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

Overview

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.

Detailed description

Based on the cognitive rehabilitation model, this study aims to develop a digital multimodal cognitive intervention program, and conduct feasibility studies and randomized controlled trials. The intervention includes health knowledge education, exercise intervention, art intervention, and cognitive training, etc. The feasibility, effectiveness, and safety of this intervention approach will be evaluated.

Interventions

• Behavioral Multi-domain Cognitive Intervention
  * 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 hea

Primary outcome measures

• Global cognitive function [Time frame: Baseline (pre-intervention), six-month follow-up (post-intervention)]

Secondary outcome measures (12)

• Memory [Time frame: Baseline (pre-intervention), six-month follow-up (post-intervention)]
• Verbal fluency [Time frame: Baseline (pre-intervention), six-month follow-up (post-intervention)]
• Naming difficulty [Time frame: Baseline (pre-intervention), six-month follow-up (post-intervention)]
• Executive function [Time frame: Baseline (pre-intervention), six-month follow-up (post-intervention)]
• Visuospatial skills [Time frame: Baseline (pre-intervention), six-month follow-up (post-intervention)]
• Health-Promoting Lifestyle [Time frame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)]
• Abilities for health practices [Time frame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)]
• Lonliness [Time frame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)]
• Social network [Time frame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)]
• Quality of life of Alzheimer's disease [Time frame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)]
• Anxiety [Time frame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)]
• Depression [Time frame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

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

Double blind

Primary purpose

Supportive care

Study locations

China · 1 center

• Fujian Provincial Hospital — Fuzhou

Publications

• 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

Identifiers

NCT: NCT06442943 · K2024-04-028

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗