Prevention of Dementia by Intensive Vascular Care - MRI sub-study

Prevention of Dementia by Intensive Vascular Care - MRI sub-study - preDIVA-M

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36576

Enrollment

150

Registered

2011-03-07

Start date

2011-03-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

cognitive decline dementia

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Elderly subjects aged 72-80 with no dementia and a systolic blood pressure above 140 mmHg

Exclusion criteria

Exclusion criteria: Dementia, limited life-expectancy due to any medical condition

Design outcomes

Primary

Measure	Time frame
The main outcome parameters of this study are radiological. Increase in cerebrovascular lesions over a 4-year interval will be scored by raters blinded to any clinical information including the treatment allocation in the preDIVA-trial. - White matter lesion progression using visual rating scales, as well as volumetric analysis. - Presence of cerebral infarcts at baseline and occurrence of new cerebral infarcts during the 4-year follow-up. Infarcts will be counted on baseline and follow-up scans.	—

Measure

Time frame

The main outcome parameters of this study are radiological. Increase in cerebrovascular lesions over a 4-year interval will be scored by raters blinded to any clinical information including the treatment allocation in the preDIVA-trial. - White matter lesion progression using visual rating scales, as well as volumetric analysis. - Presence of cerebral infarcts at baseline and occurrence of new cerebral infarcts during the 4-year follow-up. Infarcts will be counted on baseline and follow-up scans.

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Secondary

Measure	Time frame
Secondary endpoints: - Progression of hippocampal atrophy and global cerebral atrophy, using both visual rating scales as well as volumetric analysis. - Correlation of progression of cerebrovascular lesions with clinical data from the preDIVA-trial, such as vascular risk factors. - Correlation of progression of cerebrovascular lesions with clinimetrical information which is collected in the preDIVA-trial, including cognitive testing and handicap.	—

Measure

Time frame

Secondary endpoints: - Progression of hippocampal atrophy and global cerebral atrophy, using both visual rating scales as well as volumetric analysis. - Correlation of progression of cerebrovascular lesions with clinical data from the preDIVA-trial, such as vascular risk factors. - Correlation of progression of cerebrovascular lesions with clinimetrical information which is collected in the preDIVA-trial, including cognitive testing and handicap.

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Countries

Netherlands

Outcome results