Clinical trial NCT06524388: Adaptive Cognitive Training on Cognitive Function in Elderly Diabetes Patients in the Community
Official title: The Effects of COgNitive Training in Community-dwelling Older Adults at High Risk for demENTia and With Diabetes (CONTENT-Diabetes): a Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cognition
Diabetes Mellitus, Type 2
Aging
Lead sponsor: Peking Union Medical College
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objective A growing body of evidence supports diabetes as a risk factor for cognitive decline. Diabetes is significantly associated with accelerated cognitive decline, poorer cognitive function, and mild cognitive impairment and dementia. Cognitive training is an effective intervention to improve cognitive function. However, the current cognitive training does not fully consider the different areas and degrees of cognitive function impairment of older adults. This study aims to evaluate the effect of adaptive cognitive training on cognitive function of older adults with hypertension in the community.

Participants Age 60 years or older, diagnosis of diabetes, fasting blood glucose≥6.1mmol/L and cognitive function assessment showed no dementia.

Design The study was designed as a double-blind randomized controlled trial. 120 diabetes participants without dementia aged 60 years or older in Shijingshan, Beijing were included. Participants will be randomized to adaptive cognitive training (intervention group) and placebo cognitive training (control group) at a ratio of 1:1. Both training will be delivered by using PADs with the same appearance. The interventions will last for 6 months and follow up to 12 months, and both groups will be followed up on the same time schedules for all outcome measurements. The primary outcome is changes in MoCA scores from baseline to post-intervention, 6 months. The current trial has been reviewed by the Ethics Committee of Plastic Surgery Hospital, Chinese Academy of Medical Sciences \& Peking Union Medical College (approval number: 2024-162).


Eligibility criteria: Inclusion Criteria:

* with a clear diagnosis of diabetes (according to ICD-10 or DSM-criteria), fasting blood glucose≥6.1mmol/L, maintaining the original diabetes treatment strategy
* age ≥60 years old
* literate and able to use smart phone or tablet computer skillfully, with CAIDE dementia risk score \>9, but without a diagnosis of dementia (ICD-10 or DSM-dementia diagnostic criteria)
* have lived in the target community for at least 6 months and continue to live in the original community for the next 12 months

Exclusion Criteria:

* Stroke or brain surgery in the previous 12 months
* Alcohol or drug abuse in the past 12 months
* Families, important people of participants in the study have concerns
* Live in the same household as a participant who has been randomly assigned
* Severe aphasia, physical disability, or any other factor that may prevent completion of neuropsychological testing
* Use of medications that may affect cognition, including sedatives, anxiolytics, hypnotics, nootropics, and cholinergic drugs; Refusing or not receiving cognitive training
* currently participating in another clinical trial.

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: baseline; post-intervention, 6 months
Secondary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: baseline; post-intervention, 3 months; 12-month follow up
measure: the Trail Making Test (TMT)
timeFrame: baseline; post-intervention, 3 months; post-intervention, 6 months; 12-month follow up
measure: the Digit Symbol Substitution Test (DSST)
timeFrame: baseline; post-intervention, 3 months; post-intervention, 6 months; 12-month follow up
measure: the WHO-UCLA Auditory Verbal Learning Test(AVLT)
timeFrame: baseline; post-intervention, 3 months; post-intervention, 6 months; 12-month follow up
measure: the Boston Naming Test (BNT)
timeFrame: baseline; post-intervention, 3 months; post-intervention, 6 months; 12-month follow up
measure: Geriatric Depression Scale (GDS)
timeFrame: baseline; post-intervention, 3 months; post-intervention, 6 months
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: baseline; post-intervention, 3 months; post-intervention, 6 months
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: baseline; post-intervention, 3 months; post-intervention, 6 months
measure: fasting blood glucose
timeFrame: baseline; post-intervention, 3 months; post-intervention, 6 months; 12-month follow up
Other outcomes:
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