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PREVENTION OF DEMENTIA BY INTENSIVE VASCULAR CARE - OBSERVATIONAL EXTENSION STUDY

PREVENTION OF DEMENTIA BY INTENSIVE VASCULAR CARE - OBSERVATIONAL EXTENSION STUDY - preDIVA-POE study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42949
Enrollment
2700
Registered
2016-11-03
Start date
2017-04-26
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia forgetfulness

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Previous participation in the preDIVA trial Previous consent to be contacted for future research or willingness to consider participation in future research or extended follow up

Exclusion criteria

Exclusion criteria: Subjects of whom no contact information is present. Subjects who have moved out of the country or out of reach for the consultants will not be asked for brain donation, but can be included in prospective data collection (level 1 of the study).

Design outcomes

Primary

MeasureTime frame
The main study endpoint of the study is the clinical diagnosis of dementia (component 1). For subjects participating in post-mortem brain autopsy (component 2), the main study parameter is clinical diagnosis of dementia and its relation to the extent and severity of (micro)vascular changes, neurodegenerative changes, neuroinflammation. Also, the effect of long-term vascular risk factor modification on neuropathological changes including (micro-)vascular damage and neurodegeneration and relation to changes on brain MRI will be studied. In exploratory analyses we will also assess the association between specific clinical variables (a.o. cognition, blood pressure) and neuropathological changes at autopsy. For subjects participating in the qualitative interview study (component 3), the main study parameters are barriers and facilitators for participation in a brain donation program. An independent and blinded outcome adjudication committee will be consulted to evaluate the primary outcome i.e. dementia. This committee will consist of neurologists, old age psychiatrists, geriatricians, general practitioners and cardiologists, who will evaluate all cases using available clinical information.

Secondary

MeasureTime frame
Secondary outcomes, for all levels of the study, are mortality, myocardial infarction, cerebral infarction, transient ischaemic attack, peripheral vascular disease, AMC linear disability score (ALDS), score on mini mental state examination (MMSE) or Telephone Interview for Cognitive Status (TICS), (which can be interpreted in the same way as the MMSE which was used in preDIVA) and mood as assessed with the Geriatric Depression Scale. All these endpoints will be related to the microvascular changes of the brain tissue in subjects consenting to post-mortem autopsy. Medical records of participants can be requested via the general practitioner for additional information on medical status. Other parameters collected in the study will be information on cardiovascular risk management over the past 2 years including visits to the general practitioner. Other variables will include living situation, new comorbidities, hospital admissions, smoking status, alcohol consumption and medication. Weight, height, blood pressure and heart rate will be collected in the participants of the component 2 study.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)