Clinical trial NCT00006187: The Safety and Efficacy of an Investigational Drug in Delaying the Progression of Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Alzheimer Disease
Keywords: Investigational Drug
Lead sponsor: National Institute on Aging (NIA)
Sponsor class: NIH
First posted: 2000-08-28
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

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