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

National University of Singapore

Status: Enrolling

Conditions: Alzheimer Disease; Mental Disorders; Vascular Cognitive Impairment; Cognitive Impairment; Cognition Disorder; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia; Brain Diseases

Treatments: Behavioral: Self-Guided Intervention; Behavioral: Structured Lifestyle Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05007353

SINGER 2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 60 to 77 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,200 participants in 2 patient groups

Structured Lifestyle Intervention

Experimental group

Description:

Structured lifestyle modification program developed for participants targeting diet, physical exercise, cognitive training, and social stimulation.

Treatment:

Behavioral: Structured Lifestyle Intervention

Self-Guided Intervention

Experimental group

Description:

General health information provided to participants.

Treatment:

Behavioral: Self-Guided Intervention