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

This study has been terminated.
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00006187
First received: August 25, 2000
Last updated: December 10, 2009
Last verified: October 2003

August 25, 2000
December 10, 2009
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June 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00006187 on ClinicalTrials.gov Archive Site
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The Safety and Efficacy of an Investigational Drug in Delaying the Progression of Alzheimer's Disease
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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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Alzheimer Disease
Drug: Investigational drug
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
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June 2005
June 2005   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006187
IA0025
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Merck Sharp & Dohme Corp.
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Principal Investigator: Klaus Beck, MD, PhD Merck Sharp & Dohme Corp.
National Institute on Aging (NIA)
October 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP