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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 89
Healthy Volunteers: f
View:

• Access to a home desktop or laptop computer or tablet at acceptable internet speed for the study duration.

• Participants need to be 55 to 89 years of age (inclusive) at the time of informed consent.

• Females need to be post-menopausal (last period more than 12 months earlier by history).

• Subjective cognitive complaints, i.e., memory or other cognitive complaints, e.g., naming/language.

• 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 with 16 or more years of education. LMCI is defined by a WMS-III Logical Memory delayed recall score ≤ 2 with 0-7 years of education, score ≤ 4 with 8-15 years of education, and score ≤ 8 with ≥ 16 years of education.

• Montreal Cognitive Assessment (MoCA) score ≥ 20/30.

• An informant (relative, friend, other caregiver) who contacts the participant at least weekly is required to provide information about the participant's functioning. This can be a telephone informant in the case of participants who do not have a live-in informant or close significant other. If the informant drops out, an alternate informant can be designated by the participant but the new informant will need to sign the informant information sheet in person.

• Must be English-speaking: Wide Range Achievement Test (WRAT3) score must indicate at least a 6th grade reading level with a score of ≥ 37.

Locations
United States
Florida
University of Miami Miller School of Medicine
RECRUITING
Miami
North Carolina
Duke University Medical Center
RECRUITING
Durham
New York
Columbia University Irving Medical Center
RECRUITING
New York
Washington
University of Washington
RECRUITING
Seattle
Contact Information
Primary
Cileyn Herrera, BA
ch3223@cumc.columbia.edu
6467746739
Backup
Davangere P Devanand, MD, MBBS
dpd3@cumc.columbia.edu
6467748658
Time Frame
Start Date: 2024-12-17
Estimated Completion Date: 2029-02-28
Participants
Target number of participants: 240
Treatments
Placebo_comparator: Control
This sample will receive health education. The participant will read chapters from the book, Living a Healthy Life with chronic conditions, 5th edition, by K Lorig, D Laurent, V Gonzalez, D Sobel, M Minor and M Gecht-Silver, and review chapters with the unblinded study coordinator.
Active_comparator: Low Dose Crossword
This sample will receive low dose crossword training with one crossword puzzle per week during the first 12 weeks on the Cognifit web-based platform. Subsequent booster sessions will occur at 20, 32, 42, 52, 64 and 78 weeks.
Active_comparator: High Dose Crossword
This sample will receive high dose crossword training. This sample will receive high dose crossword training with four crossword puzzles per week during the first 12 weeks on the Cognifit web-based platform, followed by booster sessions at 20, 32, 42, 52, 64 and 78 weeks.
Related Therapeutic Areas
Sponsors
Leads: Columbia University
Collaborators: National Institute on Aging (NIA)

This content was sourced from clinicaltrials.gov