Clinical trial NCT01041989: Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability
Official title: Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cognitive Impairment
Dementia
Keywords: dementia
cognitive impairment
disability
intervention
elderly
lifestyle counseling
Lead sponsor: Finnish Institute for Health and Welfare
Sponsor class: OTHER_GOV
Collaborators: name: Academy of Finland
name: University of Helsinki
name: University of Eastern Finland
name: University of Oulu
name: Kuopio Research Institute of Exercise Medicine
name: Western University, Canada
name: Karolinska Institutet
name: Umeå University
First posted: 2010-01-05
Enrollment: 1200
Sex: ALL
Minimum age (years): 60
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: 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

Primary outcomes:
measure: Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests.
timeFrame: 2 years
Secondary outcomes:
measure: Depressive symptoms will be assessed using the Zung depression scale.
timeFrame: 2 years
measure: Disability will be assessed using the ADCS-ADL scale
timeFrame: 2 years
measure: Quality of Life will be assessed using the RAND-36 and 15D questionnaires.
timeFrame: 2 years
measure: Utilization of health resources will be assessed using questionnaire and register data.
timeFrame: 2 years
measure: Vascular and metabolic risk factors will be assessed with blood pressure and anthropometric measurements, and laboratory analyses of metabolic biomarkers.
timeFrame: 2 years
measure: Vascular and metabolic morbidity and mortality will be assessed through questionnaire and register data.
timeFrame: 2 years
measure: Changes in dietary biomarker levels will be assessed through laboratory testing.
timeFrame: 2 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Finnish Institute for Health and Welfare
city: Kuopio
country: Finland
facility: University of Eastern Finland
city: Oulu
country: Finland
facility: University of Oulu
city: Seinajoki
country: Finland
facility: Research Center Mediwest
city: Turku
country: Finland
facility: Finnish Institute for Health and Welfare
Study officials:
affiliation: Finnish Institute for Health and Welfare
name: Miia Kivipelto, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Finnish Institute for Health and Welfare
name: Tiina K Laatikainen, professor
role: STUDY_DIRECTOR
affiliation: University of Eastern Finland
name: Hilkka S Soininen, professor
role: STUDY_DIRECTOR
affiliation: University of Helsinki
name: Jaakko Tuomilehto, professor
role: STUDY_DIRECTOR
affiliation: University of Oulu
name: Timo E Strandberg, professor
role: STUDY_DIRECTOR
affiliation: University of Eastern Finland
name: Raimo Sulkava, professor
role: STUDY_DIRECTOR
affiliation: Kuopio Research Institute of Exercise Medicine
name: Rainer Rauramaa, professor
role: STUDY_DIRECTOR
affiliation: Finnish Institute for Health and Welfare
name: Antti Jula, research prof
role: STUDY_DIRECTOR
affiliation: Finnish Institute for Health and Welfare
name: Markku Peltonen, research professor
role: STUDY_DIRECTOR
affiliation: Finnish Institute for Health and Welfare
name: Satu Havulinna, PhD
role: STUDY_DIRECTOR
affiliation: Finnish Institute for Health and Welfare
name: Jaana Lindström, Adjunct prof.
role: STUDY_DIRECTOR
affiliation: Oulu City Health Services
name: Riitta Antikainen, professor
role: STUDY_DIRECTOR
affiliation: Finnish Institute for Health and Welfare
name: Tiia Ngandu, MD, PhD, Adjunct professor
role: STUDY_DIRECTOR
affiliation: University of Eastern Finland
name: Tuomo Hänninen, Adjunct prof
role: STUDY_DIRECTOR
affiliation: Finnish Institute for Health and Welfare
name: Jenni Lehtisalo, PhD
role: STUDY_DIRECTOR
affiliation: University of Eastern Finland
name: Alina Solomon, MD, PhD, Adjunct professor
role: STUDY_DIRECTOR
References:
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