Status:
COMPLETED
Study of LX6171 in Elderly Volunteers With Age Associated Memory Impairment
Lead Sponsor:
Lexicon Pharmaceuticals
Conditions:
Age-Related Memory Disorders
Eligibility:
All Genders
60-80 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to determine the safety, tolerability, and effectiveness of 2 dose levels of LX6171 given over 28 days in patients with Age Associated Memory Impairment (AAMI).
Eligibility Criteria
Inclusion
- Males and females aged 60-80 years old.
- Complaints of memory loss in everyday life
- Non-smokers or very light smokers (no more than 10 cigarettes/day)
- Negative urine screen for drugs of abuse
- Ability to provide written informed consent
Exclusion
- History or evidence of any disease, disorder or injury that could cause cognitive deterioration.
- Need for medications other than hormone replacement therapy, daily vitamins, or over-the-counter pain killers
- Clinically significant abnormality on electrocardiogram
- History of alcoholism or drug dependence
- Use of dietary supplements containing Huperzine A, gingko biloba, phosphatidylserine, or Docosahexaenoic acid (DHA)
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00691808
Start Date
February 1 2008
Last Update
March 3 2010
Active Locations (2)
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1
Kendle Netherlands
Utrecht, Netherlands, 3584
2
Pharmaceutical Research Associates Group BV
Zuidlaren, Netherlands, 9470