Clinical trial NCT05886114: A Multi-domain Lifestyle Intervention Among Aged Community-residents in Zhejiang, China
Official title: A Multi-domain Lifestyle Intervention Among Aged Community-residents in Zhejiang, China
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Impairment
Alzheimer Disease
Vascular Cognitive Impairment
Dement
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorder
Cognition Disorder
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 1200
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A study conducted in Finland discovered that a multidomain intervention, consisting of physical activity, nutritional guidance, cognitive training, social activities, and management of vascular risk factors, effectively decelerated cognitive decline in healthy older adults who were at an increased risk of cognitive decline. The HERITAGE study is a 2-year clustered randomized controlled trial (clustered-RCT) that explores the efficacy of a multidomain intervention among 1200 elderly residents with a higher risk of cognitive decline and dementia in Zhejiang Province, China

Detailed description: The effectiveness of a multidomain lifestyle intervention on the prevention of cognitive decline and dementia have not been studied in Asian elderly at high risk of dementia conversion. Dementia is caused by both nonmodifiable genetic variables, and modifiable lifestyle risk factors. While neuroimaging biomarkers have been well documented in the neurophysiology of ageing and age-associated cognitive decline, their role as surrogate endpoints and intermediate variables between multi-domain lifestyle intervention and cognitive benefits has not been studied. The current study aims to understand brain functional and structural changes that may result from a multi-domain lifestyle intervention and whether the changes correlate with improvement in cognitive function. At risk elderly aged 60-80 years will be randomly allocated to either the control arm (self-guided management) or the intervention (multi-domain lifestyle) arm, which consists of nutritional guidance, physical exercise, cognitive training and the monitoring and management of vascular and metabolic risk factors. We hypothesize that the multi-domain lifestyle intervention will promote favorable changes in cognitive function. Moreover, such intervention will slow down the progression of cerebrovascular disease and neurodegeneration in participants in the intervention arm. Findings from the present study will shed light on the biological mechanisms of age-related cognitive decline and neurodegenerative disease. Insight obtained from the study could be translated into new targets of nonpharmacological interventions which aim at the potential causal molecular pathways implicated in ageing and age-related cognitive decline. Adaption and implementation of our findings into clinical and public health practice will further promote healthy and confident ageing among Chinese elderly, to eventually expand their health span.

Eligibility criteria: Inclusion Criteria:

* At risk of cognitive decline: cognitive performance at the mean level or slightly lower than expected for age with no dementia (AD8\>=3 and/or 5-min MoCA \>, \< 11)
* Free of physical disabilities that preclude participation in the study
* Willing to complete all study-related activities for 24 months
* Willing to be randomized to either lifestyle intervention group

Exclusion Criteria:

* Diagnosed dementia patients
* Diagnosed major depression or other neuropsychological diseases
* Malignant diseases
* Symptomatic cardiovascular disease
* Revascularization within one year
* Severe loss of vision, hearing or communicative ability

Primary outcomes:
measure: Global Cognition
timeFrame: Up to 2 years
measure: Domain-specific Cognition
timeFrame: Up to 2 years
Secondary outcomes:
measure: Neuroimaging: MRA
timeFrame: Up to 2 years
measure: Neuroimaging: MRI
timeFrame: Up to 2 years
measure: Neuroimaging: fMRI
timeFrame: Up to 2 years
measure: Number of participants with Laboratory Values /Blood markers
timeFrame: Up to 2 years
measure: Incident dementia
timeFrame: Up to 2 years
measure: Clinical Dementia Rating-Sum of Boxes (CDR-SB)
timeFrame: Up to 2 years
measure: Alzheimer's Disease Cooperative Study Activities of Daily Living Mild Cognitive Impairment-Activities of Daily Living Inventory (ADCS MCI-ADL)
timeFrame: Up to 2 years
measure: Cardiovascular morbidity
timeFrame: Up to 2 years
measure: Physical Performance: Grip strength
timeFrame: Up to 2 years
measure: Physical Performance: Gaid speed
timeFrame: Up to 2 years
measure: Physical Performance: Balance
timeFrame: Up to 2 years
measure: Physical Performance: Endurance
timeFrame: Up to 2 years
measure: Physical Performance: Lower limb strength
timeFrame: Up to 2 years
measure: Quality of Life Questionnaire (15D)
timeFrame: Up to 2 years
measure: The Geriatric Depression Scale (GDS)
timeFrame: Up tp 2 years
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Up to 2 years
measure: Leisure-Time Activities Questionnaire
timeFrame: Up to 2 years
measure: Resource Use Inventory (RUI)
timeFrame: Up to 2 years
measure: Hight
timeFrame: Up to 2 years
measure: Weight
timeFrame: Up to 2 years
measure: Hip circumference
timeFrame: Up to 2 years
measure: Waist circumference
timeFrame: Up to 2 years
measure: Changes in Blood Pressure
timeFrame: Up to 2 years
measure: Changes in lipid Profile
timeFrame: Up to 2 years
measure: Changes in Glucose Regulation
timeFrame: Up to 2 years
measure: Retinal Imaging Markers
timeFrame: Up to 2 years
measure: Falls
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: School of Public Health and The Second Affiliated Hospital of School of Medicine, Zhejiang University, Hangzhou, China
state: Zhejiang
Study officials:
References:
citation: Xu X, Chew KA, Wong ZX, Phua AKS, Chong EJY, Teo CKL, Sathe N, Chooi YC, Chia WPF, Henry CJ, Chew E, Wang M, Maier AB, Kandiah N, Chen CL. The SINgapore GERiatric Intervention Study to Reduce Cognitive Decline and Physical Frailty (SINGER): Study Design and Protocol. J Prev Alzheimers Dis. 2022;9(1):40-48. doi: 10.14283/jpad.2022.5.
citation: Zhao X, Hu R, Wen H, Xu G, Pang T, He X, Zhang Y, Zhang J, Chen C, Wu X, Xu X. A voice recognition-based digital cognitive screener for dementia detection in the community: Development and validation study. Front Psychiatry. 2022 Jul 22;13:899729. doi: 10.3389/fpsyt.2022.899729. eCollection 2022.