Impact of the Digital Multi-domain Cognitive Intervention in High-risk Populations for Dementia

NCT06442943 | Recruiting DMC

• 1 other identifier: K2024-04-028
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Dementia is a chronic, progressive neurodegenerative disease characterized by acquired cognitive impairment as its core manifestation. The most common type of dementia is Alzheimer's Disease (AD), also known as "Senile Dementia," accounting for 60-80% of all dementia cases. Currently, there are approximately 10 million AD patients in China, with the number showing an increasing trend year by year, imposing a heavy economic and caregiving burden on families and society. Studies have shown that AD has a clinically silent period of 15 to 20 years (SCD\\MCI), where the risk of developing dementia is ten times higher than that of healthy elderly individuals. Nearly 50% of MCI patients progress to dementia within 5 years, and about 14.1% of SCD patients develop dementia within the same timeframe. Early detection, diagnosis, and intervention are currently the most effective strategies for preventing and treating AD. Therefore, this study aims to verify the intervention effect of integrated cognitive intervention in high-risk populations for senile dementia (SCD, MCI) based on the cognitive rehabilitation model through randomized controlled trials, and to analyze attrition rates, participation rates, etc., which have good research and application value.

Conditions

Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• Global cognitive function

  The Chinese version of Montreal Cognitive Assessment will be used to assess the global cognitive function.The scale has a total score of 30 points, encompassing eight assessment sections: visual-spatial and executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation. It involves multiple cognitive domains. A higher score indicates better cognitive functioning.

  Baseline (pre-intervention), six-month follow-up (post-intervention)

Secondary Outcomes (16)

• Memory

  Baseline (pre-intervention), six-month follow-up (post-intervention)

• Verbal fluency

  Baseline (pre-intervention), six-month follow-up (post-intervention)

• Naming difficulty

  Baseline (pre-intervention), six-month follow-up (post-intervention)

• Executive function

  Baseline (pre-intervention), six-month follow-up (post-intervention)

• Visuospatial skills

  Baseline (pre-intervention), six-month follow-up (post-intervention)

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants in the intervention group received the digtal multi-domain cognitive intervention. The digital multi-domain cognitive intervention system is used to carry out various intervention activities. The activities include learning about health knowledge once a week; home-based exercise three times per week, for 30 minutes each time; art therapy once a week, for 90 minutes at a time; and cognitive training, which includes memory, attention, executive function, and visuospatial training, conducted three times per week, with each session lasting 30 minutes.

Behavioral: Multi-domain Cognitive Intervention

Control group

OTHER

Participant in the control group reveived the health education , once a week, covering the prevention and treatment of chronic diseases in the elderly, as well as healthy lifestyles for the elderly

Behavioral: Multi-domain Cognitive Intervention

Interventions

Multi-domain Cognitive Intervention BEHAVIORAL

* Cognitive rehabilitation includes home-based exercise, three times per week, for 30 minutes each session. * Cognitive stimulation involves art therapy, once a week, for 90 minutes per session. * Cognitive training encompasses memory, attention, executive function, and visuospatial training, conducted three times per week, with each session lasting 30 minutes. * Health education, once a week, covering the prevention and treatment of chronic diseases in the elderly, as well as healthy lifestyles for the elderly.

Control group; Intervention group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• MCI (refer to Peterson's diagnostic criteria) or SCD (refer to the diagnostic framework proposed by Jak bondi and Jessen et al.);
• Able to communicate normally in Mandarin;
• Certain level of comprehension and judgment abilities, aware of the purpose of the survey and consents to participate.

You may not qualify if:

• Patients with dementia exhibiting abnormal mental behavior;
• Individuals with severe hearing or speech impairments;
• Those with serious physical illnesses who are unable to cooperate and complete the survey.

Sponsors & Collaborators

• Fujian Provincial Hospital: lead

Study Sites (1)

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Related Publications (1)

• Yan Y, Lin X, Lu Y, Fang Z, Fu X, Wu S, Wei B, Wang Z, Chen Y, Chen Z, Lin R, Li H. Effects of a Digital Multidomain Cognitive Intervention in Older People at High Risk of Dementia: A Randomized Clinical Trial. J Clin Psychiatry. 2026 Jan 7;87(1):25m15860. doi: 10.4088/JCP.25m15860.

  PMID: 41499182 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yuanjiao Yan, PhD

  Shengli clinical medical college of Fujian Medical university

  STUDY DIRECTOR

Central Study Contacts

lian fayang, MD

CONTACT

0591-87557768; fjslkyk@163.com

Yuanjiao Yan, PhD

CONTACT

18120826271; yuanjiao1994@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 5, 2024
• Study Start: June 4, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: After completion of the study, relevant data will be provided in the form of a universal resource locator or digital object identifier.
• Access Criteria: Researchers whose proposed use of the data has been approved

Locations

CN (1)