The aim of this research is to study which biological processes precede and can predict loss of brain connectivity in a longitudinal study in 55 individuals with predementia AD, for whom a potential intervention may have maximal effect.This research…
ID
Source
Brief title
Condition
- Neurological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main predictor: baseline and longitudinal biological processes measured with
CSF proteomics.
Main endpoints: decline in brain network measures over time compared to
baseline.
Secondary outcome
Secondary endpoints:
- Decline in cognitive functioning over time compared to baseline as measured
with a neuropsychological test battery
- Progression to dementia
Background summary
The most common cause of dementia is Alzheimer*s disease (AD). AD starts with
amyloid beta aggregation in the brain, 20 years before the onset of dementia.
This long time period provides opportunities to prevent dementia. We have
previously developed methodology to measure brain connectivity using a routine
structural MRI scan. Our research showed that loss of brain connectivity is
central to the clinical manifestation of AD. We propose to investigate the
biological processes associated with disrupted brain connectivity in AD to find
new leads for dementia prevention.
We will use a combined cerebrospinal fluid (CSF) proteomics and multimodal
magnetic resonance imaging (MRI) approach to identify biological processes in
the brain that are associated with loss of brain connections in early AD.
Study objective
The aim of this research is to study which biological processes precede and can
predict loss of brain connectivity in a longitudinal study in 55 individuals
with predementia AD, for whom a potential intervention may have maximal effect.
This research will generate new knowledge on the biological processes that
underlie disrupted brain connectivity in AD, which is crucial for developing
novel treatments that delay or even prevent dementia.
Study design
This study is a 3-year prospective longitudinal study
Study burden and risks
Before inclusion from the memory clinic, patients have been screened at the
Alzheimer Center Amsterdam, including comprehensive neuropsychological testing,
MRI imaging and collection of blood and CSF. When patients participate in this
study, they will receive repeated MRI imaging and CSF withdrawal three times
within approximately 2 years. If possible, visits will be planned consecutively
to routine clinical follow-up which includes neuropsychological testing. The
lumbar puncture is a common procedure in neurology practice. Our researchers
have a lot of experience in the procedure and it has been proven to be safe. An
MRI scan is a widely used imaging technique in medical practice. It can cause
discomfort but the risks are negligible. There is no direct benefit for the
participant. Participants will contribute valuable information to dementia
research, which will be a benefit for future patients with AD. As the risks are
low and the outcome of the project is very valuable for dementia research, we
consider the burden to be acceptable.
De Boelelaan 1118
Amsterdam 1081HV
NL
De Boelelaan 1118
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
- Clinical diagnosis of mild cognitive impairment due to Alzheimer's Disease
- Abnormal CSF biomarker for aggregated amyloid
- Signed informed consent for Amsterdam Dementia Cohort (ADC) (P2016.061) and
Amsterdam Dementia Biobank (P2017.315)
- Age >=50 years
Exclusion criteria
- No CSF collection or MRI-imaging at screening at memory clinic
- Clinical diagnosis of dementia or subjective cognitive decline
- Other neurological diagnosis, such as Parkinson*s disease, symptomatic
stroke, mental retardation, brain tumor or infection, likely to be cause of
cognitive impairment
- Major psychiatric disorder, such as psychosis, schizophrenia, depression with
vital signs, severe personality disorder, abuse of alcohol or other substances,
likely to be cause of cognitive impairment
- Use of (oral) anticoagulants or other contraindications for lumbar puncture
- Contraindications for MRI scan (e.g., metal implants, pacemaker)
Design
Recruitment
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 | NL77598.029.21 |