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

NCT06512922 | Enrolling By Invitation

• 1 other identifier: CMB22-466
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypertension; Condition; Aging

Outcome Measures

Primary Outcomes (1)

• 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, attention and attention. The MoCA scale scores ranged from 0 to 30, and the lower the score, the worse the cognitive function.

  baseline; "post-intervention, 12 weeks"

Secondary Outcomes (9)

• Montreal Cognitive Assessment (MoCA)

  baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up

• the Trail Making Test (TMT)

  baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up

• the Digit Symbol Substitution Test (DSST)

  baseline; 6 week-intervention; post-intervention, 12 weeks; 24 weeks follow-up

• the WHO-UCLA Auditory Verbal Learning Test(AVLT)

  baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up

• the Boston Naming Test (BNT)

  baseline; 6 week-intervetion; "post-intervention, 12 weeks"; 24 weeks follow-up

Study Arms (2)

adaptive cognitive training

EXPERIMENTAL

The intervention lasted for 12 weeks. Participants will receive 30 minutes of training per day, at least five days per week. In each task, once a high accuracy (e.g. \>80%) is achieved, the task is automatically upgraded to the next difficulty level.

Device: adaptive cognitive training

placebo cognitive training

ACTIVE COMPARATOR

The intervention lasted for 12 weeks. Participants will receive 30 minutes of training per day, at least five days per week. The tasks will be set to a fixed level of difficulty.

Device: placebo cognitive training

Interventions

adaptive cognitive training DEVICE

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.

adaptive cognitive training

placebo cognitive training DEVICE

They received cognitive training tasks of fixed difficulty.

placebo cognitive training

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

(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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Xihuangcun Hospital

Beijing, Shijingshan, 100144, China

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Hypertension; Disease

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher, Associate professor

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 22, 2024
• Study Start: October 29, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN (1)