Status:
COMPLETED
A Safety and Efficacy Study of Ispronicline (TC-1734-112) in Subjects With Age Associated Memory Impairment (AAMI)
Lead Sponsor:
Targacept Inc.
Conditions:
Age-Related Memory Disorders
Eligibility:
All Genders
50-80 years
Phase:
PHASE2
Brief Summary
The purpose of this Phase II study is to evaluate the efficacy and safety of ispronicline (TC-1734-112) compared to placebo (inactive substance pill) in patients with age associated memory impairment ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Male or female subjects aged 50-80 years.
- Lives with a significant other.
- Has subjective memory complaints. Verbal verification of this subjective memory complaint will be obtained from the significant other.
- Has no severe, uncontrolled medical condition.
- If receiving treatment for a medical condition, that treatment has been stable for at least 2 months before entering the trial and to remain stable throughout the trial.
- Exclusion Criteria
- Aged less than 50 years or greater than 80 years.
- Lives alone.
- Has any medical condition not adequately controlled, or likely to interfere with performance of the study procedures.
- Medication for a medical condition has been changed in the last 2 months or during the trial.
- Administration of acetylcholinesterase inhibitors and gingko biloba within 2 months prior to entering the study.
- Has evidence of depression or anxiety
- Meets DSM-IV criteria for Alzheimer's or vascular dementia.
- Has participated in an investigational drug trial in the previous 30 days.
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT00109564
Start Date
January 1 2005
End Date
October 1 2005
Last Update
July 18 2008
Active Locations (15)
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1
Pivotal Research Center
Mesa, Arizona, United States, 85210
2
Pivotal Research Center
Peoria, Arizona, United States, 85381
3
Radiant Research
Denver, Colorado, United States, 80212
4
Neuropsychiatric Research Center of SW Florida
Fort Meyers, Florida, United States, 33912