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

Conditions

• Cognitive Training
• Mild Cognitive Impairment (MCI)

Eligibility Criteria

Sex

ALL

Age

55 Years - 89 Years

Healthy Volunteers

Not accepted

Interventions

• Cognitive Training — OTHER
  Participants (n=240) will be randomized to high dose crosswords, low dose crosswords, and health education at 1:1:1 ratio, stratified by site, age (\< 70 and 70 years), and MCI status (early MCI and late MCI). In the two crossword puzzles conditions, after initial training to use the web-based platform, the participant will be assigned to do 12 weeks of crossword puzzles four times per week or 12 weeks of crossword puzzles once per week at home. After these 12 weeks, booster sessions will be either four or one 30-minute session(s) completed over 1 week. These booster sessions will occur at weeks 20, 32, 42, 52, 64, and 78. In-person assessments will occur at 0, 12, 32, 52, 78 weeks with one crossword puzzle session, which will count toward the booster session. Health education will involve reading chapters in a book on common illnesses and lifestyle, and a research staff member will review these chapters at the same assessment intervals as the crossword puzzles conditions.

Study Details

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.

Key Dates

Start date

Dec 17, 2024

Status verified

Jun 2025

Primary completion

Feb 28, 2029

Completion

Feb 28, 2029

Study Design

Enrollment

240 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Change in ADASCog-14 (14-item Alzheimer's Disease Assessment Scale - Cognitive subscale) [ Time Frame: Baseline, 78 weeks ]

Central Contacts

• Lola Nedic, BA
  6467747202
  [email protected]
• Davangere P Devanand, MD, MBBS
  6467748658
  [email protected]

Locations (4)

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