Back to resultsStudy of MK0677 for the Treatment of Alzheimer's Disease (0677-030)(COMPLETED)
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0677
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
Patients must have probable Alzheimer's disease of mild or moderate severity. A brain scan and laboratory results must be consistent with Alzheimer's disease. The patient must be otherwise medically healthy.
Sites / Locations
Outcomes
Primary Outcome Measures
Cognitive function over 12 month period; safety and tolerability
Secondary Outcome Measures
AD symptoms over a 6 month and 12 month period measured by the CIBIC + and the ADAS-Cog.
Full Information
NCT ID
NCT00074529
First Posted
December 15, 2003
Last Updated
July 23, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00074529
Brief Title
Study of MK0677 for the Treatment of Alzheimer's Disease (0677-030)(COMPLETED)
Official Title
A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of MK-0677 25 mg in Slowing the Progression of Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
An investigational drug (MK0677) will be studied to determine whether it helps the memory and cognition of patients with Alzheimer's Disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
512 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0677
Primary Outcome Measure Information:
Title
Cognitive function over 12 month period; safety and tolerability
Time Frame
over 12 month period
Secondary Outcome Measure Information:
Title
AD symptoms over a 6 month and 12 month period measured by the CIBIC + and the ADAS-Cog.
Time Frame
over a 6 month and 12 month period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients must have probable Alzheimer's disease of mild or moderate severity.
A brain scan and laboratory results must be consistent with Alzheimer's disease.
The patient must be otherwise medically healthy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
19015485
Citation
Sevigny JJ, Ryan JM, van Dyck CH, Peng Y, Lines CR, Nessly ML; MK-677 Protocol 30 Study Group. Growth hormone secretagogue MK-677: no clinical effect on AD progression in a randomized trial. Neurology. 2008 Nov 18;71(21):1702-8. doi: 10.1212/01.wnl.0000335163.88054.e7.
Results Reference
background
PubMed Identifier
19949163
Citation
Sevigny JJ, Peng Y, Liu L, Lines CR. Item analysis of ADAS-Cog: effect of baseline cognitive impairment in a clinical AD trial. Am J Alzheimers Dis Other Demen. 2010 Mar;25(2):119-24. doi: 10.1177/1533317509350298.
Results Reference
derived
Learn more about this trial
Study of MK0677 for the Treatment of Alzheimer's Disease (0677-030)(COMPLETED)
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