NCT01073228

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 409 (actual)
• Sponsor: FORUM Pharmaceuticals Inc · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	EVP-6124
DRUG	Placebo

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-11-01
• Completion: 2012-02-01
• First posted: 2010-02-23
• Last updated: 2014-04-25

Locations

54 sites across 5 countries: United States, Romania, Russia, Serbia, Ukraine