Mild Cognitive Impairment Clinical Trial
— CBIOfficial title:
Impact of Combined Behavioral Interventions on Cognitive Outcomes in MCI
Verified date | January 2020 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Vast evidence supports use of physical exercise and cognitive stimulation for lowering risk for cognitive decline and dementia, with combinations of non-pharmacological interventions providing greatest promise for impacting cognitive aging. This, paired with limited cognitive benefits from pharmacological interventions in dementia, has shifted focus to non-pharmacological interventions administered earlier in the disease course. This application, therefore, proposes a randomized controlled trial (RCT; 12-week active intervention, 3- and 6-month follow-up) comparing 3 conditions: walking program (guided progressive increases in weekly step counts), computer-based cognitive training program (Brain HQ, Posit Science), and combination of the exercise and cognitive program, on cognitive, functional, and diagnostic outcomes in 60 sedentary, community-dwelling adults with mild cognitive impairment (MCI).
Status | Completed |
Enrollment | 52 |
Est. completion date | October 2018 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years to 80 Years |
Eligibility |
Inclusion Criteria: - MCI diagnosis (can be self referral, will determine eligibility at baseline) Exclusion Criteria: - Dementia diagnosis - Head trauma - Neuro/psychiatric disorders - Current substance dependence - Sensory/mobility deficits - No more than 1 hour of purposeful, aerobic activity/week - Currently engaging in any other brain-stimulating computer program (No more than 1 hour a week) |
Country | Name | City | State |
---|---|---|---|
United States | UCSD | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego | Alzheimer's Association |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rivermead Behavioral Memory Test | The Rivermead Behavioral Memory Test (RBMT) is an ecologically valid assessment of cognitive functioning that tests some skills specifically trained in the CT condition (e.g., name learning, and story learning) but also additional untrained skills such as prospective memory. Belongings subtest scaled scores: Minimum score = 1, Maximum score = 19; higher values represent better performance. | 12 weeks | |
Primary | Everyday Cognition Scale | The Everyday Cognition Scale (ECog) assesses (via informant report) everyday cognitive functioning in memory, language, visuospatial, and executive functioning domains. Average total score was used: Minimum = 1, Maximum = 4, higher scores indicate greater impairment | 12 weeks | |
Primary | Older Peoples Quality of Life Questionnaire | Self report assessment of quality of life specific to older adults. Assessment covers life overall, health, social relationships and participation, independence, control over life and freedom, home and neighborhood, psychological and emotional well-being, financial circumstances, leisure/activities, and culture and religion. Total score minimum = 35, max = 175; lower scores indicate better quality of life. | 12 weeks |
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