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

NCT01073228 | Completed Phase 2

• 1 other identifier: EVP-6124-010
• Study Type: interventional
• Target: 409
• Locations: 5 countries
• Sites: 54

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.

Conditions

Alzheimer's Disease; Central Nervous System Diseases; Cognition

Keywords

Alzheimer's disease; Central Nervous System diseases; Cognition

Outcome Measures

Primary Outcomes (1)

• Alzheimer's Disease Assessment Scale-Cognitive subscale-13 (ADAS-cog-13)

  Day -7, Baseline, 4, 12, 18, 23 Weeks

Secondary Outcomes (7)

• 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

Study Arms (4)

EVP-6124 0.3 mg

ACTIVE COMPARATOR

one 0.3 mg capsule every day for 183 days

Drug: EVP-6124

EVP-6124 1 mg

ACTIVE COMPARATOR

one 1 mg capsule every day for 183 days

Drug: EVP-6124

EVP-6124 2 mg

ACTIVE COMPARATOR

one 2 mg capsule every day for 183 days

Drug: EVP-6124

Placebo

PLACEBO COMPARATOR

Placebo every day for 183 days

Drug: Placebo

Interventions

EVP-6124 DRUG

EVP-6124 0.3 mg; EVP-6124 1 mg; EVP-6124 2 mg

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• FORUM Pharmaceuticals Inc: lead
• INC Research Limited: collaborator

Study Sites (54)

HOPE Research Institute

Phoenix, Arizona, 85050, United States

Location

Catalina Research Institute

Chino, California, 91710, United States

Location

ATP Clinical Research

Costa Mesa, California, 92626, United States

Location

University of California, Irvine

Orange, California, 92868, United States

Location

Radiant Research

Santa Rosa, California, 95405, United States

Location

Research Center for Clinical Studies, Inc.

Norwalk, Connecticut, 06851, United States

Location

Chase Medical Research, LLC

Waterbury, Connecticut, 06708, United States

Location

Meridien Research

Brooksville, Florida, 34601, United States

Location

Brain Matters Research

Delray Beach, Florida, 33445, United States

Location

MD Clinical

Hallandale, Florida, 33009, United States

Location

Galiz Research

Miami Springs, Florida, 33166, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

Princeton Medical Institute

Princeton, New Jersey, 08540, United States

Location

Memory Enhancement Center of NJ

Toms River, New Jersey, 08755, United States

Location

Brooklyn Medical Institute

Brooklyn, New York, 11214, United States

Location

Social Psychiatry Research Institute

Brooklyn, New York, 11235, United States

Location

Advanced Bio Behavioral Sciences Inc.

Elmsford, New York, 10523, United States

Location

University of Rochester Medical Center at MCH

Rochester, New York, 14620, United States

Location

Columbus Research and Wellness Institute

Columbus, Ohio, 31909, United States

Location

Summit Research Network

Portland, Oregon, 97210, United States

Location

FutureSearch Trials of Dallas, L.P.

Dallas, Texas, 75231, United States

Location

Grayline Clinical Drug Trials

Wichita Falls, Texas, 76309, United States

Location

The Memory Clinic

Bennington, Vermont, 05201, United States

Location

The Center for Excellence in Aging and Geriatric Health

Williamsburg, Virginia, 23185, United States

Location

Clinical Site 1

Bucharest, Romania

Location

Clinical Site 2

Bucharest, Romania

Location

Clinical Site 3

Bucharest, Romania

Location

Clinical Site 4

Bucharest, Romania

Location

Clinical Site 5

Bucharest, Romania

Location

Unknown Facility

Iași, 700282, Romania

Location

Unknown Facility

Oradea, 410154, Romania

Location

Unknown Facility

Târgu Mureş, Romania

Location

Unknown Facility

Kazan', 420064, Russia

Location

Clinical Site 1

Moscow, 115552, Russia

Location

Clinical Site 2

Moscow, Russia

Location

Clinical Site 1

Saint Petersburg, 190005, Russia

Location

Clinical Site 2

Saint Petersburg, 190103, Russia

Location

Clinical Site 3

Saint Petersburg, 194175, Russia

Location

Clinical Site 4

Saint Petersburg, Russia

Location

Unknown Facility

Saratov, 410060, Russia

Location

Unknown Facility

Voronezh, 394052, Russia

Location

Unknown Facility

Yekaterinburg, Russia

Location

Clinical site 1

Belgrade, 11000, Serbia

Location

Clinical Site 2

Belgrade, 11000, Serbia

Location

Unknown Facility

Kragujevac, 34000, Serbia

Location

Unknown Facility

Niš, 18000, Serbia

Location

Unknown Facility

Dnipro, 490005, Ukraine

Location

Unknown Facility

Donets'k, 83037, Ukraine

Location

(1)

Kyiv, 04080, Ukraine

Location

(2)

Kyiv, 04080, Ukraine

Location

Unknown Facility

Odesa, 65006, Ukraine

Location

Unknown Facility

Simferopol, 95006, Ukraine

Location

Unknown Facility

Vinnytsia, 21005, Ukraine

Location

MeSH Terms

Conditions

Alzheimer Disease; Central Nervous System Diseases

Interventions

7-chloro-N-quinuclidin-3-yl-benzo(b)thiophene-2-carboxamide

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2010
• First Posted: February 23, 2010
• Study Start: April 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: February 1, 2012
• Last Updated: April 25, 2014

Record last verified: 2013-02

Locations

UA (7); SE (4); US (25); RO (8); RU (10)