NCT00109564

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

July 18, 2008

Status Verified

July 1, 2008

First QC Date

April 28, 2005

Last Update Submit

July 17, 2008

Conditions

Age-Related Memory Disorders

Keywords

AAMIMemory ImpairmentDecline in Cognitive FunctionAge Associated Memory Impairment

Outcome Measures

Primary Outcomes (2)

  • 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.

Interventions

ispronicline (nicotinic acetylcholine receptor agonist)DRUG

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Pivotal Research Center

Mesa, Arizona, 85210, United States

Location

Pivotal Research Center

Peoria, Arizona, 85381, United States

Location

Radiant Research

Denver, Colorado, 80212, United States

Location

Neuropsychiatric Research Center of SW Florida

Fort Meyers, Florida, 33912, United States

Location

Meridien Research

Saint Petersberg, Florida, 33709, United States

Location

Meridien Research

Tampa, Florida, 33609, United States

Location

Northlake Medical Research Center

Decatur, Georgia, 30033, United States

Location

Hartford Research

Florence, Kentucky, 41042, United States

Location

Berman Center

Minneapolis, Minnesota, 55404, United States

Location

Radiant Research

St Louis, Missouri, 63141, United States

Location

Kulynych Research Center

Greensboro, North Carolina, 27408, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Radiant Research Philadelphia

Philadelphia, Pennsylvania, 19115, United States

Location

Radiant Research

San Antonio, Texas, 78229, United States

Location

Radiant Research

Salt Lake City, Utah, 84107, United States

Location

Related Publications (1)

  • 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.

    PMID: 20542923DERIVED

MeSH Terms

Conditions

Memory Disorders

Interventions

isproniclineNicotinic Agonists

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholinergic AgonistsCholinergic AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of Drugs

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 28, 2005

First Posted

April 29, 2005

Study Start

January 1, 2005

Study Completion

October 1, 2005

Last Updated

July 18, 2008

Record last verified: 2008-07

Locations

US(15)