Cognitive training and neuroplasticity in mild cognitive impairment (COG-IT): protocol for a two-site, blinded, randomised, controlled treatment trial

Abstract

IntroductionMild cognitive impairment (MCI) is common in older adults and represents a high-risk group for progression to Alzheimer’s disease (AD). Medication trials in MCI have generally failed, but new discoveries with brain plasticity in ageing have led to the study of cognitive training as a potential treatment to improve cognitive abilities. Computerised cognitive training (CCT) involves computerised cognitive exercises that target specific cognitive abilities and neural networks to potentially improve cognitive functioning through neuroplasticity.Methods and analysisIn a two-site study (New York State Psychiatric Institute/Columbia University Medical Center and Duke University Medical Center), we will randomise 100 patients with MCI (Wechsler Memory Scale-III Logical Memory II score 0–11; Folstein Mini Mental State Examination ≥23) to home-based CCT (suite of exercises: memory, matching, spatial recognition, processing speed) or a home-based active control condition (computerised crossword puzzle training (CPT)) with 12 weeks of intensive training followed by regular booster sessions up to 78 weeks. All patients will receive standard neuropsychological and functional assessments in clinic as well as structural/functional brain MRI scans at study entry and endpoint. We will test if CCT, versus CPT, leads to improved cognitive functioning, transfers to functional ability and tasks of everyday life and impacts hippocampal volume changes and changes in the default mode network of the brain measured by resting-state functional MRI.Ethics and disseminationThe study will be conducted following ethics approval and written informed consent will be obtained from all subjects. Study results will be disseminated via publication, clinicaltrials.gov, media and conference presentations. This will be the first controlled long-term trial to evaluate the effects of home-based CCT versus computerised CPT on cognitive abilities and functional measures and neural outcomes as determined by MRI indices in patients with MCI. Positive results from trial may support further development of home-based CCT.Trial registration numberClinicalTrials.gov identifier (NCT03205709).

Computerized Cognitive Training by Healthy Older and Younger Adults: Age Comparisons of Overall Efficacy and Selective Effects on Cognition

“…Other studies of cognitive aging (e.g., ACTIVE) have found beneficial effects of CCT on episodic memory. The effects of training with Lumosity in particular (vs. crossword puzzles) are currently under study in an RCT involving patients with MCI ( 29 ).…”

“…In contrast, an impact on the incidence or onset of MCI or dementia has still to be demonstrated convincingly ( 5 , 6 ). But such evidence may be forthcoming from ongoing or future RCTs [e.g., ( 29 )].…”

Validity of the Web-based, Self-directed, NeuroCognitive Performance Test in MCI

“…All subjects also underwent brain MRI. Severity of MCI was assessed by the delayed recall score of WMS-III Logical Memory as described previously (16).…”

Advancing Computerized Cognitive Training for MCI and Alzheimer's Disease in a Pandemic and Post-pandemic World

“…Alternatively a regulatory quality trial could also be conducted in the public interest through a public-private partnership involving one or more CCT companies or via a government grant. For example, our group is currently conducting an 18-month randomized trial of CCT vs. active control in carefully selected MCI patients with clinically meaningful cognitive (ADAS-Cog), functional (FAQ, UPSA), neuronal loss (hippocampal volume) and disease modifying (progression to dementia) outcomes (32).…”