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

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Targacept Inc.
• Treatments: Acetylcholine; Nicotinic Agonists

Criteria

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.