Clinical Trial: Effects of Atomoxetine in Mild Cognitive Impairment

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A 6 Month, Phase II Randomized, Double-Blind, Placebo Controlled, Flexible Dosing, Crossover Trial of Atomoxetine in Subjects With Mild Cognitive Impairment.

Brief Summary:

The purpose of this study is to find out if atomoxetine causes a change in the biologic markers (substances that may indicate the presence of a disease) in the cerebrospinal fluid (CSF) of participants diagnosed with Mild Cognitive Impairment (MCI). In this research study, the spinal fluid of subjects with MCI who take atomoxetine will be compared to spinal fluid of those who take capsules containing inactive material, also known as placebo. At the six-month timepoint, subjects who were taking placebo during the first six months will be placed on active study medication, and those who received active study medication will be reassigned to placebo. After completion of the study, subjects will be able to receive open-label atomoxetine.

This study will also evaluate if the drug is safe and well-tolerated. Additionally, information will be gathered to identify the dose of atomoxetine that is most beneficial, and how taking this medication affects thinking and behavior, as well as imaging and blood biomarkers. The results of this research will help determine if atomoxetine alters signs of inflammation and other biomarkers associated with Alzheimer's disease.


Detailed Summary:
Sponsor: Emory University

Current Primary Outcome:

  • Cerebrospinal fluid biomarkers of inflammation [ Time Frame: 6 months ]
  • Biomarkers of noradrenergic function [ Time Frame: 6 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of Adverse Events [ Time Frame: 6 months ]
  • Cerebrospinal fluid biomarkers of neurodegeneration [ Time Frame: 6 months ]
  • Imaging biomarkers of neurodegeneration [ Time Frame: 6 months ]
  • Cognitive measures [ Time Frame: 6 months ]
  • Behavioral symptoms [ Time Frame: 6 months ]


Original Secondary Outcome: Same as current

Information By: Emory University

Dates:
Date Received: January 25, 2012
Date Started: March 2012
Date Completion: December 2017
Last Updated: January 3, 2017
Last Verified: January 2017