A Safety and Efficacy Study of Ispronicline (TC-1734-112) in Subjects With Age Associated Memory Impairment (AAMI)
- Conditions
- Age-Related Memory Disorders
- Registration Number
- NCT00109564
- Lead Sponsor
- Targacept Inc.
- 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 (AAMI). AAMI is characterized as cognitive impairment including memory loss and poor concentration associated with aging.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 174
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To assess safety and tolerability of ispronicline vs. placebo in generally healthy elderly subjects with subjective and objective memory impairment meeting the generally accepted criteria for AAMI. To assess effect, on cognition, of ispronicline vs. placebo in generally healthy elderly subjects with subjective and objective memory impairment meeting the generally accepted criteria for AAMI.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Pivotal Research Center
🇺🇸Peoria, Arizona, United States
Meridien Research
🇺🇸Tampa, Florida, United States
Hartford Research
🇺🇸Florence, Kentucky, United States
Neuropsychiatric Research Center of SW Florida
🇺🇸Fort Meyers, Florida, United States
Northlake Medical Research Center
🇺🇸Decatur, Georgia, United States
Berman Center
🇺🇸Minneapolis, Minnesota, United States
Kulynych Research Center
🇺🇸Greensboro, North Carolina, United States
Radiant Research Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Radiant Research
🇺🇸Salt Lake City, Utah, United States