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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FORUM Pharmaceuticals Inc
• Collaborator: INC Research Limited
• Treatments: Nicotinic Agonists

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