Mild Cognitive Impairment Clinical Trial
Official title:
The Effect of Fit Brains Training on Cognitive Performance in Older Adults
NCT number | NCT02564809 |
Other study ID # | H14-02438 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2016 |
Est. completion date | September 2018 |
Verified date | May 2019 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators will conduct a 8-week proof-of-concept randomized controlled trial to provide preliminary evidence of efficacy of Fit Brains (Rosetta Stone Canada) training -- a mobile cognitive training program -- on cognitive and brain plasticity in older adults. The investigators will also explore whether Fit Brains training paired with a brief bout of exercise would enhance the potential cognitive benefits of Fit Brains. In addition, the investigators will explore the long-term effects of cognitive training by performing a 1-year follow-up measurement (i.e., 1-year after study completion).
Status | Completed |
Enrollment | 123 |
Est. completion date | September 2018 |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years to 85 Years |
Eligibility |
Inclusion Criteria: - aged between 65 and 85 years - completed high school education - live in their own home - read, write, and speak English with acceptable visual and auditory acuity - have preserved general cognitive function as indicated by a Mini-Mental State Examination score - score > 6/8 on the Lawton and Brody Instrumental Activities of Daily Living Scale - are not expected to start or are stable on a fixed dose of anti-dementia medications (e.g., donepezil, galantamine, etc.) during the 8-week study period - are able to walk independently; - are suitable to engage in 15-minutes of brisk walking based on the Physical Activity Readiness Questionnaire; and - provide a personally signed and dated informed consent document indicating that the individual has been informed of all pertinent aspects of the study. Exclusion Criteria: - diagnosed with dementia of any type - clinically suspected to have neurodegenerative disease as the cause of MCI that is not AD, vascular dementia (VaD), or both (e.g. multiple sclerosis, Parkinson's disease, Huntington's disease, fronto-temporal dementia, etc.) - have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility, as determined by his/her family physician - taking medications that may negatively affect cognitive function, such as anticholinergics, including agents with pronounced anticholinergic properties (e.g., amitriptyline), major tranquilizers (i.e., typical and atypical antipsychotics), and anticonvulsants (e.g., gabapentin, valproic acid, etc.) - planning to participate, or already enrolled in, a concurrent clinical drug trial Specific exclusion criteria for the MRI subset: - Participants do not meet the specific scanning requirements of the UBC MRI Research Centre. Specifically, the investigators will exclude anyone with: pacemaker, brain aneurysm clip, cochlear implant, surgery or tattoos within the past 6 weeks, electrical stimulator for nerves or bones, implanted infusion pump, history of any eye injury involving metal fragments, artificial heart valve, orthopedic hardware, other metallic prostheses, coil, catheter or filter in any blood vessel, ear or eye implant, bullets, or other metallic fragments. |
Country | Name | City | State |
---|---|---|---|
Canada | Djavad Mowafaghian Centre for Brain Health & Centre for Hip Health and Mobility | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | Mitacs |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in episodic memory as measured with the Rey Auditory Verbal Learning Test (RAVLT) at 8 weeks and 1-year follow-up | Measured by the Rey Auditory Verbal Learning Test (RAVLT) | Measured at baseline and at program completion (8 weeks), and 1-year follow-up | |
Secondary | Change from baseline in response inhibition as measured with the stroop test at 8 weeks and 1-year follow-up | Measured by Standard Neuropsychological Tests and the NIH Toolbox | Measured at baseline and at program completion (8 weeks), and 1-year follow-up | |
Secondary | Change from baseline in set shifting as measured with the Trailmaking A and B test at 8 weeks and 1-year follow-up | Measured by Standard Neuropsychological Tests and the NIH Toolbox | Measured at baseline and at program completion (8 weeks), and 1-year follow-up | |
Secondary | Change from baseline in working memory as measured with the digits forward and backward test at 8 weeks and 1-year follow-up | Measured by Standard Neuropsychological Tests and the NIH Toolbox | Measured at baseline and at program completion (8 weeks), and 1-year follow-up | |
Secondary | Change from baseline in functional capacity as measured by the 6-Minute Walk Test at 8 weeks and 1-year follow-up | Measured by the 6-Minute Walk Test | Measured at baseline and at program completion (8 weeks), and 1-year follow-up | |
Secondary | Change from baseline in mobility as measured by the Short Physical Performance Battery (SPPB) at 8 weeks | Measured by the Short Physical Performance Battery | Measured at baseline and at program completion (8 weeks). | |
Secondary | Change from baseline in brain structure as measured by structural MRI at 8 weeks | Measured by structural MRI | Measured at baseline and at program completion (8 weeks). | |
Secondary | Change from baseline in brain function as measured by resting state functional MRI at 8 weeks | Measured by resting state functional MRI | Measured at baseline and at program completion (8 weeks). |
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