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| Name | Class |
|---|---|
| Queen's University | OTHER |
| Takeda | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vortioxetine plus cognitive training | Experimental | Vortioxetine (10 mg) plus cognitive training 5 times weekly for 30 minutes a day |
|
| Placebo plus cognitive training | Placebo Comparator | Placebo plus cognitive training 5 times weekly for 30 minutes a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortioxetine 10 mg | Drug |
|
| |
| Cognitive training program |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Randomization (0 weeks), 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Lenze, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12425704 | Background | Ball K, Berch DB, Helmers KF, Jobe JB, Leveck MD, Marsiske M, Morris JN, Rebok GW, Smith DM, Tennstedt SL, Unverzagt FW, Willis SL; Advanced Cognitive Training for Independent and Vital Elderly Study Group. Effects of cognitive training interventions with older adults: a randomized controlled trial. JAMA. 2002 Nov 13;288(18):2271-81. doi: 10.1001/jama.288.18.2271. | |
| 23896849 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo Plus Cognitive Training |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Randomization (0 weeks), 4 weeks |
|
26 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening of Coronary Artery Disease | Cardiac disorders | Systematic Assessment | Hospitalization post bypass surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Lenze | Washington University School of Medicine | 314-362-1671 | lenzee@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 23, 2016 | Dec 27, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000078784 | Vortioxetine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Behavioral |
Online training program, 30 minutes a day, 5 times a week |
|
| Randomization (0 weeks), 4 week, 12 week, 26 week |
| 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. | Randomization (0 weeks), 26 weeks |
| Bowie CR, Gupta M, Holshausen K, Jokic R, Best M, Milev R. Cognitive remediation for treatment-resistant depression: effects on cognition and functioning and the role of online homework. J Nerv Ment Dis. 2013 Aug;201(8):680-5. doi: 10.1097/NMD.0b013e31829c5030. |
| 23484795 | Background | Kozauer N, Katz R. Regulatory innovation and drug development for early-stage Alzheimer's disease. N Engl J Med. 2013 Mar 28;368(13):1169-71. doi: 10.1056/NEJMp1302513. Epub 2013 Mar 13. No abstract available. |
| 25405755 | Background | Lampit A, Hallock H, Valenzuela M. Computerized cognitive training in cognitively healthy older adults: a systematic review and meta-analysis of effect modifiers. PLoS Med. 2014 Nov 18;11(11):e1001756. doi: 10.1371/journal.pmed.1001756. eCollection 2014 Nov. |
| 32212856 | Derived | Lenze EJ, Stevens A, Waring JD, Pham VT, Haddad R, Shimony J, Miller JP, Bowie CR. Augmenting Computerized Cognitive Training With Vortioxetine for Age-Related Cognitive Decline: A Randomized Controlled Trial. Am J Psychiatry. 2020 Jun 1;177(6):548-555. doi: 10.1176/appi.ajp.2019.19050561. Epub 2020 Mar 26. |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Years of Schooling | Mean | Standard Deviation | years |
|
| OG001 | 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 |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Randomization (0 weeks), 4 week, 12 week, 26 week |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Randomization (0 weeks), 26 weeks |
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| 31 |
| 51 |
| EG001 | 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 | 0 | 49 | 2 | 49 | 21 | 49 |
|
| Hospitalization for Bacterial Infection | Infections and infestations | Systematic Assessment |
|
| viral illness | General disorders | Systematic Assessment |
|
| Rashes or pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Musculoskeletal aches | General disorders | Systematic Assessment |
|
| Dental infectkons/aches | General disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
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| Change at Week 26 |
|
| Total Fluid Cognitive Score at Week 4 |
|
| Total Fluid Cognitive Score at Week 12 |
|
| Total Fluid Cognitive Score at Week 26 |
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