Remediation of Age-related Cognitive Decline: Vortioxetine and Cognitive Training (BBS)
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| ClinicalTrials.gov Identifier: NCT03272711 |
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Recruitment Status :
Completed
First Posted : September 5, 2017
Results First Posted : January 14, 2020
Last Update Posted : January 14, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Age-related Cognitive Decline | Drug: Vortioxetine 10 mg Behavioral: Cognitive training program | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 129 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Remediation of Age-related Cognitive Decline: Vortioxetine and Cognitive Training |
| Actual Study Start Date : | August 31, 2016 |
| Actual Primary Completion Date : | January 24, 2019 |
| Actual Study Completion Date : | January 24, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Vortioxetine plus cognitive training
Vortioxetine (10 mg) plus cognitive training 5 times weekly for 30 minutes a day
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Drug: Vortioxetine 10 mg
Other Name: Trintellix Behavioral: Cognitive training program Online training program, 30 minutes a day, 5 times a week |
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Placebo Comparator: Placebo plus cognitive training
Placebo plus cognitive training 5 times weekly for 30 minutes a day
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Behavioral: Cognitive training program
Online training program, 30 minutes a day, 5 times a week |
- Change in Total Fluid Cognitive Score [ Time Frame: 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.
- Change in Total Fluid Cognitive Score [ Time Frame: 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 [ Time Frame: 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 65 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03272711
| United States, Missouri | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
| Principal Investigator: | Eric Lenze, MD | Washington University School of Medicine |
Documents provided by Washington University School of Medicine:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT03272711 |
| Other Study ID Numbers: |
201509107 |
| First Posted: | September 5, 2017 Key Record Dates |
| Results First Posted: | January 14, 2020 |
| Last Update Posted: | January 14, 2020 |
| Last Verified: | December 2019 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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