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

ConditionsMild Cognitive Impairment (MCI)Cognitive Training

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age55-89

SponsorColumbia University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Diagnosis of dementia of any type.

Current clinical diagnosis of schizophrenia, schizoaffective disorder, psychosis, or bipolar I disorder (Diagnostic and Statistical Manual of Mental Disorders (DSM-5 TR) criteria).

Current unstable or untreated major depression, or active suicidality based on a Suicide Severity Rating Scale (C-SSRS Screen version: positive answer to question 1 or 2 followed by item 6 positive answer leads to exclusion. Negative answer to questions 1 and 2: interview ends and the participant is not excluded for active suicidality).

Current or recent (past 6 months) alcohol or substance use disorder (DSM-5 TR criteria).

Trial design

Design model

Parallel

Treatments tested in this trial

Cognitive Training
Other intervention
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.

Treatment groups

240 Participants

are divided into 3 treatment groups

Group A: ControlPlacebo comparator 1 intervention

Group B: Low Dose CrosswordActive comparator 1 intervention

Group C: High Dose CrosswordActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

The ADASCog-14 is a brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia. It is one of the most widely used cognitive scales in clinical trials and is considered to be the "gold standard" for assessing antidementia treatments. The total score range is 0 to 90; a higher score indicates greater cognitive impairment.

Time frame

Baseline, 78 weeks

Secondary outcomes

Change in Functional Activities Questionnaire (FAQ) score

The FAQ is a patient-reported measure of cognitive impairment on difficulties in activities of daily living. The total score range is 0 to 30, with a higher score indicating greater impairment.

Time frame

Baseline, 78 weeks

Change in MRI hippocampal volume

The hippocampal volume is a measurement of brain atrophy. Hippocampal volume ranges from 0 to 10 cu cm with higher values indicating large hippocampal volume. Decrease in this measure indicates hippocampal atrophy.

Time frame

Baseline, 78 weeks

Change in cortical thickness

The cortical thickness is a measurement of brain atrophy. Values range from 0 to 1 with higher values indicating greater cortical thickness.

Time frame

Baseline, 78 weeks

Other outcomes

Change in Preclinical Alzheimer Composite-5 (PACC5)

PACC5 provides a comprehensive assessment of Alzheimer's disease-relevant cognitive impairment and to serve as a tool with validated sensitivity to detect cognitive decline over time. It is comprised of five tests: Mini-Mental State Examination (total score range 0-30), Wechsler Memory Scale-Revised Logical Memory Delayed Recall (total score range 0-25), Digit-Symbol Coding Test (total score range 0-93), Free and Cued Selective Reminding Test Free + Total Recall (total score range 0-96), and Category Fluency Test (graded by number of correct words belonging in the categories of animals, fruits, and vegetables; not graded on a scale). The PACC5 is computed as an averaged z-score of all five tests.

Time frame

Baseline, 78 weeks

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

The range of scores of the 15 items ADL question is 0-45 with higher scores indicating better performance. This is the outcome measure. In addition, there is a range of scores for the 5 items of physical function questions, which is 0-5 with higher scores indicating intact physical functioning.

Time frame

Baseline, 78 weeks

plasma neurofilament light and ptau 217

Evaluate change in biomarkers over 78 weeks in the two crosswords groups and health education control group. Range = 0-999 ng/ml with higher values indicating more brain pathology.

Time frame

Baseline, 78 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Columbia University

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov

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