Computerized Games versus Crosswords Training in Mild Cognitive Impairment.
D P Devanand, Terry E Goldberg, Min Qian...
https://pubmed.ncbi.nlm.nih.gov/37635843Actively Recruiting
Phase 2
Age: 55Years - 89Years
All Genders
ID06601933
Cognitive Training and Neuroplasticity in Mild Cognitive Impairment: COGIT-2 Trial
Led by Columbia University · Updated on 2025-10-31
240
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating cognitive training methods to help people with mild cognitive impairment (MCI), a condition linked to a higher risk of progressing to dementia. This study compares the effects of doing crossword puzzles at different doses—four puzzles per week versus one puzzle per week—against a health education control group. The goal is to see how these activities impact thinking abilities, daily functioning, brain structure, and biomarkers related to neurodegeneration and Alzheimer's disease. Participants will be randomly assigned to one of three groups: high dose crossword puzzles, low dose crossword puzzles, or health education. The crossword groups will complete their assigned puzzles over an initial 12-week period, followed by booster sessions at weeks 20, 32, 42, 52, 64, and 78. During some weeks, crossword sessions take place at home and others in the clinic. The health education group will read chapters from a health book and discuss them with study staff on a similar schedule as the crossword groups, including phone calls to match booster sessions. Participants will be assessed in person at weeks 0, 12, 32, 52, and 78, including cognitive testing, brain scans, and blood tests for biomarkers. The primary measure is the change in cognitive function using a 14-item Alzheimer's Disease Assessment Scale over 78 weeks. Secondary measures include changes in daily function, brain volume, and brain thickness. The study monitors progress and safety throughout the nearly 1.5-year participation period.
CONDITIONS
Brief Title
Cognitive Training and Neuroplasticity in Mild Cognitive Impairment: COGIT-2 Trial
Who Can Participate
Age: 55Years - 89Years
All Genders
Eligibility Criteria
You may qualify if you...
- Access to a home desktop, laptop, or tablet with acceptable internet speed for the study duration
- Age between 55 and 89 years at the time of informed consent
- Females must be post-menopausal (last period more than 12 months ago)
- Subjective cognitive complaints such as memory or language difficulties
- Meets criteria for early or late mild cognitive impairment based on specific memory test scores
- Montreal Cognitive Assessment (MoCA) score of 20 or higher out of 30
- Has an informant who contacts the participant at least weekly
- English-speaking with reading ability at least at 6th grade level (WRAT3 score of 37 or higher)
You will not qualify if you...
- Diagnosis of any type of dementia
- Current diagnosis of schizophrenia, schizoaffective disorder, psychosis, or bipolar I disorder
- Current unstable or untreated major depression or active suicidality
- Alcohol or substance use disorder within the past 6 months
- Clinical stroke with lasting neurological deficits
- Use of medications negatively affecting cognition (e.g., high-dose benzodiazepines, narcotics, certain anticholinergics)
- Presence of certain neurological disorders such as Huntington's disease, multiple sclerosis, Parkinson's disease, or amyotrophic lateral sclerosis
- Acute, severe unstable medical illness or active cancer with metastases
- Contraindications to MRI scanning or inability to complete baseline MRI
- Regular use of crosswords or computerized cognitive training averaging once or more per week in the past year
- Participation in another cognitive enhancing drug or device clinical trial
- Geriatric Depression Scale score of 6 or higher (short form)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants complete 12 weeks of cognitive training with crossword puzzles or health education. Those in the high dose crossword group complete four puzzles weekly, and those in the low dose group complete one puzzle weekly. The health education group reads book chapters and reviews them with study staff. Assessments occur in person at weeks 0 and 12.
2 in-person visits (weeks 0 and 12) plus home-based sessions weekly
Follow-up
Duration - Approximately 66 weeks
Participants complete booster sessions consisting of crossword puzzles or health education activities at weeks 20, 32, 42, 52, 64, and 78. In-person assessments occur at weeks 32, 52, and 78 with additional home or phone sessions depending on group assignment.
5 in-person visits and multiple home-based or phone sessions over booster weeks
Trial Site Locations
Total: 4 locations
1
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Actively Recruiting
2
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
3
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
4
University of Washington
Seattle, Washington, United States, 98104
Actively Recruiting
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Research Team
L
Lola Nedic, BA
D
Davangere P Devanand, MD, MBBS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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