A Safety and Efficacy Study of Ispronicline (TC-1734-112) in Subjects With Age Associated Memory Impairment (AAMI)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00109564 |
Recruitment Status :
Completed
First Posted : April 29, 2005
Last Update Posted : July 18, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Age-Related Memory Disorders | Drug: ispronicline (nicotinic acetylcholine receptor agonist) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 174 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Safety and Efficacy Study of TC-1734-112 in Subjects With Age Associated Memory Impairment (AAMI) |
Study Start Date : | January 2005 |
Study Completion Date : | October 2005 |

- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | 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
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00109564
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00109564 |
Other Study ID Numbers: |
TC-1734-112-CRD-004 |
First Posted: | April 29, 2005 Key Record Dates |
Last Update Posted: | July 18, 2008 |
Last Verified: | July 2008 |
AAMI Memory Impairment Decline in Cognitive Function Age Associated Memory Impairment |
Memory Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Acetylcholine Nicotinic Agonists |
Vasodilator Agents Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |