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

Phase 4

Completed

• Conditions: Age-related Cognitive Decline
• Interventions: Drug: Vortioxetine 10 mg; Behavioral: Cognitive training program

• Registration Number: NCT03272711
• Lead Sponsor: Washington University School of Medicine

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, attention, and concentration. This study will compare the effectiveness of vortioxetine plus cognitive training versus placebo plus cognitive training.

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, attention, and concentration. This study will compare the effectiveness of vortioxetine plus cognitive training versus placebo plus cognitive training.

Vortioxetine is considered investigational when used as a treatment for age-related cognitive decline, which means that it has not been approved by the U.S. Food and Drug Administration for this purpose. Vortioxetine is approved by the U.S. Food and Drug Administration as a treatment for depression, and also goes by the name Trintellix (formerly known as Brintellix). That means that, while the drug itself is approved by the FDA, it is not approved for the reasons the investigators are using it in this study.

Participation in this study entails an estimated 6 study visits over the course of approximately six months. Participants will complete various assessments at our lab at the Washington University School of Medicine along with check-in visits in-person or over the phone. Additionally, they will participate in at home computerized cognitive training for approximately six months, supplemented with either vortioxetine or placebo.

The investigators will assess memory and problem-solving abilities using paper and pencil, computerized measures, and self-assessments of how participants feel. These tests could include numbers, letters, symbols, words, or sentences. These tests will be repeated throughout the study. If eligible to do so, participants will complete a baseline MRI scan.

A subset of participants who completed a baseline MRI scan will complete another MRI scan after approximately 26 weeks of vortioxetine or placebo and at home computerized cognitive training.

Study Timeline

• Study Start: 2016-08-31
• Study First Submitted: 2017-09-01
• Study First Submitted QC: 2017-09-01
• Study First Posted: 2017-09-05
• Primary Completion: 2019-01-24
• Study Completion: 2019-01-24
• Status Verified: 2019-12
• Results First Submitted: 2019-12-02
• Results First Submitted QC: 2019-12-27
• Last Update Submitted: 2019-12-27
• Results First Posted: 2020-01-14
• Last Update Posted: 2020-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vortioxetine plus cognitive training	Cognitive training program	Vortioxetine (10 mg) plus cognitive training 5 times weekly for 30 minutes a day
Vortioxetine plus cognitive training	Vortioxetine 10 mg	Vortioxetine (10 mg) plus cognitive training 5 times weekly for 30 minutes a day
Placebo plus cognitive training	Cognitive training program	Placebo plus cognitive training 5 times weekly for 30 minutes a day

Primary Outcome Measures

Name	Time	Method
Change in Total Fluid Cognitive Score	Randomization (0 weeks), 4 weeks	Total fluid cognitive score from the NIH Toolbox as well as the speed of cognitive improvement The study utilized five cognitive tests from the NIH Toolbox Cognitive Battery that measured "fluid" cognition-the capacity for new learning and information processing. A higher score indicates indicates better performance on these tests. A total fluid cognitive score at or near 100 indicates ability that is average compared with others nationally. Scores around 115 suggest above-average fluid cognitive ability, while scores around 130 suggest superior ability. Conversely, a score around 85 suggests below-average fluid cognitive ability, and a score in the range of 70 or below suggests significant impairment.

Secondary Outcome Measures

Name	Time	Method
Change in Total Fluid Cognitive Score	Randomization (0 weeks), 4 week, 12 week, 26 week	Total fluid cognitive score from the NIH Toolbox as well as the speed of cognitive improvement The study utilized five cognitive tests from the NIH Toolbox Cognitive Battery that measured "fluid" cognition-the capacity for new learning and information processing. A higher score indicates indicates better performance on these tests. A total fluid cognitive score at or near 100 indicates ability that is average compared with others nationally. Scores around 115 suggest above-average fluid cognitive ability, while scores around 130 suggest superior ability. Conversely, a score around 85 suggests below-average fluid cognitive ability, and a score in the range of 70 or below suggests significant impairment.
Participant Function	Randomization (0 weeks), 26 weeks	Participant function assessed using the UCSD Performance-Based Skills Assessment (UPSA).; A validated test that required participants to demonstrate their competence to perform everyday functioning tasks in domains such as comprehension, planning, finances, transportation and communication. A higher scores indicates a better outcome. Scores can range from a minimum of 0 to a maximum of 100.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States