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

Age-Related Memory Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00109564
• Other study ID #: TC-1734-112-CRD-004
• Status: Completed
• Phase: Phase 2
• First received: April 28, 2005
• Last updated: July 17, 2008
• Start date: January 2005
• Est. completion date: October 2005

Study information

• Verified date: July 2008
• Source: Targacept Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: October 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Memory Disorders
• Memory Disorders

Intervention

Drug:
• ispronicline (nicotinic acetylcholine receptor agonist)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Targacept Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.

External Links

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