated
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

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