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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG045163 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The current study will test the effectiveness of a computerized cognitive training program on auditory memory and attention in patients with mild cognitive impairment. Practice effects will also be examined as a moderator of treatment response.
The current study will test the effectiveness of a computerized cognitive (thinking) training program on improving thinking and memory in patients with mild cognitive impairment. The investigators will also examine how short term changes in thinking abilities (i.e., practice effects) can be related to improvement in thinking abilities after the cognitive training program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental cognitive training | Experimental | Participants will use experimental computerized cognitive training exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. |
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| control cognitive exercises | Active Comparator | Participants will use control computerized cognitive activities, 1 hour per day, 3 - 5 days per week, for 13 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| computerized cognitive exercises | Behavioral | Each group will perform computerized cognitive exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. The experimental group will use exercises shown to improve cognition, whereas the comparator group will use exercises without clear beneficial findings. |
| Measure | Description | Time Frame |
|---|---|---|
| Auditory Memory Attention Index | This is a composite of six subtests of the Repeatable Battery for the Assessment of Neuropsychological Status. It is a standard score (mean=100, standard deviation=15), with a range of approximately 45 - 145, with higher scores indicating better outcome. | 13 weeks |
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Inclusion Criteria:
Mild Cognitive Impairment, amnestic subtype
Access to internet 3 hours per week
Adequate vision, hearing, and motor responding to participate in training
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Duff, PhD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Center for Alzheimer's Care, Imaging and Research | Salt Lake City | Utah | 84108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33783254 | Derived | Duff K, Ying J, Suhrie KR, Dalley BCA, Atkinson TJ, Porter SM, Dixon AM, Hammers DB, Wolinsky FD. Computerized Cognitive Training in Amnestic Mild Cognitive Impairment: A Randomized Clinical Trial. J Geriatr Psychiatry Neurol. 2022 May;35(3):400-409. doi: 10.1177/08919887211006472. Epub 2021 Mar 30. |
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Other researchers can contact the PI to request copies of the study data.
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51 individuals were enrolled in the study but were withdrawn by the research team because they did not meet criteria for amnestic Mild Cognitive Impairment on objective testing.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Cognitive Training | Participants will use experimental computerized cognitive training exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. computerized cognitive exercises: Each group will perform computerized cognitive exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. The experimental group will use exercises shown to improve cognition, whereas the comparator group will use exercises without clear beneficial findings. |
| FG001 | Control Cognitive Exercises | Participants will use control computerized cognitive activities, 1 hour per day, 3 - 5 days per week, for 13 weeks. computerized cognitive exercises: Each group will perform computerized cognitive exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. The experimental group will use exercises shown to improve cognition, whereas the comparator group will use exercises without clear beneficial findings. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Short-term Effectiveness (~13 Weeks) |
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| Long Term Effectiveness (~1 Year) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Cognitive Training | Participants will use experimental computerized cognitive training exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. computerized cognitive exercises: Each group will perform computerized cognitive exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. The experimental group will use exercises shown to improve cognition, whereas the comparator group will use exercises without clear beneficial findings. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Auditory Memory Attention Index | This is a composite of six subtests of the Repeatable Battery for the Assessment of Neuropsychological Status. It is a standard score (mean=100, standard deviation=15), with a range of approximately 45 - 145, with higher scores indicating better outcome. | Mixed effects model | Posted | Mean | Standard Deviation | standard score units | 13 weeks |
|
approximately 13 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 | Experimental Cognitive Training | Participants will use experimental computerized cognitive training exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. computerized cognitive exercises: Each group will perform computerized cognitive exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. The experimental group will use exercises shown to improve cognition, whereas the comparator group will use exercises without clear beneficial findings. |
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underpowered
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Duff | University of Utah | 8015859983 | kevin.duff@hsc.utah.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 19, 2015 | Apr 28, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| screen fail |
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| NOT COMPLETED |
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| BG001 | Control Cognitive Exercises | Participants will use control computerized cognitive activities, 1 hour per day, 3 - 5 days per week, for 13 weeks. computerized cognitive exercises: Each group will perform computerized cognitive exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. The experimental group will use exercises shown to improve cognition, whereas the comparator group will use exercises without clear beneficial findings. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| one week practice effects | This measure indicates how much a participant improves from baseline to one week on a composite of seven cognitive scores (i.e., practice effects). The practice effects on the seven cognitive scores are averaged to get the composite. The presented value is a z-score, which has a theoretical mean of 0 and a standard deviation of +/-1. Expected range should be approximately -4 to +4. Higher scores indicate better than expected practice effects compared to normative data. Participants are not assigned to an intervention until after this one week score is collected. This is not an outcome measure. | Mean | Standard Deviation | z-score units |
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| OG001 | Control Cognitive Exercises | Participants will use control computerized cognitive activities, 1 hour per day, 3 - 5 days per week, for 13 weeks. computerized cognitive exercises: Each group will perform computerized cognitive exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. The experimental group will use exercises shown to improve cognition, whereas the comparator group will use exercises without clear beneficial findings. |
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| 2 |
| 73 |
| 0 |
| 73 |
| 0 |
| 73 |
| EG001 | Control Cognitive Exercises | Participants will use control computerized cognitive activities, 1 hour per day, 3 - 5 days per week, for 13 weeks. computerized cognitive exercises: Each group will perform computerized cognitive exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. The experimental group will use exercises shown to improve cognition, whereas the comparator group will use exercises without clear beneficial findings. | 0 | 73 | 0 | 73 | 0 | 73 |
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