Study of MK0677 for the Treatment of Alzheimer's Disease

This study has been completed.

First Received: December 15, 2003 Last Updated: January 30, 2009 History of Changes

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00074529

Purpose

An investigational drug (MK0677) will be studied to determine whether it helps the memory and cognition of patients with Alzheimer's Disease.

Condition	Intervention	Phase
Alzheimer's Disease	Drug: MK0677	Phase II

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Ibutamoren mesylate

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Safety/Efficacy Study
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

Further study details as provided by Merck:

Primary Outcome Measures:

Cognitive function over 12 month period; safety and tolerability [ Time Frame: over 12 month period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	512
Study Start Date:	November 2003
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00074529

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_412, Formally-BG0812AZ, MK0677-030
Study First Received:	December 15, 2003
Last Updated:	January 30, 2009
ClinicalTrials.gov Identifier:	NCT00074529 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Disease Progression
Central Nervous System Diseases

Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on May 06, 2009