Status:
COMPLETED
Remediation of Age-related Cognitive Decline: Vortioxetine and Cognitive Training
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Queen's University
Takeda
Conditions:
Age-related Cognitive Decline
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
The purpose of this research study is to examine the potential benefits of vortioxetine in combination with at-home computerized cognitive training program to improve cognition, such as memory, attent...
Detailed Description
The purpose of this research study is to examine the potential benefits of vortioxetine in combination with at-home computerized cognitive training program to improve cognition, such as memory, attent...
Eligibility Criteria
Inclusion
- Community-living men and women age 65 and older
- Age-related cognitive decline as defined by (a) self-reported cognitive dysfunction that is attributed to the aging process (in response to screening questions to the participant); (b) ability to complete cognitive battery, but still scoring less than 1 standard deviation above age-matched norms at both baseline and after the two-week cognitive training lead-in.
Exclusion
- Known dementia or other clinical neurodegenerative illness (e.g., Parkinson's disease, cerebrovascular disease) per self-report, informant report, medical records, or neuropsychological testing
- Any current psychiatric disorder
- Medical conditions that suggest shortened lifespan, such as metastatic cancer; or would prohibit safe participation in the interventions, including cardiovascular disease or musculoskeletal conditions; or with the assessments.
- Sensory impairment that would prevent participation
- IQ \< 70 as estimated by the Wechsler Test of Adult Reading
- Alcohol or substance abuse within 6 months
- Concurrent cognitive training, such as brain-training software, or other interventions expected to affect neuroplasticity
- Psychotropic medications or those with likely CNS effects (none within 4 weeks prior to study entry)
Key Trial Info
Start Date :
August 31 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2019
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT03272711
Start Date
August 31 2016
End Date
January 24 2019
Last Update
January 14 2020
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110