Overview

This trial is active, not recruiting.

Conditions cognitive impairment, dementia
Treatments nutritional guidance, exercise, cognitive training, reduction of vascular risk factors
Sponsor National Institute for Health and Welfare, Finland
Collaborator Academy of Finland
Start date September 2009
End date December 2013
Trial size 1200 participants
Trial identifier NCT01041989, THL/TUET 122/2009

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 7-year extended follow-up.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(No Intervention)
(Experimental)
Multi-domain lifestyle counseling including nutritional guidance, increased physical activity, cognitive training, increased social activity and intensive monitoring of vascular and metabolic risk factors.
nutritional guidance
Individual counseling sessions and group meetings will be organized.
exercise
Guided muscle strength training and aerobic exercise.
cognitive training
Cognitive training will be implemented through 8 group sessions lead by a psychologist and a computer-based cognitive training program available to participants via the internet.
reduction of vascular risk factors
Monitoring and maintenance of metabolic and vascular risk factors

Primary Outcomes

Measure
Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests.
time frame: 2 years

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 60 years up to 77 years old.

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

Additional Information

Official title Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability
Principal investigator Miia Kivipelto, professor
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by National Institute for Health and Welfare, Finland.