NCT03938727

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

June 14, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

May 20, 2022

Status Verified

May 1, 2022

Enrollment Period

1.5 years

First QC Date

April 4, 2019

Last Update Submit

May 19, 2022

Conditions

Keywords

DementiaAgingAlzheimer's DiseaseCognitionFrailtyEpidemiologyLifestyleCardiovascula Risk Factors

Outcome Measures

Primary Outcomes (6)

  • Cognitive performance, CERAD

    Finnish version of CERAD (Consortium to Establish a Registry for Alzheimer´s Disease). Score range: 0-100, higher score indicates a better outcome.

    One assessment within 8 weeks from consent

  • Cognitive performance, MMSE

    Mini Mental State Examination. Score range: 0-30, higher score indicates a better outcome.

    One assessment within 8 weeks from consent

  • Clinical Dementia Rating, units on a scale.

    Influence of cognitive impairment on the ability to conduct everyday activities on six domains (memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care). Score ranges: 0-3 (individual domain), 0-18 (total score as sum of the six domains). Lower score indicates a better outcome.

    One assessment within 8 weeks from consent

  • Activity of Daily Living, Katz Index.

    Self-reported questionnaire ranking the independence in six basic daily functions. For each activity, the participant is rated either dependent (0 points) or independent (1 point). The total score score ranges 0-6 and a higher score indicates a better outcome.

    One assessment within 8 weeks from consent

  • Activity of Daily Living, Lawton-Brody Scale.

    Self-reported questionnaire assessing the level of functioning in eight daily activities necessary for living in the community. For each activity, the participant is rated either dependent (0 points) or independent (1 point). Score ranges 0-8 and a higher score indicates a better outcome.

    One assessment within 8 weeks from consent

  • Dementia and mild cognitive impairment

    MCI and dementia diagnoses (including type of dementia) will be ascertained from the participants' medical records. Data linkage to national registers.

    Through study completion, an average of 2 years

Secondary Outcomes (16)

  • Multimorbidity

    Through study completion, an average of 2 years

  • Frailty Index, units on a scale.

    One assessment within 8 weeks from consent

  • Short Physical Performance Battery, units on a scale.

    One assessment within 8 weeks from consent

  • Physical functioning - Hand-grip strength, kg.

    One assessment within 8 weeks from consent

  • Self-reported physical activity

    One assessment within 8 weeks from consent

  • +11 more secondary outcomes

Other Outcomes (16)

  • Blood pressure, mmHg.

    One assessment within 8 weeks from consent

  • BMI, kg/m2

    One assessment within 8 weeks from consent

  • Waist-hip ratio, cm.

    One assessment within 8 weeks from consent

  • +13 more other outcomes

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Eastern Finland

Kuopio, Finland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DementiaAlzheimer DiseaseFrailty

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Miia Kivipelto, MD, PhD

    University of Eastern Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2019

First Posted

May 6, 2019

Study Start

June 14, 2019

Primary Completion

December 21, 2020

Study Completion

January 31, 2021

Last Updated

May 20, 2022

Record last verified: 2022-05

Locations