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

NCT ID: NCT00109564

Last Updated: 2008-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Age-Related Memory Disorders

Keywords

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AAMI Memory Impairment Decline in Cognitive Function Age Associated Memory Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ispronicline (nicotinic acetylcholine receptor agonist)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Targacept Inc.

INDUSTRY

Sponsor Role lead

Locations

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Pivotal Research Center

Mesa, Arizona, United States

Site Status

Pivotal Research Center

Peoria, Arizona, United States

Site Status

Radiant Research

Denver, Colorado, United States

Site Status

Neuropsychiatric Research Center of SW Florida

Fort Meyers, Florida, United States

Site Status

Meridien Research

Saint Petersberg, Florida, United States

Site Status

Meridien Research

Tampa, Florida, United States

Site Status

Northlake Medical Research Center

Decatur, Georgia, United States

Site Status

Hartford Research

Florence, Kentucky, United States

Site Status

Berman Center

Minneapolis, Minnesota, United States

Site Status

Radiant Research

St Louis, Missouri, United States

Site Status

Kulynych Research Center

Greensboro, North Carolina, United States

Site Status

Wake Forest University

Winston-Salem, North Carolina, United States

Site Status

Radiant Research Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Radiant Research

San Antonio, Texas, United States

Site Status

Radiant Research

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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Dunbar GC, Kuchibhatla RV, Lee G; TC-1734 (AZD3480) AAMI Clinical Study Group (USA). A randomized double-blind study comparing 25 and 50 mg TC-1734 (AZD3480) with placebo, in older subjects with age-associated memory impairment. J Psychopharmacol. 2011 Aug;25(8):1020-9. doi: 10.1177/0269881110367727. Epub 2010 Jun 11.

Reference Type DERIVED
PMID: 20542923 (View on PubMed)

Other Identifiers

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TC-1734-112-CRD-004

Identifier Type: -

Identifier Source: org_study_id