Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability

Not Applicable

Active, not recruiting

• Conditions: Dementia; Cognitive Impairment

• 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

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
Utilization of health resources will be assessed using questionnaire and register data.	2 years
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

Trial Locations

Locations (4)

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

University of Eastern Finland; 🇫🇮 Kuopio, Finland

University of Oulu; 🇫🇮 Oulu, Finland

Research Center Mediwest; 🇫🇮 Seinajoki, Finland