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Enrolling by invitation NCT06512922

Adaptive Cognitive Training on Cognitive Function in Elderly Hypertension Patients in the Community

No phase Interventional Hypertension Condition Aging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: adaptive cognitive training, placebo cognitive training.
Who it may be relevant to
Registry conditions: Hypertension, Condition, Aging. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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).

Interventions

  • Device adaptive cognitive training
    The intervention was computerized, multi-domain, adaptive cognitive training. Training areas include processing speed, attention, perception, long-term memory, working memory, computation, executive control, reasoning, and problem-solving. Embedded in the Adaptive Cognitive training application is an adaptive algorithm that will help provide each participant with a cognitive training task at the right level of difficulty based on their profile and real-time performance.
  • Device placebo cognitive training
    They received cognitive training tasks of fixed difficulty.

Primary outcome measures

  • Montreal Cognitive Assessment (MoCA) [Time frame: baseline; "post-intervention, 12 weeks"]
Secondary outcome measures (9)
  • Montreal Cognitive Assessment (MoCA) [Time frame: baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up]
  • the Trail Making Test (TMT) [Time frame: baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up]
  • the Digit Symbol Substitution Test (DSST) [Time frame: baseline; 6 week-intervention; post-intervention, 12 weeks; 24 weeks follow-up]
  • the WHO-UCLA Auditory Verbal Learning Test(AVLT) [Time frame: baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up]
  • the Boston Naming Test (BNT) [Time frame: baseline; 6 week-intervetion; "post-intervention, 12 weeks"; 24 weeks follow-up]
  • Geriatric Depression Scale (GDS) [Time frame: baseline; 6 week-intervention; "post-intervention, 12 weeks"]
  • Generalized Anxiety Disorder-7 (GAD-7) [Time frame: baseline; 6 week-intervention; "post-intervention, 12 weeks"]
  • Pittsburgh sleep quality index (PSQI) [Time frame: baseline; 6 week-intervention; "post-intervention, 12 weeks"]
  • Blood pressure [Time frame: baseline; "post-intervention, 12 weeks"]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

China · 1 center
  • Xihuangcun Hospital — Beijing

Publications

  • Pan Y, Ji M, Liang J, Ma J, Zhang W, Liu Y, Dai Y, Gao D, Zhang Y, Xie W, Zheng F. Effects of COgNitive Training in Community-dwelling Older Adults at High Risk for demENTia (CONTENT): study protocol of two double-blind, randomised, placebo-controlled trials. BMJ Open. 2026 Feb 9;16(2):e095515. doi: 10.1136/bmjopen-2024-095515. PMID 41663164

Identifiers

NCT: NCT06512922 · CMB22-466

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗