To study the longitudinal dynamics of blood biomarkers, including NfL, in patients with frontotemporal dementia.
ID
Source
Brief title
Condition
- Structural brain disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Longitudinal dynamics of biomarkers in blood of patients with frontotemporal
dementia
2. Relationship between longitudinal change of blood biomarkers and severity
and rate of cognitive decline in patients with frontotemporal dementia.
Secondary outcome
NA.
Background summary
Of all patients with dementia, 5-10% suffer from frontotemporal dementia (FTD).
It is the second most common cause of early onset dementia (<65 years). FTD is
characterised by early behavioural and/or language impairment. Its clinical
course is highly variable but inevitably leads to progressive cognitive
decline. As of yet, there are no medical treatments to stop or slow down
disease progression.
In recent years, the development of biomarkers for dementia has gathered much
interest. Ideally, a biomarker in blood could contribute to early diagnosis and
prediction of disease progression. Additionally, these blood biomarkers could
be used to monitor effects of treatment in future medication trials. A very
promising blood biomarker in FTD is neurofilament light chain (NfL). This
protein is present in much larger quantities in FTD patients than in controls.
Other such blood biomarkers are currently being researched.
As of yet, the study of blood biomarkers in FTD has been restricted to
cross-sectional analyses. In order to apply biomarkers for medication trials in
the future, it is essential to understand the longitudinal dynamics.
In this study, we aim to unravel the longitudinal dynamics of blood biomarkers,
including NfL, in patients with FTD, by obtaining longitudinal blood samples
and clinical information on disease progression.
Study objective
To study the longitudinal dynamics of blood biomarkers, including NfL, in
patients with frontotemporal dementia.
Study design
Prospective observational study.
Study burden and risks
For this study, participants will be asked to visit the outpatient clinic of
the Neurology department of the Erasmus MC annually for three consecutive
years. During each visit, several validated questionnaires are filled out
concerning cognitive functioning. A blood sample (total 34 ml) is collected
through venipuncture. The risks of venipuncture are minimal; a possible risk is
development of a hematoma at the puncture site.
The duration of each annual visit is roughly 45 minutes.
Whenever possible, visits will be planned in conjunction with regular
outpatient appointments. If desired, patients and caregivers can opt for a
study visit at the place of residence of the patient. These measures attempt to
minimise the required effort from the patient and their caregiver.
's Gravendijkwal 230
Rotterdam 3015CE
NL
's Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
Inclusion criteria
Patients with frontotemporal dementia who visited our referral centre and were diagnosed according to International Consensus Criteria. All clinical subtypes will be included, both genetic and sporadic.
Exclusion criteria
Patients with a history of unrelated neurological disorders that could influence cognitive performance (such as normal pressure hydrocephalus, brain tumours, developmental disorders et cetera).
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 | NL63268.078.17 |