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

Information source: Targacept Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Age-Related Memory Disorders

Intervention: ispronicline (nicotinic acetylcholine receptor agonist) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Targacept Inc.

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.

Clinical Details

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

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

Primary outcome:

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.

Eligibility

Minimum age: 50 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Locations and Contacts

Pivotal Research Center, Mesa, Arizona 85210, United States

Pivotal Research Center, Peoria, Arizona 85381, United States

Radiant Research, Denver, Colorado 80212, United States

Neuropsychiatric Research Center of SW Florida, Fort Meyers, Florida 33912, United States

Meridien Research, St. Petersberg, Florida 33709, United States

Meridien Research, Tampa, Florida 33609, United States

Northlake Medical Research Center, Decatur, Georgia 30033, United States

Hartford Research, Florence, Kentucky 41042, United States

Berman Center, Minneapolis, Minnesota 55404, United States

Radiant Research, St. Louis, Missouri 63141, United States

Kulynych Research Center, Greensboro, North Carolina 27408, United States

Wake Forest University, Winston-Salem, North Carolina 27157, United States

Radiant Research Philadelphia, Philadelphia, Pennsylvania 19115, United States

Radiant Research, San Antonio, Texas 78229, United States

Radiant Research, Salt Lake City, Utah 84107, United States

Additional Information

Starting date: January 2005
Last updated: July 17, 2008

Page last updated: August 23, 2015

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