Back to resultsA Safety and Efficacy Study of Ispronicline (TC-1734-112) in Subjects With Age Associated Memory Impairment (AAMI)
Primary Purpose
Age-Related Memory Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ispronicline (nicotinic acetylcholine receptor agonist)
Sponsored by
About this trial
This is an interventional treatment trial for Age-Related Memory Disorders focused on measuring AAMI, Memory Impairment, Decline in Cognitive Function, Age Associated Memory Impairment
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.
Sites / Locations
- Pivotal Research Center
- Pivotal Research Center
- Radiant Research
- Neuropsychiatric Research Center of SW Florida
- Meridien Research
- Meridien Research
- Northlake Medical Research Center
- Hartford Research
- Berman Center
- Radiant Research
- Kulynych Research Center
- Wake Forest University
- Radiant Research Philadelphia
- Radiant Research
- Radiant Research
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00109564
Brief Title
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
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Targacept Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Memory Disorders
Keywords
AAMI, Memory Impairment, Decline in Cognitive Function, Age Associated Memory Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
174 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ispronicline (nicotinic acetylcholine receptor agonist)
Primary Outcome Measure Information:
Title
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.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Pivotal Research Center
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
Pivotal Research Center
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Radiant Research
City
Denver
State/Province
Colorado
ZIP/Postal Code
80212
Country
United States
Facility Name
Neuropsychiatric Research Center of SW Florida
City
Fort Meyers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Meridien Research
City
St. Petersberg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Meridien Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Northlake Medical Research Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Hartford Research
City
Florence
State/Province
Kentucky
ZIP/Postal Code
41042
Country
United States
Facility Name
Berman Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Radiant Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Kulynych Research Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Radiant Research Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19115
Country
United States
Facility Name
Radiant Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Radiant Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20542923
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.
Results Reference
derived
Links:
URL
http://www.targacept.com/
Description
Related Info
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A Safety and Efficacy Study of Ispronicline (TC-1734-112) in Subjects With Age Associated Memory Impairment (AAMI)
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