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Recruiting Phase 2 NCT06601933

Cognitive Training and Neuroplasticity in Mild Cognitive Impairment: COGIT-2 Trial

Trial Parameters

Condition Mild Cognitive Impairment (MCI)
Sponsor Columbia University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 240
Sex ALL
Min Age 55 Years
Max Age 89 Years
Start Date 2024-12-17
Completion 2029-02-28
Interventions
Cognitive Training

Brief Summary

Effective, clinically meaningful treatments are lacking for patients with mild cognitive impairment (MCI), which is associated with increased risk of transition to dementia. Cognitive training represents an important therapeutic strategy. In a previous study, crossword puzzles were found to be superior to computerized cognitive training on the primary cognitive outcome and function with decreased brain atrophy. Building on these findings, this study will evaluate and compare the impact of high dose crosswords (4 puzzles per week) to low dose crosswords (1 puzzle per week) and a health education control group on the cognition and function of participants.

Eligibility Criteria

Inclusion Criteria: 1. Access to a home desktop or laptop computer or tablet at acceptable internet speed for the study duration. 2. Participants need to be 55 to 89 years of age (inclusive) at the time of informed consent. 3. Females need to be post-menopausal (last period more than 12 months earlier by history). 4. Subjective cognitive complaints, i.e., memory or other cognitive complaints, e.g., naming/language. 5. Meets criteria for cognitive impairment (CI), including either EMCI (early MCI) or LMCI (late MCI), defined as memory impairment documented by scoring below the education adjusted cutoff on the Logical Memory II subscale (Story A, Delayed Paragraph Recall) from the Wechsler Memory Scale - III (WMS-III) (the maximum score is 25). The criteria for MCI (includes EMCI and LMCI) and used in COGIT-2 are as follows: EMCI is defined by a WMS-III Logical memory delayed recall score of 3-6 with 0-7 years of education, score of 5-9 with 8-15 years of education, and score of 9-11 wit

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