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

Alzheimer Disease Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00006187
• Other study ID #: IA0025
• Status: Terminated
• Phase: Phase 3
• First received: August 25, 2000
• Last updated: December 10, 2009
• Est. completion date: June 2005

Study information

• Verified date: October 2003
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• Investigational drug

Locations

Country	Name	City	State
United States	California Clinical Trials	Beverly Hills	California
United States	Baumel-Eisner Neuromedical Institute	Boca Raton	Florida
United States	Chicago Center for Clinical Research	Chicago	Illinois
United States	ICSL Clinical Studies	East Providence	Rhode Island
United States	Institute for Advanced Clinical Research	Elkins Park	Pennsylvania
United States	ICSL Clinical Studies	Fort Myers	Florida
United States	Baumel-Eisner Neuromedical Institute	Ft Lauderdale	Florida
United States	Las Vegas Center for Clinical Research	Las Vegas	Nevada
United States	Pharmacology Research Institute	Los Alamitos	California
United States	ICSL Clinical Studies	Melbourne	Florida
United States	Froedtert Lutheran Memorial Hospital	Milwaukee	Wisconsin
United States	Yale University, Alzheimer's Disease ResearchUnit	New Haven	Connecticut
United States	Pharmacology Research Institute	Newport Beach	California
United States	Daniel Grosz MD	Northridge	California
United States	Pahl Brain Associates, P.C.	Oklahoma City	Oklahoma
United States	Nathan Klein Institute	Orangeburg	New York
United States	Pivotal Research Centers	Peoria	Arizona
United States	ICSL Clinical Studies	Philadelphia	Pennsylvania
United States	Pacific NW Clinical Research Center	Portland	Oregon
United States	Pharmacology Research Institute	Riverside	California
United States	University of Rochester	Rochester	New York
United States	Pharmacology Research Clinic	Salt Lake City	Utah
United States	Pacific Research Network	San Diego	California
United States	San Francisco Headache Clinic	San Francisco	California
United States	ICSL Clinical Studies	Sarasota	Florida
United States	Seattle Clinical Research Center	Seattle	Washington
United States	ICSL Clinical Studies	South Yarmouth	Massachusetts
United States	ICSL Clinical Studies	St Petersburg	Florida
United States	Meridien Research	St Petersburg	Florida
United States	New England Center for Headache	Stamford	Connecticut
United States	Clinical Pharmaceutical Trials	Tulsa	Oklahoma
United States	Palm Beach Neurological Center	West Palm Beach	Florida
United States	Premiere Research Institute	West Palm Beach	Florida
United States	Piedmont Medical Research Associates	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States,