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

NCT ID: NCT00006187

Last Updated: 2009-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Completion Date

2005-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Alzheimer Disease

Keywords

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Investigational Drug

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Investigational drug

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Principal Investigators

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Klaus Beck, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Merck Sharp & Dohme LLC

Locations

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Pivotal Research Centers

Peoria, Arizona, United States

Site Status

California Clinical Trials

Beverly Hills, California, United States

Site Status

Pharmacology Research Institute

Los Alamitos, California, United States

Site Status

Pharmacology Research Institute

Newport Beach, California, United States

Site Status

Daniel Grosz MD

Northridge, California, United States

Site Status

Pharmacology Research Institute

Riverside, California, United States

Site Status

Pacific Research Network

San Diego, California, United States

Site Status

San Francisco Headache Clinic

San Francisco, California, United States

Site Status

Yale University, Alzheimer's Disease ResearchUnit

New Haven, Connecticut, United States

Site Status

New England Center for Headache

Stamford, Connecticut, United States

Site Status

Baumel-Eisner Neuromedical Institute

Boca Raton, Florida, United States

Site Status

Baumel-Eisner Neuromedical Institute

Fort Lauderdale, Florida, United States

Site Status

ICSL Clinical Studies

Fort Myers, Florida, United States

Site Status

ICSL Clinical Studies

Melbourne, Florida, United States

Site Status

ICSL Clinical Studies

Sarasota, Florida, United States

Site Status

ICSL Clinical Studies

St. Petersburg, Florida, United States

Site Status

Meridien Research

St. Petersburg, Florida, United States

Site Status

Premiere Research Institute

West Palm Beach, Florida, United States

Site Status

Palm Beach Neurological Center

West Palm Beach, Florida, United States

Site Status

Chicago Center for Clinical Research

Chicago, Illinois, United States

Site Status

ICSL Clinical Studies

South Yarmouth, Massachusetts, United States

Site Status

Las Vegas Center for Clinical Research

Las Vegas, Nevada, United States

Site Status

Nathan Klein Institute

Orangeburg, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

Piedmont Medical Research Associates

Winston-Salem, North Carolina, United States

Site Status

Pahl Brain Associates, P.C.

Oklahoma City, Oklahoma, United States

Site Status

Clinical Pharmaceutical Trials

Tulsa, Oklahoma, United States

Site Status

Pacific NW Clinical Research Center

Portland, Oregon, United States

Site Status

Institute for Advanced Clinical Research

Elkins Park, Pennsylvania, United States

Site Status

ICSL Clinical Studies

Philadelphia, Pennsylvania, United States

Site Status

ICSL Clinical Studies

East Providence, Rhode Island, United States

Site Status

Pharmacology Research Clinic

Salt Lake City, Utah, United States

Site Status

Seattle Clinical Research Center

Seattle, Washington, United States

Site Status

Froedtert Lutheran Memorial Hospital

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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IA0025

Identifier Type: -

Identifier Source: org_study_id