Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER)

Finnish Institute for Health and Welfare

Status: Active, not recruiting

Conditions: Cognitive Impairment; Dementia

Treatments: Behavioral: Cognitive training; Behavioral: Exercise; Behavioral: Nutritional guidance; Other: Reduction of vascular risk factors

Study type: Interventional

Funder types: Other

Identifiers

NCT01041989

THL/TUET 122/2009

Details and patient eligibility

About

This multi-center (6 sites: Helsinki, Kuopio, Oulu, Seinäjoki, Turku, Vantaa) intervention study aims to prevent cognitive impairment, dementia and disability in 60-77 year old persons at an increased dementia risk. The 2-year multi-domain life-style intervention includes nutritional guidance, exercise, cognitive training, increased social activity, and intensive monitoring and management of metabolic and vascular risk factors. The primary outcome is cognitive impairment measured by a sensitive Neuropsychological Test Battery (NTB), and Stroop and Trail Making tests to capture early cognitive impairment typical for both Alzheimer's disease and vascular dementia. We hypothesize that the multi-domain intervention will reduce cognitive impairment in the study group compared to the control group during the initial 2-year intervention period and reduce dementia incidence after the extended follow-up (until at least 300 participants have developed dementia).

Enrollment: 1,200 estimated patients

Sex: All

Ages: 60 to 77 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged 60-77 years
• dementia Risk Score 6 points or more
• fulfillment of at least one of the following CERAD criteria: i) MMSE: 20-26 points ii) word list memory task (3x10 words): 19 words or less iii) delayed recall: 75% or less

Exclusion criteria

• malignant diseases
• dementia
• substantial cognitive decline
• 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 as judged by the study physician
• other conditions preventing from cooperation as judged by the study physician

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,200 participants in 2 patient groups

Standard health counseling at baseline

No Intervention group

Lifestyle counseling

Experimental group

Description:

Multi-domain lifestyle counseling including nutritional guidance, increased physical activity, cognitive training, increased social activity and intensive monitoring of vascular and metabolic risk factors.

Treatment:

Behavioral: Nutritional guidance

Behavioral: Exercise

Other: Reduction of vascular risk factors

Behavioral: Cognitive training