DementiaCAIDENCT03938727
Cardiovascular Risk Factors, Aging and Dementia
An observational study of Dementia, run by University of Eastern Finland at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dementia
- How many people
- 195 participants
- Where
- 1 siteFinland
- Study dates
- 14 Jun 2019to 31 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Previous invitation to the first CAIDE follow up (1998)
- Being still alive and living in the Kuopio and Joensuu areas (Finland)
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiovascular Risk Factors, Aging and Dementia (III Follow-up)
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.
Read the 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).
- Conditions
- Dementia
- Keywords
- Dementia, Aging, Alzheimer's Disease, Cognition, Frailty, Epidemiology, Lifestyle, Cardiovascula Risk Factors
- Medical subject headings
- Dementia, Alzheimer Disease, Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One assessment within 8 weeks from consent
Cognitive performance, MMSE
Mini Mental State Examination. Score range: 0-30, higher score indicates a better outcome.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 2 years
Secondary outcomes (16)
Multimorbidity
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.
Measured: Through study completion, an average of 2 years
Frailty Index, units on a scale.
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.
Measured: One assessment within 8 weeks from consent
Short Physical Performance Battery, units on a scale.
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.
Measured: One assessment within 8 weeks from consent
Physical functioning - Hand-grip strength, kg.
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.
Measured: One assessment within 8 weeks from consent
Self-reported physical activity
Number of days/week in which physical activity is carried out for at least 20 minutes.
Measured: One assessment within 8 weeks from consent
Psychosocial wellbeing - Hopelessness, units on a scale.
Self-reported questions inquiring about sense of hopelessness.
Measured: One assessment within 8 weeks from consent
Psychosocial wellbeing - Social network
Self-reported questions inquiring about social network.
Measured: One assessment within 8 weeks from consent
Psychosocial wellbeing - Subjective memory complaints, units on a scale.
22-item self-reported questionnaire inquiring on subjective memory. Score range: 0-66, a lower score indicates a better outcome.
Measured: One assessment within 8 weeks from consent
Psychosocial wellbeing - Anxiety, units on a scale
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.
Measured: One assessment within 8 weeks from consent
Psychosocial wellbeing - Depression, units on a scale.
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.
Measured: One assessment within 8 weeks from consent
Psychosocial wellbeing - Life events
Self-reported list of 12 significant life events.
Measured: One assessment within 8 weeks from consent
Psychosocial wellbeing - Sleep quality, units on a scale.
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.
Measured: One assessment within 8 weeks from consent
Oral health
Self-reported questions inquiring about oral health.
Measured: One assessment within 8 weeks from consent
Nutritional status, units on a scale.
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.
Measured: One assessment within 8 weeks from consent
Dietary habits
Self-reported questions inquiring about dietary habits.
Measured: One assessment within 8 weeks from consent
Health-related quality of life, units on a scale.
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.
Measured: One assessment within 8 weeks from consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start14 Jun 2019
- Primary completion21 Dec 2020
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Collaborators
- Finnish Institute for Health and Welfare, Kuopio University Hospital
- Responsible party
- Sponsor
- Investigators
- Miia Kivipelto, MD, PhD, Principal investigator, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938727
- Sponsor's protocol ID
- CAIDE85+
- Acronym
- CAIDE
- Status last verified
- May 2022
- First submitted
- 4 Apr 2019
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32650731
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk Factors, Aging and Dementia (III Follow-up)
- ClinicalTrials.gov ID
- NCT03938727
- Acronym / sponsor ID
- CAIDE / CAIDE85+
- Conditions
- Dementia
- Keywords
- Dementia, Aging, Alzheimer's Disease, Cognition, Frailty, Epidemiology, Lifestyle, Cardiovascula Risk Factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Collaborators
- Finnish Institute for Health and Welfare, Kuopio University Hospital
- Study start
- 14 Jun 2019 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Previous invitation to the first CAIDE follow up (1998)
- Being still alive and living in the Kuopio and Joensuu areas (Finland)
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive performance, CERAD
Time frame: One assessment within 8 weeks from consent
Finnish version of CERAD (Consortium to Establish a Registry for Alzheimer´s Disease). Score range: 0-100, higher score indicates a better outcome.
Cognitive performance, MMSE
Time frame: One assessment within 8 weeks from consent
Mini Mental State Examination. Score range: 0-30, higher score indicates a better outcome.
Clinical Dementia Rating, units on a scale.
Time frame: One assessment within 8 weeks from consent
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.
Activity of Daily Living, Katz Index.
Time frame: One assessment within 8 weeks from consent
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.
Activity of Daily Living, Lawton-Brody Scale.
Time frame: One assessment within 8 weeks from consent
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.
Dementia and mild cognitive impairment
Time frame: Through study completion, an average of 2 years
MCI and dementia diagnoses (including type of dementia) will be ascertained from the participants' medical records. Data linkage to national registers.
16 secondary outcomes
Multimorbidity
Time frame: Through study completion, an average of 2 years
Frailty Index, units on a scale.
Time frame: One assessment within 8 weeks from consent
Short Physical Performance Battery, units on a scale.
Time frame: One assessment within 8 weeks from consent
Physical functioning - Hand-grip strength, kg.
Time frame: One assessment within 8 weeks from consent
Self-reported physical activity
Time frame: One assessment within 8 weeks from consent
Psychosocial wellbeing - Hopelessness, units on a scale.
Time frame: One assessment within 8 weeks from consent
Psychosocial wellbeing - Social network
Time frame: One assessment within 8 weeks from consent
Psychosocial wellbeing - Subjective memory complaints, units on a scale.
Time frame: One assessment within 8 weeks from consent
Psychosocial wellbeing - Anxiety, units on a scale
Time frame: One assessment within 8 weeks from consent
Psychosocial wellbeing - Depression, units on a scale.
Time frame: One assessment within 8 weeks from consent
Psychosocial wellbeing - Life events
Time frame: One assessment within 8 weeks from consent
Psychosocial wellbeing - Sleep quality, units on a scale.
Time frame: One assessment within 8 weeks from consent
Oral health
Time frame: One assessment within 8 weeks from consent
Nutritional status, units on a scale.
Time frame: One assessment within 8 weeks from consent
Dietary habits
Time frame: One assessment within 8 weeks from consent
Health-related quality of life, units on a scale.
Time frame: One assessment within 8 weeks from consent
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Derived from this study: PubMed 32650731Barbera 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.
Related trials for Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miia Kivipelto, MD, PhD principal investigator
University of Eastern Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by University of Eastern Finland at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive performance, CERAD (time frame: One assessment within 8 weeks from consent). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03938727, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.