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Completed

NCT Number: NCT00420420

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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK0249

Drug

MK0249 two (2) 2.5 mg capsules quaque die (qd) for 28 day treatment period.

Comparator: Placebo (Unspecified)

Drug

MK0249 two (2) 2.5 mg Pbo capsules qd for a 28 day treatment period

Primary outcomes

  1. Week 4 Change From Baseline in Computerized Neuropsychological Test Battery (CNTB): Short CNTB Summary Score.

    Time frame: Baseline and Week 4

    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.

  2. 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

    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 outcomes

  1. Week 4 Change From Baseline in Cognition Summary Score (CSS)

    Time frame: Baseline and Week 4

    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 outcomes

  1. Baseline: Short CNTB Summary Score.

    Time frame: Baseline

    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.

  2. Baseline: ADAS-Cog Total Score

    Time frame: Baseline

    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.

  3. Baseline: Cognition Summary Score (CSS)

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 11, 2007
Registry last updated
Feb 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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