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Behavioural Intervention

Cognitive Training for Mild Cognitive Impairment (COGIT-2 Trial)

N/A

Recruiting

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants need to be 55 to 89 years of age at the time of informed consent

Be older than 18 years old

Must not have

Presence of specific disorders like CNS infections, Huntington's disease, etc.

Current clinical diagnosis of schizophrenia, schizoaffective disorder, psychosis, or bipolar I disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 78 weeks

Summary

"This trial will study how crossword puzzles can help people with mild cognitive impairment. Previous research showed that crossword puzzles were better than computerized training at improving brain function and reducing brain shrinkage. This study will

Who is the study for?

This trial is for people aged 55-89 with mild cognitive impairment (MCI), who have an informant to report on their functioning, access to a computer or tablet with internet, and can read English at a 6th-grade level. Women must be post-menopausal. Participants need documented memory impairment but still score above a certain threshold on a cognitive assessment.

What is being tested?

The COGIT-2 Trial is testing the effects of high dose crossword puzzles (4 per week) versus low dose crosswords (1 per week) and health education on cognition in MCI patients. It aims to see if more frequent puzzle-solving helps maintain or improve brain function compared to less frequent solving or just learning about health.

What are the potential side effects?

Since this trial involves non-medical interventions like crossword puzzles and educational materials, there are no direct medical side effects expected from participation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 55 and 89 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have CNS infections, Huntington's disease, or similar conditions.

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I have been diagnosed with schizophrenia, schizoaffective disorder, psychosis, or bipolar I disorder.

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I have been diagnosed with dementia.

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I do not have untreated major depression or thoughts of harming myself.

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I have had a stroke and still experience its effects.

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I am not currently in a clinical trial for a cognitive enhancing drug or device.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 78 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 78 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 78 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in ADASCog-14 (14-item Alzheimer's Disease Assessment Scale - Cognitive subscale)

Secondary study objectives

Change in Functional Activities Questionnaire (FAQ) score

Change in MRI hippocampal volume

Change in cortical thickness

Other study objectives

Change in Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale (ADCS-ADL-PI)

Change in Preclinical Alzheimer Composite-5 (PACC5)

plasma neurofilament light and ptau 217

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Low Dose CrosswordActive Control1 Intervention

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.

Group II: High Dose CrosswordActive Control1 Intervention

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.

Group III: ControlPlacebo Group1 Intervention

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.

0 / 7Eligibility criteria met