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

Purpose

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.

Condition	Intervention	Phase
Age-Related Memory Disorders	Drug: ispronicline (nicotinic acetylcholine receptor agonist)	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Safety and Efficacy Study of TC-1734-112 in Subjects With Age Associated Memory Impairment (AAMI)

Resource links provided by NLM:

MedlinePlus related topics: Memory

Drug Information available for: Acetylcholine chloride

U.S. FDA Resources

Further study details as provided by Targacept Inc.:

Primary Outcome Measures:

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.


Estimated Enrollment:	174
Study Start Date:	January 2005
Estimated Study Completion Date:	October 2005

Eligibility


Ages Eligible for Study:	50 Years to 80 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00109564

Locations


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

Sponsors and Collaborators

Targacept Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


ClinicalTrials.gov Identifier:	NCT00109564 History of Changes
Other Study ID Numbers:	TC-1734-112-CRD-004
Study First Received:	April 28, 2005
Last Updated:	July 17, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Targacept Inc.:


AAMI Memory Impairment Decline in Cognitive Function Age Associated Memory Impairment

Additional relevant MeSH terms:


Memory Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Acetylcholine Nicotinic Agonists	Vasodilator Agents Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 29, 2016