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

Study Overview
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Brief Summary
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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.

Official Title
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A Safety and Efficacy Study of TC-1734-112 in Subjects With Age Associated Memory Impairment (AAMI)

Conditions
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Age-Related Memory Disorders

Intervention / Treatment
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* Drug: ispronicline (nicotinic acetylcholine receptor agonist)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ispronicline (nicotinic acetylcholine receptor agonist)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AAMI, Memory Impairment, Decline in Cognitive Function, Age Associated Memory Impairment