Cognitive Impairment, Dementia
Conditions
Keywords
dementia, cognitive impairment, disability, intervention, elderly, lifestyle counseling
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).
Interventions
BEHAVIORALNutritional guidance
Individual counseling sessions and group meetings will be organized.
BEHAVIORALExercise
Guided muscle strength training and aerobic exercise.
BEHAVIORALCognitive 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.
OTHERReduction of vascular risk factors
Monitoring and maintenance of metabolic and vascular risk factors
Sponsors
University of Eastern Finland
Academy of Finland
University of Helsinki
University of Oulu
Kuopio Research Institute of Exercise Medicine
Karolinska Institutet
Umeå University
Finnish Institute for Health and Welfare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 77 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests. | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Depressive symptoms will be assessed using the Zung depression scale. | 2 years |
| Disability will be assessed using the ADCS-ADL scale | 2 years |
| Quality of Life will be assessed using the RAND-36 and 15D questionnaires. | 2 years |
| Utilization of health resources will be assessed using questionnaire and register data. | 2 years |
| Vascular and metabolic risk factors will be assessed with blood pressure and anthropometric measurements, and laboratory analyses of metabolic biomarkers. | 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 |
Countries
Finland
Contacts
PRINCIPAL_INVESTIGATORMiia Kivipelto, Professor
University of Eastern Finland
STUDY_DIRECTORTiina Laatikainen, Professor
University of Eastern Finland
STUDY_DIRECTORHilkka Soininen, Professor
University of Eastern Finland
STUDY_DIRECTORJaakko Tuomilehto, Professor
University of Helsinki
STUDY_DIRECTORTimo Strandberg, Professor
University of Oulu
STUDY_DIRECTORMarkku Peltonen, Research professor
Finnish Institute for Health and Welfare
STUDY_DIRECTORJaana Lindström, Professor
Finnish Institute for Health and Welfare
STUDY_DIRECTORRiitta Antikainen, Professor
Oulu City Health Services
STUDY_DIRECTORTiia Ngandu, MD, PhD, Docent
University of Eastern Finland
STUDY_DIRECTORJenni Lehtisalo, PhD
University of Eastern Finland
STUDY_DIRECTORAri Solomon, Professor
University of Eastern Finland
Outcome results
None listed