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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01073228
• Other study ID #: EVP-6124-010
• Status: Completed
• Phase: Phase 2
• First received: February 19, 2010
• Last updated: March 28, 2014
• Start date: April 2010
• Est. completion date: February 2012

Study information

• Verified date: February 2013
• Source: FORUM Pharmaceuticals Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 409
• Est. completion date: February 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Central Nervous System Diseases
• Cognition
• Nervous System Diseases

Intervention

Drug:
• EVP-6124

• Placebo

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
FORUM Pharmaceuticals Inc	INC Research Limited

Countries where clinical trial is conducted

United States,  Romania,  Russian Federation,  Serbia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alzheimer's Disease Assessment Scale-Cognitive subscale-13 (ADAS-cog-13)		Day -7, Baseline, 4, 12, 18, 23 Weeks
Secondary	Alzheimer's Disease Assessment Scale-Cognitive subscale-11		4, 12, 18, 23 Weeks
Secondary	Controlled Oral Word Association Test		Day -7, Baseline, 4, 12, 18, 23 Weeks
Secondary	Category Fluency Test		Day -7, Baseline, 4, 12, 18, 23 Weeks
Secondary	Clinical Dementia Rating Scale Sum of Boxes		Day -7, Baseline, 4, 12, 18, 23 Weeks
Secondary	Alzheimer's Disease Cooperative Study-Activities of Daily Living		Baseline, 4, 12, 18, 23 Weeks
Secondary	Neuropsychiatric Inventory		Baseline, 12, 23 Weeks
Secondary	Mini-Mental State Exam		Day -7, Baseline, 4, 12, 18, 23 Weeks