Trial record 10 of 12 for:
azd3480
A Safety and Efficacy Study of Ispronicline (TC-1734-112) in Subjects With Age Associated Memory Impairment (AAMI)
This study has been completed.
Sponsor:
Targacept Inc.
Information provided by:
Targacept Inc.
ClinicalTrials.gov Identifier:
NCT00109564
First received: April 28, 2005
Last updated: July 17, 2008
Last verified: July 2008
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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 |
| 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
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:
No publications provided by Targacept Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013