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

Fujian Provincial Hospital128 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

128

Interventions

Multi-domain Cognitive InterventionBEHAVIORAL

* 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.

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Memory

The Chinese version of Auditory Verbal Learning Test will be used to assess the memory. This includes immediate memory, short-term memory, long-term memory, and recognition memory. A higher score indicates better memory performance.

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

Verbal fluency

The Chinese version of Verbal Fluency Test will be used to assess the verbal fluency. A higher score indicates better verbal language performance.

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

Naming difficulty

The Chinese version of Boston Naming Test will be used to assess the naming difficulty. The total scores range from 0 to 30, a higher score indicates better language functioning.

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

Executive function

The Chinese version of Shape Trail Test will be used to assess the execuite function. The shorter the usage time indicates better executive functioning.

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

Visuospatial skills

The Chinese version of Rey-Osterrieth Complex Figure Test will be used to assess the visuospatial skills. A higher score indicates better visual-spatial structural abilities.

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

Health-Promoting Lifestyle

The Chinese version of Health-Promoting Lifestyle Profile-II will be used to assess the health lifestyle . The total score range from 40 to 160. A higher score indicates better health lifestyle.