Clinical trial NCT03938727: Cardiovascular Risk Factors, Aging and Dementia
Official title: Cardiovascular Risk Factors, Aging and Dementia (III Follow-up)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Keywords: Dementia
Aging
Alzheimer's Disease
Cognition
Frailty
Epidemiology
Lifestyle
Cardiovascula Risk Factors
Lead sponsor: University of Eastern Finland
Sponsor class: OTHER
Collaborators: name: Finnish Institute for Health and Welfare
name: Kuopio University Hospital
First posted: 2019-05-06
Enrollment: 195
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Potential participants will be selected from the original cohort of people who were invited to participate in the first CAIDE follow-up. This includes 2000 people randomly selected from the previous North Karelia and FINMONICA surverys carried out between 1972 and 1987. Any member of the original CAIDE sample still alive and living in the Kuopio or Joensuu areas (Finland) will be invited.

Brief summary: The global challenges caused by dementia affect society from both the public health and economic perspective, and are exacerbated by the rapid growth of the population in the oldest age groups. Reducing the risk of developing dementia and improving the overall health status, psychosocial wellbeing, and the quality of life of the oldest old would bear individual and public health benefits, as well as social and economic advantages. Data from long-term longitudinal cohort studies can provide invaluable information about the factors that play a key role in healthy ageing and in the development of dementia. The aim of CAIDE 85+ is to better understand the factors that, from mid- to late-life, determine the development of cognitive disorders such as dementia, as well as the overall health status, psychosocial wellbeing and quality of life in the oldest old segment of the population.

CAIDE85+ is the third follow-up of the main Cardiovascular Risk Factors, Aging and Dementia (CAIDE) study conducted in the Kuopio and Joensuu areas in Eastern Finland. During midlife, participants were initially part of two population-based health surveys (North Karelia project and FINMONICA study) carried out between 1972 and 1987. In 1998, a random sample of 2000 individuals (aged 64-79) from these cohorts were invited to participate in a first re-examination as part of the CAIDE study. A second re-examination of this population was carried out between 2005 and 2008. Individuals who are still alive and living in the Kuopio and Joensuu areas will now be invited for a third re-examination. Participants' cognitive functioning and physical fitness will be assessed, and they will be asked questions about their health status, psychosocial wellbeing, and lifestyle. Blood samples will be also collected to investigate biomarkers that may be relevant for dementia-related diseases.

Detailed description: The Cardiovascular Risk Factors, Aging and Dementia (CAIDE) study was initiated in 1998 with the main scope of investigating the potential role of modifiable risk and protective factors in the development of dementia. 2000 people, who, in mid-life between 1972 and 1987, had taken part in the North Karelia, and FINMONICA survey studies, were invited to participate. These previous cohort studies focused mostly on cardiovascular disease and related risk factors and provided baseline data for the CAIDE study. Within CAIDE, two follow-ups have been carried out so far, the first in 1998 and the second between 2005 and 2008, on average 21 and more than 30 years after the baseline studies, respectively.

The CAIDE study has, so far, provided essential knowledge on several midlife risk and protective factors for dementia, including interactions between genetics and lifestyle. In addition, the CAIDE Dementia Risk Score was developed as the first tool for predicting the risk of late-life dementia in middle-aged people, based on their lifestyle and cardiovascular risk profiles.

Ten years after the second re-examination, the CAIDE participants are now well in their middle 80s' or older. Despite being the fastest growing segment of the population, this age group has been only rarely the subject of similar observational studies. By investigating the health status, quality of life, and overall psycho-physical functionality in this population the investigators aim to further examine risk and protective factors for dementia. To this aim, a life-course approach will be applied on a unique longitudinal population-based dataset spanning over 40 years, a very long period of time that is rarely achievable in observational studies. The results will also provide insights on the predictors and determinants of quality of life and psychosocial wellbeing in the oldest old.

CAIDE85+ is the third follow-up of the main CAIDE study. At baseline (midlife), data on e.g. socio-demographics, lifestyle, anthropometric measurements, blood pressure, blood markers, and medical history were recorded. In addition, the first and second late-life re-examinations included cognitive assessments (three-step protocol for the diagnosis of Mild Cognitive Impairment and dementia), APOEƐ4 genotyping, and more detailed data on psychosocial factors, and medication use. In principle, the same measurements and methods will be used in CAIDE 85+, except for modifications/adaptations required by the specifics of the 85+ study population, or recent scientific developments related to the aims of the study. New developments compared with previous re-examinations include e.g. single-step assessment of cognitive status for all participants; more detailed assessment of physical functioning, multimorbidity and frailty; inclusion of questionnaires on oral health, sleep quality, malnutrition, and health-related quality of life.

Potential participants will be identified within the original CAIDE cohort, i.e. individuals who are still alive and living in the area where the study takes place (Kuopio and Joensuu, Finland).

Eligibility criteria: Inclusion Criteria:

* Previous invitation to the first CAIDE follow up (1998)
* Being still alive and living in the Kuopio and Joensuu areas (Finland)

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Cognitive performance, CERAD
timeFrame: One assessment within 8 weeks from consent
measure: Cognitive performance, MMSE
timeFrame: One assessment within 8 weeks from consent
measure: Clinical Dementia Rating, units on a scale.
timeFrame: One assessment within 8 weeks from consent
measure: Activity of Daily Living, Katz Index.
timeFrame: One assessment within 8 weeks from consent
measure: Activity of Daily Living, Lawton-Brody Scale.
timeFrame: One assessment within 8 weeks from consent
measure: Dementia and mild cognitive impairment
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Multimorbidity
timeFrame: Through study completion, an average of 2 years
measure: Frailty Index, units on a scale.
timeFrame: One assessment within 8 weeks from consent
measure: Short Physical Performance Battery, units on a scale.
timeFrame: One assessment within 8 weeks from consent
measure: Physical functioning - Hand-grip strength, kg.
timeFrame: One assessment within 8 weeks from consent
measure: Self-reported physical activity
timeFrame: One assessment within 8 weeks from consent
measure: Psychosocial wellbeing - Hopelessness, units on a scale.
timeFrame: One assessment within 8 weeks from consent
measure: Psychosocial wellbeing - Social network
timeFrame: One assessment within 8 weeks from consent
measure: Psychosocial wellbeing - Subjective memory complaints, units on a scale.
timeFrame: One assessment within 8 weeks from consent
measure: Psychosocial wellbeing - Anxiety, units on a scale
timeFrame: One assessment within 8 weeks from consent
measure: Psychosocial wellbeing - Depression, units on a scale.
timeFrame: One assessment within 8 weeks from consent
measure: Psychosocial wellbeing - Life events
timeFrame: One assessment within 8 weeks from consent
measure: Psychosocial wellbeing - Sleep quality, units on a scale.
timeFrame: One assessment within 8 weeks from consent
measure: Oral health
timeFrame: One assessment within 8 weeks from consent
measure: Nutritional status, units on a scale.
timeFrame: One assessment within 8 weeks from consent
measure: Dietary habits
timeFrame: One assessment within 8 weeks from consent
measure: Health-related quality of life, units on a scale.
timeFrame: One assessment within 8 weeks from consent
Other outcomes:
measure: Blood pressure, mmHg.
timeFrame: One assessment within 8 weeks from consent
measure: BMI, kg/m2
timeFrame: One assessment within 8 weeks from consent
measure: Waist-hip ratio, cm.
timeFrame: One assessment within 8 weeks from consent
measure: Blood glucose, mmol/L
timeFrame: One assessment within 8 weeks from consent
measure: Glycated hemoglobin, mmol/mol
timeFrame: One assessment within 8 weeks from consent
measure: Cholesterol, mmol/L
timeFrame: One assessment within 8 weeks from consent
measure: LDL cholesterol, mmol/L
timeFrame: One assessment within 8 weeks from consent
measure: HDL, mmol/L
timeFrame: One assessment within 8 weeks from consent
measure: Triglycerides, mmol/L
timeFrame: One assessment within 8 weeks from consent
measure: Creatinine, mg/dl
timeFrame: One assessment within 8 weeks from consent
measure: CRP, mg/L
timeFrame: One assessment within 8 weeks from consent
measure: Smoking habits
timeFrame: One assessment within 8 weeks from consent
measure: Current medications
timeFrame: One assessment within 8 weeks from consent
measure: Medical history
timeFrame: Through study completion, an average of 2 years
measure: Sociodemographic factors
timeFrame: One assessment within 8 weeks from consent
measure: Leisure activities
timeFrame: One assessment within 8 weeks from consent
Locations:
city: Kuopio
country: Finland
facility: University of Eastern Finland
Study officials:
affiliation: University of Eastern Finland
name: Miia Kivipelto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barbera M, Kulmala J, Lisko I, Pietila E, Rosenberg A, Hallikainen I, Hallikainen M, Laatikainen T, Lehtisalo J, Neuvonen E, Rusanen M, Soininen H, Tuomilehto J, Ngandu T, Solomon A, Kivipelto M. Third follow-up of the Cardiovascular Risk Factors, Aging and Dementia (CAIDE) cohort investigating determinants of cognitive, physical, and psychosocial wellbeing among the oldest old: the CAIDE85+ study protocol. BMC Geriatr. 2020 Jul 10;20(1):238. doi: 10.1186/s12877-020-01617-5.