Status:
COMPLETED
Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Alzheimer's Disease
Lead Sponsor:
FORUM Pharmaceuticals Inc
Collaborating Sponsors:
Syneos Health
Conditions:
Alzheimer's Disease
Central Nervous System Diseases
Eligibility:
All Genders
50-90 years
Phase:
PHASE1
Brief 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...
Detailed Description
This is a randomized, double-blind, placebo-controlled, Phase 1b safety study of three dose levels of EVP-6124 in subjects with mild or moderate Alzheimer's disease and who are taking an AChEI medicat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00766363
Start Date
October 1 2008
End Date
March 1 2009
Last Update
April 20 2012
Active Locations (4)
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1
Pacific Research Network, Inc.
San Diego, California, United States, 92103
2
MD Clinical
Hallandale, Florida, United States, 33009
3
Comprehensive Clinical Research
Berlin, New Jersey, United States, 08009
4
Global Medical Institutes, LLC
Princeton, New Jersey, United States, 08540