Clinical trial NCT05007353: The SINgapore GERiatric Intervention Study to Reduce Cognitive Decline and Physical Frailty (SINGER) Study
Official title: The SINgapore GERiatric Intervention Study to Reduce Cognitive Decline and Physical Frailty (SINGER) Study, Biomarker and Health Service Research Analyses
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Impairment
Alzheimer Disease
Vascular Cognitive Impairment
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorder
Keywords: cognitive decline
cognitive impairment
multi-domain lifestyle interventions
dementia
elderly
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: National Medical Research Council (NMRC), Singapore
First posted: 2021-08-16
Enrollment: 1200
Sex: ALL
Minimum age (years): 60
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A study in Finland found that a multidomain intervention of physical activity, nutritional guidance, cognitive training, social activities and management of vascular risk factors slowed cognitive decline in healthy older adults at increased risk of cognitive decline. A 6-month pilot study was initiated in Singapore, which demonstrated the cultural feasibility and practicality of the FINGER interventions and a set of locally adapted interventions in an Asian population. The SINGER study is a 2-year randomized controlled trial that aims to test the efficacy and safety of these lifestyle changes, including diet and cardiovascular risk factor management, cognitive and physical exercises, in delaying cognitive decline in older adults at risk of dementia.

Detailed description: Results from a population-based 2-year clinical trial, the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER), demonstrated that a multidomain intervention of physical activity, nutritional guidance, cognitive training, social activities and management of vascular risk factors slowed cognitive decline in healthy older adults at increased risk of cognitive decline. Currently, no pharmacological treatment options that can rival these effects. Thus, there is an urgent need to test the generalizability, adaptability, and sustainability of these findings in Singaporean populations. A 6-month pilot study was initiated in Singapore, which demonstrated the cultural feasibility and practicality of the FINGER interventions and a set of locally adapted interventions in an Asian population. Hence, the next step was to conduct a larger scale SINGER trial to determine the efficacy of these interventions in Singapore. If the interventions are found to be effective and safe with high applicability and scalability, the study will provide important clinical and public health implications to a rapidly increasing ageing population.

Eligibility criteria: Inclusion Criteria:

* Age 60-77 years
* Able to understand English/Chinese
* Risk of dementia: Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) dementia risk score \>6 indicating the presence of modifiable risk factors Modifiable lifestyle factors (fulfilling at least one of the following LIBRA index for diet, cognitive activity, physical activity)
* Cognitive performance at the mean level or slightly lower than expected for age (MoCA ≥18, ≤27)
* No plans to travel outside of Singapore for an extended period of time over the course of the study
* 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:

* malignant diseases
* dementia
* substantial cognitive decline (MoCA\<18)
* major depression
* symptomatic cardiovascular disease
* revascularisation within 1 year
* severe loss of vision, hearing or communicative ability
* other conditions inhibiting from safe engagement in the prescribed intervention and other conditions preventing cooperation, as judged by the study physician

Primary outcomes:
measure: Global Cognition
timeFrame: Up to 2 years
Secondary outcomes:
measure: Episodic Memory
timeFrame: Up to 2 years
measure: Executive Function
timeFrame: Up to 2 years
measure: Processing Speed
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: The Geriatric Depression Scale (GDS)
timeFrame: Up to 2 years
measure: Global Physical Activity Questionnaire (GPAQ)
timeFrame: Up to 2 years
measure: Prospective-Retrospective Memory Questionnaire
timeFrame: Up to 2 years
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Up to 2 years
measure: Leisure-Time Activities Questionnaire
timeFrame: Up to 2 years
measure: Physical Performance Test (PPT)
timeFrame: Up to 2 years
measure: Quality of Life Questionnaire (15D)
timeFrame: Up to 2 years
measure: 36-Item Short Form Survey (SF-36)
timeFrame: Up to 2 years
measure: Resource Use Inventory (RUI)
timeFrame: Up to 2 years
measure: Height
timeFrame: Up to 2 years
measure: Weight
timeFrame: Up to 2 years
measure: Hip and 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: Neuroimaging
timeFrame: Up to 2 years
measure: Blood Biomarkers
timeFrame: Up to 2 years
measure: Retinal Imaging Markers
timeFrame: Baseline only
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National University of Singapore, Yong Loo Lin School of Medicine
city: Singapore
country: Singapore
facility: National Neuroscience Institute @ Tan Tock Seng Campus (NNI @ TTSH campus)
Study officials:
affiliation: National University of Singapore
name: Christopher LH Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.
citation: Chew KA, Xu X, Siongco P, Villaraza S, Phua AKS, Wong ZX, Chung CY, Tang N, Chew E, Henry CJ, Koo E, Chen C. SINgapore GERiatric intervention study to reduce physical frailty and cognitive decline (SINGER)-pilot: A feasibility study. Alzheimers Dement (N Y). 2021 Mar 15;7(1):e12141. doi: 10.1002/trc2.12141. eCollection 2021.