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:
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
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
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:
|
Nicotinic Agonists Cholinergic Agents Cholinergic Agonists Molecular Mechanisms of Pharmacological Action |
Neurotransmitter Agents Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on March 03, 2015