Age-related Cognitive Decline
Conditions
Keywords
Vortioxetine, Elderly, Online cognitive training
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.
Interventions
BEHAVIORALCognitive training program
Online training program, 30 minutes a day, 5 times a week
Sponsors
Queen's University
Takeda
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
Twenty-nine participants were not assigned to a group. Twenty did not meet eligibility criteria for randomization, 8 individuals declined to participate further and one person was a pilot participant.
Participants by arm
| Arm | Count |
|---|---|
| Vortioxetine Plus Cognitive Training Vortioxetine (10 mg) plus cognitive training 5 times weekly for 30 minutes a day
Vortioxetine 10 mg
Cognitive training program: Online training program, 30 minutes a day, 5 times a week | 51 |
| Placebo Plus Cognitive Training Placebo plus cognitive training 5 times weekly for 30 minutes a day
Cognitive training program: Online training program, 30 minutes a day, 5 times a week | 49 |
| Total | 100 |
Baseline characteristics
| Characteristic | Vortioxetine Plus Cognitive Training | Total | Placebo Plus Cognitive Training |
|---|---|---|---|
| Age, Continuous | 71.68 years STANDARD_DEVIATION 4.77 | 71.78 years STANDARD_DEVIATION 5.01 | 71.88 years STANDARD_DEVIATION 5.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 98 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 18 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 40 Participants | 78 Participants | 38 Participants |
| Region of Enrollment United States | 51 participants | 100 participants | 49 participants |
| Sex: Female, Male Female | 28 Participants | 51 Participants | 23 Participants |
| Sex: Female, Male Male | 23 Participants | 49 Participants | 26 Participants |
| Years of Schooling | 16.80 years STANDARD_DEVIATION 2.48 | 16.72 years STANDARD_DEVIATION 2.87 | 16.63 years STANDARD_DEVIATION 3.24 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 49 |
| other Total, other adverse events | 31 / 51 | 21 / 49 |
| serious Total, serious adverse events | 0 / 51 | 2 / 49 |
Outcome results
Primary
Change in Total Fluid Cognitive Score
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.
Time frame: Randomization (0 weeks), 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vortioxetine Plus Cognitive Training | Change in Total Fluid Cognitive Score | Change in Total Fluid Cognitive Score | 6.14 score on a scale | Standard Deviation 7.8 |
| Vortioxetine Plus Cognitive Training | Change in Total Fluid Cognitive Score | Week 4 Total Fluid Cogntive Score | 106.06 score on a scale | Standard Deviation 17.06 |
| Placebo Plus Cognitive Training | Change in Total Fluid Cognitive Score | Change in Total Fluid Cognitive Score | 3.71 score on a scale | Standard Deviation 7.27 |
| Placebo Plus Cognitive Training | Change in Total Fluid Cognitive Score | Week 4 Total Fluid Cogntive Score | 105.85 score on a scale | Standard Deviation 12.38 |
Secondary
Change in Total Fluid Cognitive Score
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.
Time frame: Randomization (0 weeks), 4 week, 12 week, 26 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vortioxetine Plus Cognitive Training | Change in Total Fluid Cognitive Score | Change at Week 4 | 6.14 score on a scale | Standard Deviation 7.8 |
| Vortioxetine Plus Cognitive Training | Change in Total Fluid Cognitive Score | Change at Week 12 | 8.24 score on a scale | Standard Deviation 7.82 |
| Vortioxetine Plus Cognitive Training | Change in Total Fluid Cognitive Score | Change at Week 26 | 7.55 score on a scale | Standard Deviation 7.95 |
| Vortioxetine Plus Cognitive Training | Change in Total Fluid Cognitive Score | Total Fluid Cognitive Score at Week 4 | 106.06 score on a scale | Standard Deviation 17.06 |
| Vortioxetine Plus Cognitive Training | Change in Total Fluid Cognitive Score | Total Fluid Cognitive Score at Week 12 | 108.12 score on a scale | Standard Deviation 16.34 |
| Vortioxetine Plus Cognitive Training | Change in Total Fluid Cognitive Score | Total Fluid Cognitive Score at Week 26 | 106.98 score on a scale | Standard Deviation 17.19 |
| Placebo Plus Cognitive Training | Change in Total Fluid Cognitive Score | Total Fluid Cognitive Score at Week 12 | 105.57 score on a scale | Standard Deviation 12.31 |
| Placebo Plus Cognitive Training | Change in Total Fluid Cognitive Score | Change at Week 4 | 3.71 score on a scale | Standard Deviation 7.27 |
| Placebo Plus Cognitive Training | Change in Total Fluid Cognitive Score | Total Fluid Cognitive Score at Week 4 | 105.85 score on a scale | Standard Deviation 12.38 |
| Placebo Plus Cognitive Training | Change in Total Fluid Cognitive Score | Change at Week 12 | 3.93 score on a scale | Standard Deviation 6.7 |
| Placebo Plus Cognitive Training | Change in Total Fluid Cognitive Score | Total Fluid Cognitive Score at Week 26 | 107.51 score on a scale | Standard Deviation 11.44 |
| Placebo Plus Cognitive Training | Change in Total Fluid Cognitive Score | Change at Week 26 | 6.05 score on a scale | Standard Deviation 8.26 |
Secondary
Participant Function
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.
Time frame: Randomization (0 weeks), 26 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vortioxetine Plus Cognitive Training | Participant Function | Change in UPSA Score | 2.91 score on a scale | Standard Deviation 7.26 |
| Vortioxetine Plus Cognitive Training | Participant Function | Total UPSA Score at Week 26 | 84.50 score on a scale | Standard Deviation 8.8 |
| Placebo Plus Cognitive Training | Participant Function | Change in UPSA Score | 1.66 score on a scale | Standard Deviation 8.73 |
| Placebo Plus Cognitive Training | Participant Function | Total UPSA Score at Week 26 | 82.44 score on a scale | Standard Deviation 8.59 |