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

Merck Sharp & Dohme (MSD)

Status and phase

Terminated

Phase 3

Conditions

Alzheimer Disease

Treatments

Drug: Investigational drug

Study type

Interventional

Funder types

Industry

Identifiers

NCT00006187

IA0025

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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