Mild Cognitive Impairment Clinical Trial
Official title:
Effects of Memory Boot Camp on Brain Function in Adults With Symptoms of Mild Cognitive Impairment (MCI)
NCT number | NCT04426162 |
Other study ID # | 16-127 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 5, 2017 |
Est. completion date | April 24, 2019 |
Verified date | June 2020 |
Source | Neurocore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a prospective controlled clinical trial to determine the effects of a 12-week Memory Boot Camp (MBC) program on cognitive function in older adults with symptoms of Mild Cognitive Impairment.
Status | Completed |
Enrollment | 76 |
Est. completion date | April 24, 2019 |
Est. primary completion date | April 24, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Subjective memory concerns - At least a high school education - Having a current primary care doctor (or agreement to get a primary care doctor) - Ability to read and write English - Time availability of 4-5 hours/week - Be in good general health Exclusion Criteria: - Major depression - Known neurological illness (e.g. Alzheimer's or other dementia, Parkinson's, epilepsy, multiple sclerosis) - Serious psychiatric diagnosis - Substance abuse - Complete blindness or deafness - Plans to be out of town for more than 10 days during the active phase of the trial - Current or past client of the Sponsor - Complete blindness or deafness - Employee or family member of Sponsor employee |
Country | Name | City | State |
---|---|---|---|
United States | Neurocore Brain Performance Center | Boca Raton | Florida |
United States | Neurocore Brain Performance Center | Grandville | Michigan |
United States | Neurocore Brain Performance Center | Palm Beach Gardens | Florida |
Lead Sponsor | Collaborator |
---|---|
Neurocore |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Neurotrax BrainCare Testing Suite | Neurotrax was originally developed and validated for the diagnosis of MCI in clinical practice and in research (at that time it was called "Mindstreams"). Neurotrax has been further validated since then in both demented and normally-aging populations.There are 7 domains covered by this series of tests: Memory, Executive Function (Thinking), Attention, Visual Spatial, Verbal Function, Problem Solving and Working Memory. | Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12). | |
Other | Change in Beck Depression Inventory-II (BDI) | The BDI is a twenty-one item self-report inventory, and one of the most widely used instruments for measuring severity of depression. | Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12). | |
Other | Change in Beck Anxiety Inventory (BAI) | The BAI is a twenty-one item self-report inventory, and is a widely-used instrument for measuring subjective, somatic, or panic-related symptoms of anxiety. | Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12). | |
Other | Change in Insomnia Severity Index (ISI) | The ISI is a 7-item self-report inventory. The questionnaire is designed to assess the subject's sleep patterns and presence of or severity of insomnia during a 14-day period. | Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12). | |
Other | Change in Pittsburgh Sleep Quality Index (PSQI) | The PSQI is a 19-item self-report inventory. The survey is designed to measure sleep quality and disturbances over a one-month interval in clinical populations. The nineteen items generate a global score as well as seven component scores (subjective sleep quality; sleep latency; sleep duration; habitual sleep efficacy; sleep disturbances; use of sleeping medication; daytime dysfunction). | Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12). | |
Other | Change in Work and Social Adjustment Scale (WSAS) | The WSAS is a five-item self-report inventory, which provides a measure of global functional impairment, due to memory concerns. | Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12). | |
Other | Change in Quantitative Electroencephalography (QEEG) | EEG activity will be collected 19 electrode locations, according to standard 10-20 site placement standards. Information about EEG absolute and relative power from 1 - 30 Hz will be collected at every location, as well as pairwise combinations of coherence and phase measures.Data will be compared to the Neuroguide age-normed QEEG database. | Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12). | |
Other | Change in Heart Rate Variability (HRV) | HRV parameters include mean heart rate and two common time-domain measures used to calculate HRV: the standard deviation of normal to normal beat intervals (SDNN) and the root mean square of successive normal to normal beat interval differences (RMSSD). | Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12). | |
Primary | Change in Montreal Cognitive Assessment (MoCA) | The MoCA is a validated, brief assessment tool that measures MCI and is widely used. Individuals are scored on seven different domains: visuospatial/executive, naming, attention, language, abstraction, delayed recall, and orientation. | Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12). |
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