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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ispronicline (nicotinic acetylcholine receptor agonist) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pivotal Research Center | Mesa | Arizona | 85210 | United States | ||
| Pivotal Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20542923 | Derived | 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. |
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| 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 | Saint 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 |
| ID | Term |
|---|---|
| D008569 | Memory Disorders |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C490152 | ispronicline |
| D018722 | Nicotinic Agonists |
| ID | Term |
|---|---|
| D018679 | Cholinergic Agonists |
| D018678 | Cholinergic Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
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