A Safety and Efficacy Study of Ispronicline (TC-1734-112) in Subjects With Age Associated Memory Impairment (AAMI)

Completed · Phase 2

Conditions studied: Age-Related Memory Disorders

In brief

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.

Key facts

Study ID

NCT00109564

Run by

Targacept Inc.

People needed

174

Starts

2005-01-01

Expected to finish

2005-10-01

Last updated by the study team

2008-07-18

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pivotal Research Center — Mesa, Arizona, United States
• Pivotal Research Center — Peoria, Arizona, United States
• Radiant Research — Denver, Colorado, United States
• Neuropsychiatric Research Center of SW Florida — Fort Meyers, Florida, United States
• Meridien Research — Saint Petersberg, Florida, United States
• Meridien Research — Tampa, Florida, United States
• Northlake Medical Research Center — Decatur, Georgia, United States
• Hartford Research — Florence, Kentucky, United States
• Berman Center — Minneapolis, Minnesota, United States
• Radiant Research — St Louis, Missouri, United States
• Kulynych Research Center — Greensboro, North Carolina, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• Radiant Research Philadelphia — Philadelphia, Pennsylvania, United States
• Radiant Research — San Antonio, Texas, United States
• Radiant Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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