The Use of Duloxetine for Cognition Improvement in Individuals With Mild Cognitive Impairment (DEMO)
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|ClinicalTrials.gov Identifier: NCT02590874|
Recruitment Status : Completed
First Posted : October 29, 2015
Last Update Posted : October 11, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment Depression||Drug: Duloxetine Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Depression and Memory Trial|
|Actual Study Start Date :||January 2016|
|Actual Primary Completion Date :||July 2017|
|Actual Study Completion Date :||October 2018|
Experimental: Duloxetine group
Active drug group
Duloxetine 30 mg per day for 2 weeks. Duloxetine 60 mg per day for 4 months. Duloxetine 30 mg per day for 2 weeks.
Other Name: Cymbalta
Placebo Comparator: Placebo group
Inactive drug group
Placebo 30 mg per day for 2 weeks. Placebo 60 mg per day for 4 months. Placebo 30 mg per day for 2 weeks.
Other Name: Avicel
- Change in scores for the Repeatable Battery for Neuropsychological Status (RBANS) from baseline to 16 weeks. [ Time Frame: Weeks 0 and 16 ]RBANS measures immediate memory, visuospatial construction, attention processes and speed of information processing, expressive and receptive language, and delayed memory.
- Evaluation of the relative dominance of the verbal-reading system from baseline at 16 weeks through the Stroop Color and Word Test [ Time Frame: Weeks 0 and 16 ]The Stroop is associated with cognitive flexibility, resistance to interference from outside stimuli, creativity, and psychopathology
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|Ages Eligible for Study:||50 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Male or female, age 50 and up.
- Female participants must be post-menopausal for at least two consecutive years.
- Health and Aging Brain Study participant, who provided consent for re-contact
- Diagnosis of MCI (by Health and Aging Brain Study Consensus Review).
- Has an elevated DepE score (2 or more). This is calculated by summing scores for five items (Items 14, 16, 17,25 &26) on the Geriatric Depression Scale.
- Inability to provide informed consent by self or by proxy.
- Pregnant or breast feeding women
- Uncontrolled narrow angle glaucoma
- Known hypersensitivity to duloxetine.
- Participation in a Clinical Trial in the last three months.
- Other psychiatric disorder like bipolar disorder, schizophrenia, or dementia.
- Use of antidepressants, anti-psychotics, and mood stabilizers.
- History of stroke.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02590874
|United States, Texas|
|University of North Texas Health Science Center|
|Fort Worth, Texas, United States, 76107|
|Principal Investigator:||Leigh Johnson, PhD||University of North Texas Health Science Center|
|Responsible Party:||Leigh Johnson , PhD, LMSW, Assistant Professor, University of North Texas Health Science Center|
|Other Study ID Numbers:||
|First Posted:||October 29, 2015 Key Record Dates|
|Last Update Posted:||October 11, 2018|
|Last Verified:||October 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Mild Cognitive Impairment
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Serotonin and Noradrenaline Reuptake Inhibitors
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Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
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