Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability

Not Applicable

Active, not recruiting

• Conditions: Dementia; Cognitive Impairment
• Interventions: Behavioral: Nutritional guidance; Behavioral: Exercise; Behavioral: Cognitive training; Other: Reduction of vascular risk factors

• Registration Number: NCT01041989
• Lead Sponsor: Finnish Institute for Health and Welfare

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-01-04
• Study First Submitted QC: 2010-01-04
• Study First Posted: 2010-01-05
• Primary Completion: 2013-12
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-17
• Last Update Posted: 2023-04-19
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle counseling	Exercise	Multi-domain lifestyle counseling including nutritional guidance, increased physical activity, cognitive training, increased social activity and intensive monitoring of vascular and metabolic risk factors.
Lifestyle counseling	Reduction of vascular risk factors	Multi-domain lifestyle counseling including nutritional guidance, increased physical activity, cognitive training, increased social activity and intensive monitoring of vascular and metabolic risk factors.
Lifestyle counseling	Cognitive training	Multi-domain lifestyle counseling including nutritional guidance, increased physical activity, cognitive training, increased social activity and intensive monitoring of vascular and metabolic risk factors.
Lifestyle counseling	Nutritional guidance	Multi-domain lifestyle counseling including nutritional guidance, increased physical activity, cognitive training, increased social activity and intensive monitoring of vascular and metabolic risk factors.

Primary Outcome Measures

Name	Time	Method
Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests.	2 years

Secondary Outcome Measures

Name	Time	Method
Disability will be assessed using the ADCS-ADL scale	2 years
Vascular and metabolic risk factors will be assessed with blood pressure and anthropometric measurements, and laboratory analyses of metabolic biomarkers.	2 years
Depressive symptoms will be assessed using the Zung depression scale.	2 years
Quality of Life will be assessed using the RAND-36 and 15D questionnaires.	2 years
Vascular and metabolic morbidity and mortality will be assessed through questionnaire and register data.	2 years
Changes in dietary biomarker levels will be assessed through laboratory testing.	2 years
Utilization of health resources will be assessed using questionnaire and register data.	2 years

Trial Locations

Locations (4)

Finnish Institute for Health and Welfare; 🇫🇮 Turku, Finland

University of Oulu; 🇫🇮 Oulu, Finland

University of Eastern Finland; 🇫🇮 Kuopio, Finland

Research Center Mediwest; 🇫🇮 Seinajoki, Finland