Alzheimer's Disease
Conditions
Keywords
donepezil, VI-1121
Brief summary
The purpose of this study is to determine whether VI-1121 is safe, well tolerated, and effective as a daily treatment for Alzheimer's disease that is worsening despite current treatment.
Interventions
DRUGVI-1121
DRUGPlacebo
Sponsors
Medpace, Inc.
VIVUS LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* clinical diagnosis of Alzheimer's disease * CT or MRI within 2 years prior to study * stable dose of current Alzheimer's treatment for at least 3 months
Exclusion criteria
* advanced, severe, progressive or unstable disease * history of cerebrovascular disease or myocardial infarction within 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy variable is the change in Alzheimer's Disease Assessment-Cognitive Subscale (ADAS-Cog) score from baseline to Week 12 of each treatment period. | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy endpoint is the mean change in Mini-Mental State Examination (MMSE) score from baseline to Week 12 of each treatment period. | 12 weeks |
| Percentage of subjects who achieve 3-point improvement in ADAS-Cog score from baseline to Week 12 of each treatment period. | 12 Weeks |
| Change in Clinician's Interview Based Impression of Change Plus Caregiver's Input (CIBIC-plus) score from baseline to Week 12 of each treatment period | 12 Weeks |
| Mean change in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) score from baseline to Weeks 4, 8, and 12 of each treatment period | 4, 8, and 12 Weeks |
Countries
United States
Outcome results
None listed