CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 39 enrolled
Drug / intervention
Atomoxetine +1 moredrug
Likely dose
Atomoxetine 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01522404
NCT01522404Phase 2Completed

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

Emory University·interventional·Posted Jan 31, 2012·Updated Jul 23, 2019

In Brief

A Phase 2 clinical trial evaluating Atomoxetine and Placebo for Mild Cognitive Impairment. Completed, enrolled 39 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the safety of atomoxetine and its effect primarily on 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). 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 study will also explore rates of change in biomarkers of neurodegeneration (Aß, tau, brain atrophy rates). The results of this research will help determine if atomoxetine alters signs of inflammation and other biomarkers associated with Alzheimer's disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 31, 2012
Enrollment StartMar 1, 2012
Primary CompletionOct 31, 2017
Study CompletionJun 30, 2018
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 14.4 years ago

Interventions

Atomoxetinedrug

Subjects in this intervention will receive Atomoxetine up to 29 weeks, crossover, dose escalating (up to a maximum dose of 100 mg per day) of oral atomoxetine

Placebodrug

Subjects in this intervention will receive inactive compound up to weeks 29 and will cross over to the other group