Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2026-03-15 @ 4:14 PM
Study NCT ID:
NCT03938727
Status:
COMPLETED
Last Update Posted:
2022-05-20
First Post:
2019-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Risk Factors, Aging and Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 195}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-19', 'studyFirstSubmitDate': '2019-04-04', 'studyFirstSubmitQcDate': '2019-05-03', 'lastUpdatePostDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Blood pressure, mmHg.', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'Systolic and diastolic blood pressure'}, {'measure': 'BMI, kg/m2', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'Body mass index'}, {'measure': 'Waist-hip ratio, cm.', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'Hip-waist Circumference: measured to nearest 0.1cm'}, {'measure': 'Blood glucose, mmol/L', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'Fasting Glucose'}, {'measure': 'Glycated hemoglobin, mmol/mol', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'Blood level of glycated haemoglobin A1c (HbA1c)'}, {'measure': 'Cholesterol, mmol/L', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'Total blood cholesterol level'}, {'measure': 'LDL cholesterol, mmol/L', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'Blood low density lipoprotein cholesterol level'}, {'measure': 'HDL, mmol/L', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'Blood high density lipoprotein cholesterol level'}, {'measure': 'Triglycerides, mmol/L', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'Blood triglycerides level'}, {'measure': 'Creatinine, mg/dl', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'Blood creatinine level'}, {'measure': 'CRP, mg/L', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'Blood C-reactive protein level'}, {'measure': 'Smoking habits', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'Self-reported questions about smoking status: never/past/current'}, {'measure': 'Current medications', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'Self-reported list of medication currently used'}, {'measure': 'Medical history', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Diagnoses, hospitalizations and other relevant events related to the participants healthcare will be recorded from national registers'}, {'measure': 'Sociodemographic factors', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'Marital status, living/domicile setting, current yearly income, work history.'}, {'measure': 'Leisure activities', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'Self-reported questions inquiring about 12 leisure-time activities.'}], 'primaryOutcomes': [{'measure': 'Cognitive performance, CERAD', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'Finnish version of CERAD (Consortium to Establish a Registry for Alzheimer´s Disease). Score range: 0-100, higher score indicates a better outcome.'}, {'measure': 'Cognitive performance, MMSE', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'Mini Mental State Examination. Score range: 0-30, higher score indicates a better outcome.'}, {'measure': 'Clinical Dementia Rating, units on a scale.', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': '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.'}, {'measure': 'Activity of Daily Living, Katz Index.', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': '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.'}, {'measure': 'Activity of Daily Living, Lawton-Brody Scale.', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': '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.'}, {'measure': 'Dementia and mild cognitive impairment', 'timeFrame': 'Through study completion, an average of 2 years', 'description': "MCI and dementia diagnoses (including type of dementia) will be ascertained from the participants' medical records. Data linkage to national registers."}], 'secondaryOutcomes': [{'measure': 'Multimorbidity', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Total number of diagnoses of concomitant chronic medical conditions ascertained based on medical history data from e.g. previous follow-up data, as well as medical records. Data linkage to national registers.'}, {'measure': 'Frailty Index, units on a scale.', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'Fried Frailty phenotype, defined by assessing five criteria: unintentional weight loss, self-reported exhaustion, weakness by grip strength, slow walking speed, and low physical activity. One point is attributed when each of the five criteria is met. Score range: 0-5, a lower score indicates a better outcome.'}, {'measure': 'Short Physical Performance Battery, units on a scale.', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'Physical performance is assessed in three domains: balance standing (score range: 0-4), chair standing (score range: 0-4), and gait speed (score range: 0-4). The total score (range: 0-12) is the sum of the three scores. A higher score indicates a better outcome.'}, {'measure': 'Physical functioning - Hand-grip strength, kg.', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'The test measures the maximum isometric strength of the hand and forearm muscles and it is carried out with the aid of a hand-grip dynamometer.'}, {'measure': 'Self-reported physical activity', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'Number of days/week in which physical activity is carried out for at least 20 minutes.'}, {'measure': 'Psychosocial wellbeing - Hopelessness, units on a scale.', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'Self-reported questions inquiring about sense of hopelessness.'}, {'measure': 'Psychosocial wellbeing - Social network', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'Self-reported questions inquiring about social network.'}, {'measure': 'Psychosocial wellbeing - Subjective memory complaints, units on a scale.', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': '22-item self-reported questionnaire inquiring on subjective memory. Score range: 0-66, a lower score indicates a better outcome.'}, {'measure': 'Psychosocial wellbeing - Anxiety, units on a scale', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'State Trait Anxiety Inventory (STAI -6), self-reported 6-item questionnaire inquiring about sense of anxiety. Score range: 0-18, a lower score indicates a better outcome.'}, {'measure': 'Psychosocial wellbeing - Depression, units on a scale.', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'Beck Depression Inventory (BDI), a 21-item self-reported questionnaire including inquiring about symptoms of depression. Score range: 0-63. A lower score indicates a better outcome.'}, {'measure': 'Psychosocial wellbeing - Life events', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'Self-reported list of 12 significant life events.'}, {'measure': 'Psychosocial wellbeing - Sleep quality, units on a scale.', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'Pittsburgh Sleep Quality Index (PSQI), measuring the quality and patterns of sleep in older adults. Score range 0-21. A lower score indicates a better outcome.'}, {'measure': 'Oral health', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'Self-reported questions inquiring about oral health.'}, {'measure': 'Nutritional status, units on a scale.', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': "Mini Nutritional Assessment (MNA), a screening tool specifically designed for older adults to help identify elderly people who are malnourished or at risk of malnutrition. The assessment consists of six items evaluated by the assessor. A score (0-3 or 0-2) is attributed to each item based on the assessor's evaluation. The overall score ranges 0-14, and a higher score indicates a better outcome."}, {'measure': 'Dietary habits', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'Self-reported questions inquiring about dietary habits.'}, {'measure': 'Health-related quality of life, units on a scale.', 'timeFrame': 'One assessment within 8 weeks from consent', 'description': 'RAND 36-Item Health Survey 1.0, a 36-item self-reported questionnaire inquiring about health related quality of life. Score range: 0-100, a higher score indicates a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dementia', 'Aging', "Alzheimer's Disease", 'Cognition', 'Frailty', 'Epidemiology', 'Lifestyle', 'Cardiovascula Risk Factors'], 'conditions': ['Dementia']}, 'referencesModule': {'references': [{'pmid': '32650731', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nCAIDE85+ 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.", 'detailedDescription': "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.\n\nThe 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.\n\nTen 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.\n\nCAIDE85+ 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.\n\nPotential 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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previous invitation to the first CAIDE follow up (1998)\n* Being still alive and living in the Kuopio and Joensuu areas (Finland)\n\nExclusion Criteria:\n\n* No exclusion criteria'}, 'identificationModule': {'nctId': 'NCT03938727', 'acronym': 'CAIDE', 'briefTitle': 'Cardiovascular Risk Factors, Aging and Dementia', 'organization': {'class': 'OTHER', 'fullName': 'University of Eastern Finland'}, 'officialTitle': 'Cardiovascular Risk Factors, Aging and Dementia (III Follow-up)', 'orgStudyIdInfo': {'id': 'CAIDE85+'}}, 'contactsLocationsModule': {'locations': [{'city': 'Kuopio', 'country': 'Finland', 'facility': 'University of Eastern Finland', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}], 'overallOfficials': [{'name': 'Miia Kivipelto, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Eastern Finland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Eastern Finland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Finnish Institute for Health and Welfare', 'class': 'OTHER_GOV'}, {'name': 'Kuopio University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}