We aim to assess the association between (cardio-)vascular and hemodynamic factors in relation to cognitive function.
ID
Source
Brief title
Condition
- Heart failures
- Dementia and amnestic conditions
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cognitive functioning as measured by severity of cognitive impairment on the
Clinical Dementia Rating Scale, the MMSE, 15 word verbal learing test
(15-WVLT), Stroop interference test, Trail making test, digit span test and the
Category fluency test.
Secondary outcome
Structural and functional brain MRI, cerebral perfusion on MRI, daily
functioning as measured by the Amsterdam IADL Questionnaire and Disability
Assessment of Dementia, symptoms of depression as measured with the 15-item
Geriatric Depression Scale, symptoms of apathy as measured with the Starkstein
Apathy Scale.
Background summary
Cardiovascular diseases are increasingly recognized as an independent cause of
and contributor to cognitive decline. Patients with vascular cognitive
impairment (VCI), carotid occlusive disease (COD) and patients with heart
failure (HF) each represent a dysfunction of part of the heart-brain axis.
Available data suggest that hemodynamic balance in the heart-brain axis is
crucial in maintaining functional and structural integrity of the brain and
thereby cognitive functioning. More research is necessary to more precisely
establish the relation between hemodynamic abnormalities, possibly mediated
through altered brain structure and perfusion, and vascular cognitive
impairment.
Study objective
We aim to assess the association between (cardio-)vascular and hemodynamic
factors in relation to cognitive function.
Study design
Prospective observational multicenter study with a follow up period of two
years. All subjects will undergo the same standardized set of clinical,
neuropsychiatric and imaging tests to assess cardiovascular risk factors and
disease, structural and functional brain and cardiac status, cognitive
dysfunctioning, daily functioning and presence of neuropsychiatric symptoms.
After two years assessment of daily functioning and neuropsychiatric symptoms
including cognitive function and brain MRI will be repeated.
Study burden and risks
All research data are collected through standard medical procedures and no
experimental intervention is conducted. The additional risk of this study is
considered negligible. The burden of participation consists of time investment
at both baseline and follow up (120 minutes for clinical assessment and
neuropsychological testing, a maximum of 60 minutes for MRI scanning) and the
fact that a venous blood sample is required. However, this study will
contribute to knowledge of hemodynamic factors associated with cognitive
decline which form possible targets for future therapy.
Addendum January 2015: In the MRI study the contrast agent gadolinium was added
to the. This may change the risk classification.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Patients with vascular cognitive impairment with MMSE ><= 20, carotid occlusive
disease of heart failure are included. Further inclusion criteria are age 50+
years, able to undergo cognitive testing, independence in daily life.
Exclusion criteria
Contraindication for magnetic resonance imaging (MRI) testing
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46484.058.13 |