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

This study has been completed.
Information provided by:
Targacept Inc. Identifier:
First received: April 28, 2005
Last updated: July 17, 2008
Last verified: July 2008
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.

Condition Intervention Phase
Age-Related Memory Disorders
Drug: ispronicline (nicotinic acetylcholine receptor agonist)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Safety and Efficacy Study of TC-1734-112 in Subjects With Age Associated Memory Impairment (AAMI)

Resource links provided by NLM:

Further study details as provided by Targacept Inc.:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 174
Study Start Date: January 2005
Estimated Study Completion Date: October 2005

Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00109564

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Pivotal Research Center
Mesa, Arizona, United States, 85210
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Peoria, Arizona, United States, 85381
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Denver, Colorado, United States, 80212
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Neuropsychiatric Research Center of SW Florida
Fort Meyers, Florida, United States, 33912
Meridien Research
St. Petersberg, Florida, United States, 33709
Meridien Research
Tampa, Florida, United States, 33609
United States, Georgia
Northlake Medical Research Center
Decatur, Georgia, United States, 30033
United States, Kentucky
Hartford Research
Florence, Kentucky, United States, 41042
United States, Minnesota
Berman Center
Minneapolis, Minnesota, United States, 55404
United States, Missouri
Radiant Research
St. Louis, Missouri, United States, 63141
United States, North Carolina
Kulynych Research Center
Greensboro, North Carolina, United States, 27408
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
Radiant Research Philadelphia
Philadelphia, Pennsylvania, United States, 19115
United States, Texas
Radiant Research
San Antonio, Texas, United States, 78229
United States, Utah
Radiant Research
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Targacept Inc.
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00109564     History of Changes
Other Study ID Numbers: TC-1734-112-CRD-004
Study First Received: April 28, 2005
Last Updated: July 17, 2008

Keywords provided by Targacept Inc.:
Memory Impairment
Decline in Cognitive Function
Age Associated Memory Impairment

Additional relevant MeSH terms:
Memory Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasodilator Agents processed this record on April 26, 2017