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

Phase 2

Completed

Conditions: Alzheimer's Disease
Central Nervous System Diseases
Cognition

Interventions: Drug: EVP-6124
Drug: Placebo

Registration Number: NCT01073228

Lead Sponsor: FORUM Pharmaceuticals Inc

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 409

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EVP-6124 2 mg	EVP-6124	one 2 mg capsule every day for 183 days
EVP-6124 1 mg	EVP-6124	one 1 mg capsule every day for 183 days
EVP-6124 0.3 mg	EVP-6124	one 0.3 mg capsule every day for 183 days
Placebo	Placebo	Placebo every day for 183 days

Primary Outcome Measures

Name	Time	Method
Alzheimer's Disease Assessment Scale-Cognitive subscale-13 (ADAS-cog-13)	Day -7, Baseline, 4, 12, 18, 23 Weeks

Secondary Outcome Measures

Name	Time	Method
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
Category Fluency Test	Day -7, Baseline, 4, 12, 18, 23 Weeks
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
Mini-Mental State Exam	Day -7, Baseline, 4, 12, 18, 23 Weeks

Trial Locations

Locations (33): University of California, Irvine
🇺🇸
Orange, California, United States
Clinical Site 2
🇷🇸
Belgrade, Serbia
Renstar Medical Research
🇺🇸
Ocala, Florida, United States
Compass Research, LLC
🇺🇸
Orlando, Florida, United States
Columbus Research and Wellness Institute
🇺🇸
Columbus, Ohio, United States
Catalina Research Institute
🇺🇸
Chino, California, United States
MD Clinical
🇺🇸
Hallandale Beach, Florida, United States
Clinical Site 5
🇷🇴
Bucharest, Romania
Clinical Site 3
🇷🇺
St Petersburg, Russian Federation
Galiz Research
🇺🇸
Miami Springs, Florida, United States
(1)
🇺🇦
Kyiv, Ukraine
Clinical Site 1
🇷🇺
St. Petersburg, Russian Federation
FutureSearch Trials of Dallas, L.P.
🇺🇸
Dallas, Texas, United States
Clinical site 1
🇷🇸
Belgrade, Serbia
(2)
🇺🇦
Kyiv, Ukraine
The Memory Clinic
🇺🇸
Bennington, Vermont, United States
The Center for Excellence in Aging and Geriatric Health
🇺🇸
Williamsburg, Virginia, United States
Brooklyn Medical Institute
🇺🇸
Brooklyn, New York, United States
Social Psychiatry Research Institute
🇺🇸
Brooklyn, New York, United States
University of Rochester Medical Center at MCH
🇺🇸
Rochester, New York, United States
ATP Clinical Research
🇺🇸
Costa Mesa, California, United States
HOPE Research Institute
🇺🇸
Phoenix, Arizona, United States
Brain Matters Research
🇺🇸
Delray Beach, Florida, United States
Meridien Research
🇺🇸
Brooksville, Florida, United States
Advanced Bio Behavioral Sciences Inc.
🇺🇸
Elmsford, New York, United States
Grayline Clinical Drug Trials
🇺🇸
Wichita Falls, Texas, United States
Clinical Site 4
🇷🇺
St Petersburg, Russian Federation
Research Center for Clinical Studies, Inc.
🇺🇸
Norwalk, Connecticut, United States
Chase Medical Research, LLC
🇺🇸
Waterbury, Connecticut, United States
Princeton Medical Institute
🇺🇸
Princeton, New Jersey, United States
Memory Enhancement Center of NJ
🇺🇸
Toms River, New Jersey, United States
Summit Research Network
🇺🇸
Portland, Oregon, United States
Radiant Research
🇺🇸
Santa Rosa, California, United States