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
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
Diagnosed dementia patients
Diagnosed major depression or other neuropsychological diseases
Malignant diseases
Symptomatic cardiovascular disease
Parallel
Structured Multi-domain Intervention
BehavioralStructured Multi-domain Intervention (SMI) involves providing participants with intensive structure and support by a team of trainers to increase physical exercise, adhere to a healthy diet, cognitive training, increase intellectual/social stimulation, and better manage vascular risk factors.
Self-Guided Intervention
BehavioralIn the Self-Guided Intervention (SGI), education about the importance of a healthy lifestyle as a preventive strategy and support to encourage change will be provided.
Global Cognition
Globe cognitive performance (composite z-score) measured by comprehensive Neuropsychological Test Battery (NTB)
Domain-specific Cognition
NTB domain-specific cognitive performance (composite z-score) for memory, executive function, attention, language, visuomotor speed and visuoconstruction.
Neuroimaging: MRA
Changes in brain blood flow assessed by magnetic resonance angiography(MRA)
Neuroimaging: MRI
Changes in brain structural integrity (gray matter volume loss, white matter microstructure degradation and increase of cerebrovascular markers) assessed by T1-weighted Magnetization Prepared Rapid Gradient Recalled Echo, Fluid Attenuated Inversion Recovery (FLAIR), T2-weighted, and Susceptibility Weighted Imaging sequences
Neuroimaging: fMRI
Changes in brain functional networks assessed by fMRI
Number of participants with Laboratory Values /Blood markers
Blood samples will be collected from all patients in tubes with ethylenediaminetetraacetic acid 0.1%. Changes in Novel and accessible blood markers to monitor AD- and CeVD- associated pathologies. Plasma concentrations of cardiac markers (High-sensitive cardiac troponin T (hs Troponin T), N-terminal pro b-type natriuretic peptide (NT-proBNP) and Growth/differentiation factor 15 (GDF 15)), and peripheral biomarkers of Aβ, tau and synaptic pathology, oxidative stress, endothelial/cardiovascular injury and degenerative protein modifications (DPMs) damaged proteins will be measured by laboratory testings.
Click on the lead sponsor to view all of their trials.
