CompletedNCT00109564Updated Jul 18, 2008

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

A Phase 2 interventional study of ispronicline (nicotinic acetylcholine receptor agonist) in Age-Related Memory Disorders, sponsored by Targacept Inc.. Completed at 15 sites in United States. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-07-18.

Sponsored by Targacept Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 174
Allocation: Randomized
Ages: 50 Years to 80 Years
Sex: All

Study 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.

Conditions studied

Age-Related Memory Disorders

Browse trials for

Memory Disorders 260

Keywords

AAMI
Memory Impairment
Decline in Cognitive Function
Age Associated Memory Impairment

In context

Memory Disorders

260 studies on the registry are indexed under Memory Disorders; 60 are open to participants now.

This study's enrollment of 174 is above the median of 73 across 207 interventional studies indexed under Memory Disorders.

Browse Memory Disorders studies →

Lead sponsor

Targacept Inc. is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 50 Years to 80 Years
Sexes eligible: 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

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

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double
Enrollment: 174 participants

Interventions

Drugispronicline (nicotinic acetylcholine receptor agonist)

What researchers measure

Primary outcomes

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.

Study locations

15 sites

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

References and documents

Publications

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. PubMed 20542923 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 18, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00109564
Lead sponsor: Targacept Inc.
First posted: Apr 29, 2005
Start date: Jan 2005
Completion: Oct 2005
Last update: Jul 18, 2008

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.

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