Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Alzheimer's Disease

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is being conducted to determine the safety, tolerability, and pharmacokinetics (PK) of three different doses of an investigational medication, EVP-6124, in individuals with mild to moderate Alzheimer's disease who are also taking an Alzheimer's medication (AChEI [acetylcholinesterase inhibitor]: either donepezil or rivastigmine). In addition, PK of AChEI medications will be assessed. Cognitive function will be evaluated on an exploratory basis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FORUM Pharmaceuticals Inc
• Collaborators: INC Research; Syneos Health
• Treatments: Donepezil; Nicotinic Agonists; Rivastigmine

Criteria

Inclusion Criteria:

• male and post-menopausal or surgically sterile female pts

• 50-90 yrs old, who meet clinical criteria for probable Alzheimer's disease (Mini-Mental State Examination of 18-26; Hachinski Ischemic Score ≤4)

• must be taking donepezil or rivastigmine for at least 3 mos.

Exclusion Criteria:

• Unstable medical condition that is clinically significant in the judgment of the investigator; major organ system dysfunction

• Untreated hypothyroidism

• Insufficiently controlled diabetes mellitus

• Diagnosis of major depression requiring antidepressant medications within the last 5 years

• Stroke within 6 months before screening, or concomitant with onset of dementia

• Certain concomitant medications