Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06322121
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2023-12-11
Brief Title:
Vascular Aspects in Dementia Part 2
Sponsor:
Leiden University Medical Center
Organization:
Leiden University Medical Center
Study Overview
Official Title:
Clarifying the Vascular Aspects of Dementia Natural History Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cerebral amyloid angiopathy CAA a common cerebrovascular small vessel disease SVD is a frequently 98 found co-morbidity at autopsy in patients with Alzheimers disease AD Current in vivo hallmarks of CAA represent changes relatively late in the disease process and leaves CAA in AD often undetected Recently it was shown that decreased vascular reactivity VR measured with blood oxygen level dependent BOLD MRI after visual stimulus is an early CAA marker With BOLD-MRI to detect decreased VR in different stages of AD it was shown that increasing stages of AD associate with decreasing VR independent of age classic SVD markers and atrophy Moreover VR is associated with cognitive deficits Therefore cross-sectional data indicate that decreased VR is an important co-morbidity already in early stages of AD with an independent effect on disease severity In this respect the study aim is to determine the natural course of the decrease of VR in both controls and early stage AD patients to monitor AD disease progression This is an essential step to aid in the development and application of effective treatment as it is expected that CAA can causeworsen AD pathology
Detailed Description:
Rationale Cerebral amyloid angiopathy CAA a common cerebrovascular small vessel disease SVD is a frequently 98 found co-morbidity at autopsy in patients with Alzheimers disease AD Current in vivo hallmarks of CAA represent changes relatively late in the disease process and leaves CAA in AD often undetected Recently it was shown that decreased vascular reactivity VR measured with blood oxygen level dependent BOLD MRI after visual stimulus is an early CAA marker With BOLD-MRI to detect decreased VR in different stages of AD it was shown that increasing stages of AD associate with decreasing VR independent of age classic SVD markers and atrophy Moreover VR is associated with cognitive deficits Therefore cross-sectional data indicate that decreased VR is an important co-morbidity already in early stages of AD with an independent effect on disease severity In this respect the study aim is to determine the natural course of the decrease of VR in both controls and early stage AD patients to monitor AD disease progression This is an essential step to aid in the development and application of effective treatment as it is expected that CAA can causeworsen AD pathology
Objective To investigate longitudinal changes in VR in patients with subjective cognitive impairment SCI mild cognitive impairment MCI and AD dementia compared with controls To investigate whether VR predicts progression of disease severity cognitive decline over a time period of 3 years and to investigate if decreased VR at baseline predicts increasing severity of other MRI markers for AD and SVD-markers at follow-up
Study design an longitudinal observational case - control study
Study population 30 AD patients 30 patients with mild cognitive impairment and 30 patients with subjective cognitive impairment plus 30 controls 50-90 yr old
Main study parametersendpoints 1 3T MRI the amplitude of the BOLD response in percentage signal change between stimulus on and off time-to-peak response sec and time-to-baseline sec after discontinuation of the visual stimulus classic signs of CAA intracranial hemorrhage lobar microbleeds subarachnoidal hemorrhage and superficial siderosis and SVD markers number of small subcortical infarcts and lacunes volume of white matter hyperintensities WMHs perivascular spaces in the basal ganglia and centrum semiovale number and location of deep microbleeds and grey matter volume 2 Neuropsychological assessment 3 Baseline characteristics 4 DNA APOE ε genotype
Nature and extent of the burden and risks associated with participation benefit and group relatedness This is a non-therapeutic group relatedness study in only capacitated subjects In order to achieve the aim of the study AD patients are needed Vascular reactivity has potential to determine the role of the vascular aspects in AD The risks of this research are minimal risk of every day life because there are no consequences to the health of the participant We will keep the burden at a minimum The research will consist of a 60 minutes MRI scan a neuropsychological assessment of 1 hour and collection of 2 ml saliva if not already collected at baseline
Objective To investigate longitudinal changes in VR in patients with subjective cognitive impairment SCI mild cognitive impairment MCI and AD dementia compared with controls To investigate whether VR predicts progression of disease severity cognitive decline over a time period of 3 years and to investigate if decreased VR at baseline predicts increasing severity of other MRI markers for AD and SVD-markers at follow-up
Study design an longitudinal observational case - control study
Study population 30 AD patients 30 patients with mild cognitive impairment and 30 patients with subjective cognitive impairment plus 30 controls 50-90 yr old
Main study parametersendpoints 1 3T MRI the amplitude of the BOLD response in percentage signal change between stimulus on and off time-to-peak response sec and time-to-baseline sec after discontinuation of the visual stimulus classic signs of CAA intracranial hemorrhage lobar microbleeds subarachnoidal hemorrhage and superficial siderosis and SVD markers number of small subcortical infarcts and lacunes volume of white matter hyperintensities WMHs perivascular spaces in the basal ganglia and centrum semiovale number and location of deep microbleeds and grey matter volume 2 Neuropsychological assessment 3 Baseline characteristics 4 DNA APOE ε genotype
Nature and extent of the burden and risks associated with participation benefit and group relatedness This is a non-therapeutic group relatedness study in only capacitated subjects In order to achieve the aim of the study AD patients are needed Vascular reactivity has potential to determine the role of the vascular aspects in AD The risks of this research are minimal risk of every day life because there are no consequences to the health of the participant We will keep the burden at a minimum The research will consist of a 60 minutes MRI scan a neuropsychological assessment of 1 hour and collection of 2 ml saliva if not already collected at baseline
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None