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Completed

NCT Number: NCT00109564

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

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.

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Key information

Conditions

Age-related Memory Disorders Memory Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pivotal Research Center, Mesa, Arizona, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ispronicline (nicotinic acetylcholine receptor agonist)

Drug

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Targacept Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2005
First posted
Apr 29, 2005
Registry last updated
Jul 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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