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

Completed · Phase 1 · Has a placebo group

Conditions studied: Alzheimer's Disease, Central Nervous System Diseases

In brief

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.

Key facts

Study ID

NCT00766363

Run by

FORUM Pharmaceuticals Inc

People needed

49

Starts

2008-10-01

Expected to finish

2009-03-01

Last updated by the study team

2012-04-20

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Pacific Research Network, Inc. — San Diego, California, United States
• MD Clinical — Hallandale, Florida, United States
• Comprehensive Clinical Research — Berlin, New Jersey, United States
• Global Medical Institutes, LLC — Princeton, New Jersey, United States

Full record on ClinicalTrials.gov

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