Phase 2
Completed N=144
MK0249 for the Symptomatic Treatment of Alzheimer's Disease (MK0249-011)
Source: ClinicalTrials.gov NCT00420420 ↗Enrolled (actual)
144
Serious AEs
2.8%
Results posted
Nov 2010
Primary outcomePrimary: Week 4 Change From Baseline in Computerized Neuropsychological Test Battery (CNTB): Short CNTB Summary Score. — 0.13; -0.76 units on a scale — p=0.283
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Week 4 Change From Baseline in Computerized Neuropsychological Test Battery (CNTB): Short CNTB Summary Score. |
0.13; -0.76 | 0.283 |
| PRIMARY Week 4 Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog): ADAS-Cog Total Score |
-1.42; -1.17 | 0.716 |
| SECONDARY Week 4 Change From Baseline in Cognition Summary Score (CSS) |
1.19; -0.19 | 0.180 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00420420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.