Phase 4
N=100
Remediation of Age-related Cognitive Decline: Vortioxetine and Cognitive Training
Age-related Cognitive Decline
Bottom Line
View on ClinicalTrials.gov: NCT03272711 ↗Enrolled (actual)
100
Serious AEs
2.0%
Results posted
Jan 2020
Primary outcome: Primary: Change in Total Fluid Cognitive Score — 6.14; 3.71; 106.06; 105.85 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Vortioxetine 10 mg (Drug); Cognitive training program (Behavioral)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total Fluid Cognitive Score |
6.14; 3.71; 8.24; 3.93; 7.55; 6.05 | — |
| SECONDARY Change in Total Fluid Cognitive Score |
6.14; 3.71; 8.24; 3.93; 7.55; 6.05 | — |
| SECONDARY Participant Function |
2.91; 1.66; 84.50; 82.44 | — |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT03272711). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.