Overview

Remediation of Age-related Cognitive Decline: Vortioxetine and Cognitive Training

Status:
Completed
Trial end date:
2019-01-24
Target enrollment:
0
Participant gender:
All
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, attention, and concentration. This study will compare the effectiveness of vortioxetine plus cognitive training versus placebo plus cognitive training.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Washington University School of Medicine
Collaborators:
Queen's University
Takeda
Treatments:
Vortioxetine
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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)