Age-Related Memory Disorders
Conditions
Keywords
AAMI, Memory Impairment, Decline in Cognitive Function, Age Associated Memory Impairment
Brief summary
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.
Interventions
DRUGispronicline (nicotinic acetylcholine receptor agonist)
Sponsors
Targacept Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
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.
Design outcomes
Primary
| Measure | 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. | — |
Countries
United States
Outcome results
None listed