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

Primary Purpose

Alzheimer Disease

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Investigational drug
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Investigational Drug

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Pivotal Research Centers
  • California Clinical Trials
  • Pharmacology Research Institute
  • Pharmacology Research Institute
  • Daniel Grosz MD
  • Pharmacology Research Institute
  • Pacific Research Network
  • San Francisco Headache Clinic
  • Yale University, Alzheimer's Disease ResearchUnit
  • New England Center for Headache
  • Baumel-Eisner Neuromedical Institute
  • ICSL Clinical Studies
  • Baumel-Eisner Neuromedical Institute
  • ICSL Clinical Studies
  • ICSL Clinical Studies
  • ICSL Clinical Studies
  • Meridien Research
  • Premiere Research Institute
  • Palm Beach Neurological Center
  • Chicago Center for Clinical Research
  • ICSL Clinical Studies
  • Las Vegas Center for Clinical Research
  • Nathan Klein Institute
  • University of Rochester
  • Piedmont Medical Research Associates
  • Pahl Brain Associates, P.C.
  • Clinical Pharmaceutical Trials
  • Pacific NW Clinical Research Center
  • Institute for Advanced Clinical Research
  • ICSL Clinical Studies
  • ICSL Clinical Studies
  • Pharmacology Research Clinic
  • Seattle Clinical Research Center
  • Froedtert Lutheran Memorial Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 25, 2000
Last Updated
December 10, 2009
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00006187
Brief Title
The Safety and Efficacy of an Investigational Drug in Delaying the Progression of Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2003
Overall Recruitment Status
Terminated
Study Start Date
undefined (undefined)
Primary Completion Date
June 2005 (Anticipated)
Study Completion Date
June 2005 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Investigational Drug

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Investigational drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Beck, MD, PhD
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pivotal Research Centers
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
California Clinical Trials
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Pharmacology Research Institute
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Pharmacology Research Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Daniel Grosz MD
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Pharmacology Research Institute
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Pacific Research Network
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
San Francisco Headache Clinic
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Yale University, Alzheimer's Disease ResearchUnit
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8037
Country
United States
Facility Name
New England Center for Headache
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
Baumel-Eisner Neuromedical Institute
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
ICSL Clinical Studies
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Facility Name
Baumel-Eisner Neuromedical Institute
City
Ft Lauderdale
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
ICSL Clinical Studies
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32935
Country
United States
Facility Name
ICSL Clinical Studies
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
ICSL Clinical Studies
City
St Petersburg
State/Province
Florida
ZIP/Postal Code
33702
Country
United States
Facility Name
Meridien Research
City
St Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
Premiere Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Palm Beach Neurological Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Chicago Center for Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
ICSL Clinical Studies
City
South Yarmouth
State/Province
Massachusetts
ZIP/Postal Code
02664
Country
United States
Facility Name
Las Vegas Center for Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89146
Country
United States
Facility Name
Nathan Klein Institute
City
Orangeburg
State/Province
New York
ZIP/Postal Code
10962
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Piedmont Medical Research Associates
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Pahl Brain Associates, P.C.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
Clinical Pharmaceutical Trials
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104-5428
Country
United States
Facility Name
Pacific NW Clinical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Institute for Advanced Clinical Research
City
Elkins Park
State/Province
Pennsylvania
ZIP/Postal Code
19027
Country
United States
Facility Name
ICSL Clinical Studies
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
ICSL Clinical Studies
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02915
Country
United States
Facility Name
Pharmacology Research Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Seattle Clinical Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Froedtert Lutheran Memorial Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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