MK0249 for the Symptomatic Treatment of Alzheimer's Disease (MK0249-011)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00420420
First received: January 9, 2007
Last updated: April 29, 2014
Last verified: April 2014
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Week 4 Change From Baseline in Computerized Neuropsychological Test Battery (CNTB): Short CNTB Summary Score. [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    The CNTB was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the short CNTB summary score. The short CNTB summary score was scored as the mean score across 5 modules: Word List Learning-Selective Reminding, Word List Learning-Delayed Recall, Simple Reaction Time, Choice Reaction Time, and Visual Memory subtests. The short CNTB summary score ranges from 0 to 100, with higher scores (and positive changes from baseline) indicating better performance.

  • Week 4 Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog): ADAS-Cog Total Score [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    The ADAS-Cog, scored as the total score of 11 tasks including mazes was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the ADAS-Cog total score. The ADAS-Cog total score ranges from 0 to 70, with higher total scores indicating more impairment. Lower scores (and negative changes from Baseline) indicate better performance.


Secondary Outcome Measures:
  • Week 4 Change From Baseline in Cognition Summary Score (CSS) [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    The CSS was used to evaluate cognitive function as measured by the mean change from Baseline to Week 4 in the CSS total score. The CSS was derived from the correct sequence percentage from the Route Test and 6 of the CNTB scores (the CSS was scored as the mean of the 7 scores). CSS scores can range from 0 to 100, higher scores (and positive changes from baseline) indicate better performance.


Other Outcome Measures:
  • Baseline: Short CNTB Summary Score. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The CNTB was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the short CNTB summary score. The short CNTB summary score was scored as the mean score across 5 modules: Word List Learning-Selective Reminding, Word List Learning-Delayed Recall, Simple Reaction Time, Choice Reaction Time, and Visual Memory subtests. The short CNTB summary score ranges from 0 to 100, with higher scores (and positive changes from baseline) indicating better performance.

  • Baseline: ADAS-Cog Total Score [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The ADAS-Cog, scored as the total score of 11 tasks including mazes was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the ADAS-Cog total score. The ADAS-Cog total score ranges from 0 to 70, with higher total scores indicating more impairment. Lower scores (and negative changes from Baseline) indicate better performance.

  • Baseline: Cognition Summary Score (CSS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The CSS was used to evaluate cognitive function as measured by the mean change from Baseline to Week 4 in the CSS total score. The CSS was derived from the correct sequence percentage from the Route Test and 6 of the CNTB scores (the CSS was scored as the mean of the 7 scores). CSS scores can range from 0 to 100, higher scores (and positive changes from baseline) indicate better performance.


Enrollment: 144
Study Start Date: November 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK0249 Drug: MK0249
MK0249 two (2) 2.5 mg capsules quaque die (qd) for 28 day treatment period.
Placebo Comparator: placebo Drug: Comparator: Placebo (unspecified)
MK0249 two (2) 2.5 mg Pbo capsules 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 Mini Mental State Examination (MMSE) between 18 and 26, inclusive, Modified Hachinski Ischemic Scale (MHIS) score =/<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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00420420     History of Changes
Other Study ID Numbers: 0249-011, 2006_534
Study First Received: January 9, 2007
Results First Received: October 25, 2010
Last Updated: April 29, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 20, 2014