Phase 1
N=106
A Study to Test the Performance of the CogState Computerized Neuropsychological Battery in Patients With Alzheimer's Disease (0000-086)(COMPLETED)
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00777608 ↗Enrolled (actual)
106
Serious AEs
2.8%
Results posted
Feb 2011
Primary outcome: Primary: Change in Mean Computer-based Cognitive Assessment (CogState) Composite Score at Week 4 — -0.10; -0.07 Score on a scale — p=0.231
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Comparator: Placebo 5mg (run in) (Drug); Donepezil 5 - 10 mg (Drug); Comparator: Placebo 5-10 mg (Drug); Donepezil 10 mg (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Computer-based Cognitive Assessment (CogState) Composite Score at Week 4 |
-0.10; -0.07 | 0.231 |
| SECONDARY Evaluate the Efficacy of Donepezil by Determining the Change in Mean CogState Composite Score at Week 2, Week 8 and Week 12 |
-0.2; -0.006; -0.1; -0.02; -0.2; -0.09 | 0.041 sig |
| SECONDARY Evaluate the Efficacy of Donepezil by Determining the Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score at Week 4, Week 8 and Week 12 |
0.2; -0.3; 0.07; -0.7; -1.4; -1.0 | 0.324 |
Summary
This study will evaluate the performance of the CogState computerized neuropsychological battery, Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) and Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) in participants with mild-to-moderate Alzheimer's disease (AD).
Eligibility Criteria
Inclusion Criteria
- Participant is ambulatory, male or female and 55 years of age or older
- Participant has reliable informant/caregiver who can communicate effectively with the study site and personnel
Exclusion Criteria
- Participant has a history within the last 6 months or current evidence of a psychotic disorder or an active major depressive disorder or participant has any history of schizophrenia
- Participant has a history of multiple and/or serious allergies to drugs or food or a history of an allergic reaction to more than 3 drug classes
Data sourced from ClinicalTrials.gov (NCT00777608). 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.