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NCT05007353 | RECRUITING | Cognitive Impairment


The SINgapore GERiatric Intervention Study to Reduce Cognitive Decline and Physical Frailty (SINGER) Study
Sponsor:

National University of Singapore

Information provided by (Responsible Party):

Christopher Chen Li-Hsian

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.

Condition or disease

Cognitive Impairment

Alzheimer Disease

Vascular Cognitive Impairment

Dementia

Brain Diseases

Central Nervous System Diseases

Nervous System Diseases

Neurocognitive Disorders

Mental Disorders

Cognition Disorder

Intervention/treatment

Structured Lifestyle Intervention

Self-Guided Intervention

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 1200 participants
Masking : SINGLE
Primary Purpose : SUPPORTIVE_CARE
Official Title : The SINgapore GERiatric Intervention Study to Reduce Cognitive Decline and Physical Frailty (SINGER) Study, Biomarker and Health Service Research Analyses
Actual Study Start Date : 2021-08-23
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2026-01-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 60 Years to 77 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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

The SINgapore GERiatric Intervention Study to Reduce Cognitive Decline and Physical Frailty (SINGER) Study

Location Details

NCT05007353


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How to Participate

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Locations


RECRUITING

Singapore,

National University Hospital

Singapore, Singapore, 117600

RECRUITING

Singapore,

National University of Singapore, Yong Loo Lin School of Medicine

Singapore, Singapore, 117600

NOT YET RECRUITING

Singapore,

National Neuroscience Institute @ Tan Tock Seng Campus (NNI @ TTSH campus)

Singapore, Singapore, 308433

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