Safety and Cognitive Function Study of EVP-6124 in Patients With Mild to Moderate Alzheimer's Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease, Central Nervous System Diseases, Cognition

In brief

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.

Key facts

Study ID

NCT01073228

Run by

FORUM Pharmaceuticals Inc

People needed

409

Starts

2010-04-01

Expected to finish

2012-02-01

Last updated by the study team

2014-04-25

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Catalina Research Institute — Chino, California, United States
• ATP Clinical Research — Costa Mesa, California, United States
• University of California, Irvine — Orange, California, United States
• Radiant Research — Santa Rosa, California, United States
• Research Center for Clinical Studies, Inc. — Norwalk, Connecticut, United States
• Chase Medical Research, LLC — Waterbury, Connecticut, United States
• Meridien Research — Brooksville, Florida, United States
• Brain Matters Research — Delray Beach, Florida, United States
• MD Clinical — Hallandale, Florida, United States
• Galiz Research — Miami Springs, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Compass Research, LLC — Orlando, Florida, United States
• Princeton Medical Institute — Princeton, New Jersey, United States
• Memory Enhancement Center of NJ — Toms River, New Jersey, United States
• Brooklyn Medical Institute — Brooklyn, New York, United States
• Social Psychiatry Research Institute — Brooklyn, New York, United States
• Advanced Bio Behavioral Sciences Inc. — Elmsford, New York, United States
• University of Rochester Medical Center at MCH — Rochester, New York, United States
• Columbus Research and Wellness Institute — Columbus, Ohio, United States
• Summit Research Network — Portland, Oregon, United States
• FutureSearch Trials of Dallas, L.P. — Dallas, Texas, United States
• Grayline Clinical Drug Trials — Wichita Falls, Texas, United States
• The Memory Clinic — Bennington, Vermont, United States
• The Center for Excellence in Aging and Geriatric Health — Williamsburg, Virginia, United States
• HOPE Research Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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