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Augmenting Cognitive Training In Older Adults

2016-08-02 05:53:24 | BioPortfolio

Summary

A randomized two-phase clinical trial will enroll 360 participants with age-related cognitive decline, but not Alzheimer's disease or other neurodegenerative diseases (MoCA>25). Cognitively healthy elderly adults will undergo a CT intervention or education training-control (TC) condition in combination with transcranial direct current stimulation (tDCS) or sham tDCS control. The CT intervention will employ a suite of adaptive training tasks (Double Decision - Useful Field of View, Card Shark - Working Memory, and Freeze Frame - Arousal-Alerting) from the POSIT Science Brain HQ6, a well validated CT method for enhancing cognitive functioning in the elderly. TC will involve exposure to educational nature videos and related content questions of the same interval and duration as CT, providing a well-matched active control. Participants will receive CT or TC in conjunction with tDCS or sham/placebo prefrontal stimulation administered during training. Participants will be assessed at baseline, after CT (12 weeks), and at 12-month follow-up. At each time point, a comprehensive neurocognitive, clinical and multimodal neuroimaging assessment of brain function, metabolic state, and brain structure will be conducted. Functional magnetic resonance imaging (FMRI) will be used to assess brain response during working memory, attention and memory encoding. Proton magnetic resonance spectroscopy (MRS) will assess cerebral metabolites and gamma-aminobutyric acid (GABA) concentrations. GABA concentrations from MRS will provide a sensitive marker of neuro-plastic change in task-associated brain regions. Alzheimer's disease risk factors (APOE4, familial history), baseline clinical/demographic characteristics (e.g., diabetes), and neuroimaging biomarkers (e.g., white matter abnormality load) will assess factors with predictive value for individual response to tDCS and CT. Based on power analyses of intervention effects, 80 participants will be randomized to the four treatment conditions in phase 1. Following the intervention, CT (n=40) and TC (n=40) conditions will be compared. Interim analyses aimed at showing that CT has previously established strong effects on cognitive outcomes will be performed, thereby enabling elimination of the TC condition. Phase 2 will enroll the remaining 280 participants into the two CT intervention conditions.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Aging

Intervention

Cognitive Training, tDCS (active stimulation), tDCS (sham stimulation), Educational Training

Location

University of Florida Institute on Aging
Gainesville
Florida
United States
32610

Status

Not yet recruiting

Source

University of Florida

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-08-02T05:53:24-0400

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