Adaptive Cognitive Training on Cognitive Function in Elderly Diabetes Patients in the Community
NCT Number: NCT06524388
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cognition|Diabetes Mellitus, Type 2|Aging
Interventions: DEVICE: adaptive cognitive training|DEVICE: placebo cognitive training
Sponsor: Fanfan Zheng
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2027-06

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).

Primary Outcome Measures: Montreal Cognitive Assessment (MoCA), MoCA has been widely used in the cognitive function assessment of middle-aged and elderly people in China, including executive function, memory, orientation, computation, conceptual thinking, visual perception, language, and attention. The MoCA scale scores ranged from 0 to 30, and the lower the score, the worse the cognitive function., baseline; post-intervention, 6 months
Secondary Outcome Measures: Montreal Cognitive Assessment (MoCA), MoCA has been widely used in the cognitive function assessment of middle-aged and elderly people in China, including executive function, memory, orientation, computation, conceptual thinking, visual perception, language, and attention. The MoCA scale scores ranged from 0 to 30, and the lower the score, the worse the cognitive function., baseline; post-intervention, 3 months; 12-month follow up|the Trail Making Test (TMT), The TMT assesses cognitive processing speed and executive function. The TMT consists of two parts, A and B, and is one of the most widely used neuropsychological assessment tools. The TMT-A requires the subject to connect disorderly arranged numbers from 1 to 25 in order. Investigator used a modified version that included numbers in both square and circle figures and required participants to alternate the two figures when connecting the numbers in order. The score index was the time spent on TMT-A and TMT-B and the amount of interference (time spent on TMT-B - time spent on TMT-A)., baseline; post-intervention, 3 months; post-intervention, 6 months; 12-month follow up|the Digit Symbol Substitution Test (DSST), DSST has 1-9 numbers and corresponding symbols. Subjects were required to correctly fill in the symbols under the numbers according to the corresponding relationship between numbers and symbols in the 90s content. One point was calculated for every one completed within 90 seconds, and the higher the score, the better the cognitive function., baseline; post-intervention, 3 months; post-intervention, 6 months; 12-month follow up|the WHO-UCLA Auditory Verbal Learning Test(AVLT), AVLT consisted of 15 words, which were read aloud at a rate of one word in 2 seconds while the subject listened. After reading aloud, the subjects were asked to recall the words as much as possible for 90 seconds, and the recall did not have to be in the order of reading aloud. During the recall process, the examiner recorded the correct words and their number, inserted and repeated words. The above reading and immediate recall were repeated 5 times. The total score of AVLT recall from 1 to 5 passes was the total score of immediate recall. Delayed recall and cued recall were also performed, and distractor exclusion recall was performed., baseline; post-intervention, 3 months; post-intervention, 6 months; 12-month follow up|the Boston Naming Test (BNT), There were 30 pictures in the BNT, and subjects were required to name the pictures, each of which was scored on a scale of 0-2. Two points were given for complete correctness, one point for semantic errors, and zero points for other situations. The sum of the scores of all objects gives a total score, with a maximum score of 60., baseline; post-intervention, 3 months; post-intervention, 6 months; 12-month follow up|Geriatric Depression Scale (GDS), GDS describes the participant's depressive symptoms in the past week on a scale of 0 to 15, with higher scores indicating more severe depressive symptoms., baseline; post-intervention, 3 months; post-intervention, 6 months|Generalized Anxiety Disorder-7 (GAD-7), GAD-7 assesses the anxiety of the participants in the past two weeks, with a total of 7 items. The total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms., baseline; post-intervention, 3 months; post-intervention, 6 months|Pittsburgh sleep quality index (PSQI), PSQI assesses the subjective sleep quality of participants in the past month. The total score ranges from 0 to 21, with higher scores indicating worse sleep quality., baseline; post-intervention, 3 months; post-intervention, 6 months|fasting blood glucose, Fasting blood glucose will be obtained by blood samples,which will be collected by nurses from community hospitals in a fasted state (at least 8 hours without food or water)., baseline; post-intervention, 3 months; post-intervention, 6 months; 12-month follow up