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.
Minimum age: 50 Years.
Maximum age: 85 Years.
Gender(s): Both.
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
Clinical Site 1, Bucharest, Romania
Clinical Site 2, Bucharest, Romania
Clinical Site 3, Bucharest, Romania
Clinical Site 4, Bucharest, Romania
Clinical Site 5, Bucharest, Romania
Iasi 700282, Romania
Oradea 410154, Romania
Tirgu Mures, Romania
Kazan 420064, Russian Federation
Clinical Site 1, Moscow 115552, Russian Federation
Clinical Site 2, Moscow, Russian Federation
Saratov 410060, Russian Federation
Clinical Site 3, St Petersburg 194175, Russian Federation
Clinical Site 4, St Petersburg, Russian Federation
Clinical Site 1, St. Petersburg 190005, Russian Federation
Clinical Site 2, St. Petersburg 190103, Russian Federation
Voronezh 394052, Russian Federation
Yekaterinburg, Russian Federation
Clinical site 1, Belgrade 11000, Serbia
Clinical Site 2, Belgrade 11000, Serbia
Kragujevac 34000, Serbia
Nis 18000, Serbia
Dnipropetrovs'k 490005, Ukraine
Donets'k 83037, Ukraine
(1), Kyiv 04080, Ukraine
(2), Kyiv 04080, Ukraine
Odesa 65006, Ukraine
Simferopol 95006, Ukraine
Vinnytsya 21005, Ukraine
HOPE Research Institute, Phoenix, Arizona 85050, United States
Catalina Research Institute, Chino, California 91710, United States
ATP Clinical Research, Costa Mesa, California 92626, United States
University of California, Irvine, Orange, California 92868, United States
Radiant Research, Santa Rosa, California 95405, United States
Research Center for Clinical Studies, Inc., Norwalk, Connecticut 06851, United States
Chase Medical Research, LLC, Waterbury, Connecticut 06708, United States
Meridien Research, Brooksville, Florida 34601, United States
Brain Matters Research, Delray Beach, Florida 33445, United States
MD Clinical, Hallandale Beach, Florida 33009, United States
Galiz Research, Miami Springs, Florida 33166, United States
Renstar Medical Research, Ocala, Florida 34471, United States
Compass Research, LLC, Orlando, Florida 32806, United States
Princeton Medical Institute, Princeton, New Jersey 08540, United States
Memory Enhancement Center of NJ, Toms River, New Jersey 08755, United States
Brooklyn Medical Institute, Brooklyn, New York 11214, United States
Social Psychiatry Research Institute, Brooklyn, New York 11235, United States
Advanced Bio Behavioral Sciences Inc., Elmsford, New York 10523, United States
University of Rochester Medical Center at MCH, Rochester, New York 14620, United States
Columbus Research and Wellness Institute, Columbus, Ohio 31909, United States
Summit Research Network, Portland, Oregon 97210, United States
FutureSearch Trials of Dallas, L.P., Dallas, Texas 75231, United States
Grayline Clinical Drug Trials, Wichita Falls, Texas 76309, United States
The Memory Clinic, Bennington, Vermont 05201, United States
The Center for Excellence in Aging and Geriatric Health, Williamsburg, Virginia 23185, United States