To identify novel diagnostic and prognostic (bio)markers of Dementia with Lewy Bodies.
ID
Source
Brief title
Condition
- Chromosomal abnormalities, gene alterations and gene variants
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The development of a study database and biobank for the identification of new
diagnostic and prognostic (bio)markers of Dementia with Lewy Bodies.
Secondary outcome
To identify DNA and CSF proteome alterations in familial DLB that could be used
as biomarkers of Dementia with Lewy Bodies.
Background summary
Dementia with Lewy Bodies is the second most common dementia in the elderly
after Alzheimer*s Disease. Diagnosing Dementia with Lewy Bodies is difficult
because of the highly variable symptoms of the disease and the considerable
overlap of symptoms with Alzheimer's disease and Parkinson*s Disease. In
addition, there is a lack of diagnostic as well as prognostic markers for
Dementia with Lewy Bodies. A timely diagnosis will improve treatment and care
for patients and their caregivers and will help in the selection of appropriate
patients for clinical trials and the development of disease modifying
treatment. Prognostic markers will further improve treatment and care of
patients with Dementia with Lewy Bodies. This will lead to a higher quality of
life and will reduce health care costs. Identifying novel clinical, imaging,
blood and cerebrospinal fluid markers of Dementia with Lewy Bodies will highly
contribute to these aims.
Study objective
To identify novel diagnostic and prognostic (bio)markers of Dementia with Lewy
Bodies.
Study design
A multicenter prospective clinical cohort study which includes a
cross-sectional multicenter family substudy.
Study burden and risks
In this study patients will be examined once a year. Clinical data, brain MRI
scans, blood and cerebrospinal fluid samples will be collected. In the family
substudy, blood, cerebrospinal fluid samples and skin cells will be collected
once. Regular clinical visits will be combined with data collection for this
study. Therefore the burden of additional time is relatively low. There are no
major risks associated with MRI-scanning, as no contrast enhancement is needed.
The risk of a venapuncture is the occurrence of a hematoma. The risk associated
with a lumbar puncture is low. A common complication is post-lumbar puncture
headache, observed in 1-5% of patients. This risk is greatly reduced at higher
age and with the use of a non-traumatic needle. Other complications such as
meningitis and subdural spinal haematoma are very rare. Adverse events of skin
biopsy may include minor bruising, local tenderness and a very low risk of
infection. Participating in this study has no advantage for the specific
individual. However, the relatively low burden of the individual could yield
much information on the early phases of DLB. This is highly relevant to improve
care of DLB patients in the future.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
Patients with (prodromal) Dementia with Lewy Bodies or (prodromal) Parkinson's Disease Dementia (including patients without mild cognitive impairment).
Exclusion criteria
Mini Mental State Examination lower than 20 out of 30 points.
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 | NL53037.078.15 |