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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 1 центр

• Fujian Provincial Hospital — Фучжоу

Публикации

• 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

Идентификаторы

NCT: NCT06442943 · K2024-04-028

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗