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

July 17, 2008 updated by: Targacept Inc.

A Safety and Efficacy Study of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

174

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Targacept Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Study Completion

October 1, 2005

Study Registration Dates

First Submitted

April 28, 2005

First Submitted That Met QC Criteria

April 28, 2005

First Posted (Estimate)

April 29, 2005

Study Record Updates

Last Update Posted (Estimate)

July 18, 2008

Last Update Submitted That Met QC Criteria

July 17, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TC-1734-112-CRD-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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