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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: MK0249
* Drug: Comparator: Placebo (unspecified)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MK0249<br> | Drug: MK0249<br>* MK0249 two (2) 2.5 mg capsules quaque die (qd) for 28 day treatment period.<br>|
| Placebo Comparator: placebo<br> | Drug: Comparator: Placebo (unspecified)<br>* MK0249 two (2) 2.5 mg Pbo capsules qd for a 28 day treatment period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Week 4 Change From Baseline in Computerized Neuropsychological Test Battery (CNTB): Short CNTB Summary Score. | 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 and Week 4 | 
| Week 4 Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog): ADAS-Cog Total Score | 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 and Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Week 4 Change From Baseline in Cognition Summary Score (CSS) | 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. | Baseline and Week 4 |