Alzheimer's Disease, Central Nervous System Diseases, Cognition
Conditions
Keywords
Alzheimer's disease, Central Nervous System diseases, Cognition
Brief summary
This study is being conducted to determine the safety and effect on cognitive function of the investigational medication, EVP-6124, in individuals with mild to moderate probable Alzheimer's disease.
Detailed description
This is a randomized, double-blind, placebo-controlled, parallel, 24-week, Phase 2 safety/efficacy study in which three dose levels of EVP-6124 or placebo will be evaluated. Eligible for enrollment will be patients who meet clinical criteria for mild to moderate probable Alzheimer's disease who are either receiving treatment with AChEI medication at a stable dose or who are not presently taking any AChEI or memantine co-medication. Patients will be randomized to one of the following groups: 0.3 mg, 1 mg or 2 mg or Placebo. Approximately 400 subjects will be randomized to the 4 treatment groups. Study drug will be supplied as capsules and will be orally administered once daily for a total of 24 weeks.
Interventions
DRUGEVP-6124
DRUGPlacebo
Sponsors
INC Research Limited
FORUM Pharmaceuticals Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with Probable Alzheimer's disease * Mini-Mental State Examination (MMSE) score of 14 to 24 inclusive at screening and a CDR-SB score ≥2 at the screening assessment * Modified Hachinski Ischemic Score (mHIS) ≤4 at screening * Female subjects are ≥1 year post-menopausal or are surgically sterile * Caregiver available; if not living in the same household, caregiver sees subject at least four times each week * Subject living at home, senior residential setting, or an institutional setting without the need for continuous nursing care * General health status acceptable for participation in a 24 week clinical trial be administered
Exclusion criteria
General * Participation in another therapeutic clinical trial within 30 days before Baseline * Prior participation in an amyloid vaccination clinical study * Inability to swallow capsules * Likely inability to complete 24 week study * Inability to be ≥75% compliant with single-blind placebo run-in medication * Inability to adequately perform cognitive tests * History of significant cardiovascular disease * Major depression * Psychosis * History of stroke within 18 months of screening * Head trauma * Inability to perform any screening or baseline evaluations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alzheimer's Disease Assessment Scale-Cognitive subscale-13 (ADAS-cog-13) | Day -7, Baseline, 4, 12, 18, 23 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Dementia Rating Scale Sum of Boxes | Day -7, Baseline, 4, 12, 18, 23 Weeks |
| Alzheimer's Disease Cooperative Study-Activities of Daily Living | Baseline, 4, 12, 18, 23 Weeks |
| Neuropsychiatric Inventory | Baseline, 12, 23 Weeks |
| Category Fluency Test | Day -7, Baseline, 4, 12, 18, 23 Weeks |
| Alzheimer's Disease Assessment Scale-Cognitive subscale-11 | 4, 12, 18, 23 Weeks |
| Controlled Oral Word Association Test | Day -7, Baseline, 4, 12, 18, 23 Weeks |
| Mini-Mental State Exam | Day -7, Baseline, 4, 12, 18, 23 Weeks |
Countries
Romania, Russia, Serbia, Ukraine, United States
Outcome results
None listed