Clinical trial NCT00109564: A Safety and Efficacy Study of Ispronicline (TC-1734-112) in Subjects With Age Associated Memory Impairment (AAMI)
Official title: A Safety and Efficacy Study of TC-1734-112 in Subjects With Age Associated Memory Impairment (AAMI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Age-Related Memory Disorders
Keywords: AAMI
Memory Impairment
Decline in Cognitive Function
Age Associated Memory Impairment
Lead sponsor: Targacept Inc.
Sponsor class: INDUSTRY
First posted: 2005-04-29
Enrollment: 174
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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.
measure: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Pivotal Research Center
state: Arizona
city: Peoria
country: United States
facility: Pivotal Research Center
state: Arizona
city: Denver
country: United States
facility: Radiant Research
state: Colorado
city: Fort Meyers
country: United States
facility: Neuropsychiatric Research Center of SW Florida
state: Florida
city: St. Petersberg
country: United States
facility: Meridien Research
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Decatur
country: United States
facility: Northlake Medical Research Center
state: Georgia
city: Florence
country: United States
facility: Hartford Research
state: Kentucky
city: Minneapolis
country: United States
facility: Berman Center
state: Minnesota
city: St. Louis
country: United States
facility: Radiant Research
state: Missouri
city: Greensboro
country: United States
facility: Kulynych Research Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Philadelphia
country: United States
facility: Radiant Research Philadelphia
state: Pennsylvania
city: San Antonio
country: United States
facility: Radiant Research
state: Texas
city: Salt Lake City
country: United States
facility: Radiant Research
state: Utah
Study officials:
References:
citation: 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.