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

Information source: FORUM Pharmaceuticals Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alzheimer's Disease; Central Nervous System Diseases; Cognition

Intervention: EVP-6124 (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: FORUM Pharmaceuticals Inc

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.

Clinical Details

Official title: A Randomized, Double-blind, Placebo-Controlled, Parallel, 24-Week, Phase 2 Study of Three Different Doses of an Alpha-7 Nicotinic Acetylcholine Receptor Agonist (EVP-6124) or Placebo in Subjects With Mild to Moderate Probable Alzheimer's Disease

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Alzheimer's Disease Assessment Scale-Cognitive subscale-13 (ADAS-cog-13)

Secondary outcome:

Alzheimer's Disease Assessment Scale-Cognitive subscale-11

Controlled Oral Word Association Test

Category Fluency Test

Clinical Dementia Rating Scale Sum of Boxes

Alzheimer's Disease Cooperative Study-Activities of Daily Living

Neuropsychiatric Inventory

Mini-Mental State Exam

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.

Eligibility

Minimum age: 50 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

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

Additional Information

Starting date: April 2010
Last updated: March 28, 2014

Page last updated: August 23, 2015

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