MK0249 for the Symptomatic Treatment of Alzheimer's Disease - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00420420

Purpose

The purpose of this study is to test the efficacy and safety of an investigational medication for improving symptoms of Alzheimer's Disease. Subjects will receive either active medication or placebo for 28 days. Tests of memory, concentration will be included. Safety will be monitored using routine clinical and laboratory tests.

Condition	Intervention	Phase
Alzheimer's Disease	Drug: MK0249 Drug: Comparator: Placebo (unspecified)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety and Efficacy of MK0249 for the Symptomatic Treatment of Alzheimer's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

computerized test battery and ADAS-Cog [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

composite cognition score [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

Enrollment:	150
Study Start Date:	October 2006
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MK0249	Drug: MK0249 MK0249 5mg tablet qd for 28 day treatment period.
2: Placebo Comparator placebo	Drug: Comparator: Placebo (unspecified) MK0249 5mg Pbo tablet qd for a 28 day treatment period

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or females
Age at least 55 years or older
Mild-to-moderate Alzheimer's Disease, with MMSE between 18 and 26, inclusive, MHIS score at least 4, Global CDR score of 1 or 2, and who have a reliable informant/caregiver to accompany patient to all clinic visits
If using symptomatic Alzheimer's Disease treatments, patients must be on the medication for 3 months and on a STABLE DOSE for at least 2 months

Exclusion Criteria:

Patients cannot be living in a skilled nursing facility
Patients cannot have poorly-controlled hypertension
Patients cannot have the following conditions within 6 months of screening: significant cardiovascular disorders, active major depressive disorder, gastroesophageal reflux disease (GERD), or clinically significant sleep disorder
Various concomitant therapy restrictions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420420

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_534, MK0249-011
Study First Received:	January 9, 2007
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00420420 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
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 September 09, 2009