The Use of Duloxetine for Cognition Improvement in Individuals With Mild Cognitive Impairment

NCT02590874 | Completed Phase 4 DMC

• 1 other identifier: UNTHSC IRB#2015-128
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether Cymbalta (duloxetine) is effective to improve cognition in individuals with Mild Cognitive Impairment.

Conditions

Mild Cognitive Impairment; Depression

Keywords

Mild Cognitive Impairment; Cognition; Memory; Depression; Depressive disorder; Antidepressive agents; Duloxetine; Cymbalta; Selective serotonin and norepinephrine uptake inhibitors

Outcome Measures

Primary Outcomes (1)

• Change in scores for the Repeatable Battery for Neuropsychological Status (RBANS) from baseline to 16 weeks.

  RBANS measures immediate memory, visuospatial construction, attention processes and speed of information processing, expressive and receptive language, and delayed memory.

  Weeks 0 and 16

Secondary Outcomes (1)

• Evaluation of the relative dominance of the verbal-reading system from baseline at 16 weeks through the Stroop Color and Word Test

  Weeks 0 and 16

Study Arms (2)

Duloxetine group

EXPERIMENTAL

Active drug group

Drug: Duloxetine

Placebo group

PLACEBO COMPARATOR

Inactive drug group

Drug: Placebo

Interventions

Duloxetine DRUG

Duloxetine 30 mg per day for 2 weeks. Duloxetine 60 mg per day for 4 months. Duloxetine 30 mg per day for 2 weeks.

Also known as: Cymbalta

Duloxetine group

Placebo DRUG

Placebo 30 mg per day for 2 weeks. Placebo 60 mg per day for 4 months. Placebo 30 mg per day for 2 weeks.

Also known as: Avicel

Placebo group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Texas Health Science Center: lead

Study Sites (1)

University of North Texas Health Science Center

Fort Worth, Texas, 76107, United States

Location

Related Publications (5)

• Johnson LA, Sohrabi HR, Hall JR, Kevin T, Edwards M, O'Bryant SE, Martins RN. A depressive endophenotype of poorer cognition among cognitively healthy community-dwelling adults: results from the Western Australia memory study. Int J Geriatr Psychiatry. 2015 Aug;30(8):881-6. doi: 10.1002/gps.4231. Epub 2014 Nov 13.

  PMID: 25394326 BACKGROUND

• Johnson LA, Hall JR, O'Bryant SE. A depressive endophenotype of mild cognitive impairment and Alzheimer's disease. PLoS One. 2013 Jul 11;8(7):e68848. doi: 10.1371/journal.pone.0068848. Print 2013.

  PMID: 23874786 BACKGROUND

• Johnson LA, Mauer C, Jahn D, Song M, Wyshywaniuk L, Hall JR, Balldin VH, O'Bryant SE. Cognitive differences among depressed and non-depressed MCI participants: a project FRONTIER study. Int J Geriatr Psychiatry. 2013 Apr;28(4):377-82. doi: 10.1002/gps.3835. Epub 2012 May 31.

  PMID: 22653735 BACKGROUND

• O'Bryant SE, Johnson L, Reisch J, Edwards M, Hall J, Barber R, Devous MD Sr, Royall D, Singh M. Risk factors for mild cognitive impairment among Mexican Americans. Alzheimers Dement. 2013 Nov;9(6):622-631.e1. doi: 10.1016/j.jalz.2012.12.007. Epub 2013 May 2.

  PMID: 23643456 BACKGROUND

• O'Bryant SE, Johnson L, Balldin V, Edwards M, Barber R, Williams B, Devous M, Cushings B, Knebl J, Hall J. Characterization of Mexican Americans with mild cognitive impairment and Alzheimer's disease. J Alzheimers Dis. 2013;33(2):373-9. doi: 10.3233/JAD-2012-121420.

  PMID: 22976076 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Depression; Depressive Disorder

Interventions

Duloxetine Hydrochloride; Cellulose

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Mood Disorders

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Leigh Johnson, PhD

  University of North Texas Health Science Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: October 29, 2015
• Study Start: January 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: October 1, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)