Clinical trial NCT06512922: Adaptive Cognitive Training on Cognitive Function in Elderly Hypertension Patients in the Community
Official title: The Effects of COgNitive Training in Community-dwelling Older Adults at High Risk for demENTia and With Hypertension (CONTENT-Hypertension): a Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hypertension
Condition
Aging
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2024-07-22
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 hypertension as a risk factor for cognitive decline. Hypertension 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 impairmentof 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 aged 60 years or older, diagnosis of hypertension, and cognitive function assessment showed no dementia.

Design The study was designed as a double-blind randomized controlled trial. 120 hypertension participants without dementia aged 60 years or older in Shijingshan and Haidian, 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 12 weeks and follow up to 24 weeks, 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 the end of the 12-week intervention.

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: (1) Could not complete neuropsychological tests; (2) Suffering other disease or medication use might affect cognitive function, such as a new stroke within 6 months before baseline or use tranquilizers; (3) Unable to use PADs or unable to complete the training; (4) Unacceptable or refuse to participate in cognitive training; (5) Living in the same family with a subject who has been randomly assigned.

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: baseline; "post-intervention, 12 weeks"
Secondary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up
measure: the Trail Making Test (TMT)
timeFrame: baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up
measure: the Digit Symbol Substitution Test (DSST)
timeFrame: baseline; 6 week-intervention; post-intervention, 12 weeks; 24 weeks follow-up
measure: the WHO-UCLA Auditory Verbal Learning Test(AVLT)
timeFrame: baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up
measure: the Boston Naming Test (BNT)
timeFrame: baseline; 6 week-intervetion; "post-intervention, 12 weeks"; 24 weeks follow-up
measure: Geriatric Depression Scale (GDS)
timeFrame: baseline; 6 week-intervention; "post-intervention, 12 weeks"
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: baseline; 6 week-intervention; "post-intervention, 12 weeks"
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: baseline; 6 week-intervention; "post-intervention, 12 weeks"
measure: Blood pressure
timeFrame: baseline; "post-intervention, 12 weeks"
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xihuangcun Hospital
state: Shijingshan
Study officials:
References: