The aim of this study is two-fold:1.To elucidate the role of neuroinflammation in FTLD2.To identify biomarkers to predict and monitor disease progression in FTLD3.To differentiate FTLD-TDP from FTLD-tau during life using biomarkers for…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences between patients with FTLD-TDP, patients with FTLD-tau in the
symptomatic and presymptomatic stage and healthy controls in CSF and MRI
measures for neuroinflammation and correlation with clinical measures at
baseline and follow-up.
Secondary outcome
na
Background summary
Frontotemporal lobar degeneration (FTLD) presents with variable degrees of
behavioral disturbances, language and executive dysfunction and parkinsonism,
with major impact on daily live functioning, for which no cure is available.
Insight in the pathophysiology is crucial for treatment development. Recent
research convincingly shows that neuroinflammation occurs in FTLD, however its
role in the disease process is unknown. We will use a multimodal biomarker
approach, including high-field 7T MRI and fluid biomarkers, to elucidate the
role of neuroinflammation in the disease and thereby determine the potential of
anti-inflammatory drugs to alter the disease course and to identify appropriate
biomarkers for upcoming clinical trials.
Study objective
The aim of this study is two-fold:
1.To elucidate the role of neuroinflammation in FTLD
2.To identify biomarkers to predict and monitor disease progression in FTLD
3.To differentiate FTLD-TDP from FTLD-tau during life using biomarkers for
neuroinflammation
Study design
Longitudinal observational study
Study burden and risks
The study includes a baseline visit in the Erasmus Medical Center and in the
Leiden University Medical Center and a follow-up visit in the Erasmus Medical
Center after one year. In the Leiden University Medical Center participants
will undergo a 7T MRI scan, which has no known health consequences.
Contraindications for MRI will be carefully checked. In the Erasmus Medical
Center, participants will undergo physical and neuropsychological evaluation,
and a vena puncture at baseline and follow-up and a lumbar puncture only at
baseline. Physical and neuropsychological evaluation have no known health
risks. The risk of lumbar punctures is almost negligible, as long a
contraindications are carefully checked. With the use of a thin, non-traumatic,
needle the risk of a headache, which is the most common complication, is less
than 10%. Other complications such as meningitis and subdural spinal haematoma
are extremely rare.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
- Ability to undergo MRI scanning
- For probable FTLD-tau: a clinical diagnosis of PSP, CBS or nfvPPA, or any
clinical FTLD spectrum diagnosis with a proven MAPT mutation
- For probable FTLD-TDP: a clinical diagnosis of svPPA or any clinical FTLD
spectrum diagnosis with a proven GRN mutation or C9orf72 repeat expansion
- For presymptomatic mutation carriers: a MAPT mutation, GRN mutation or a
C9orf72 mutation withouth clinical sign of a FTLD spectrum phenotype (CDR 0)
- For control subjects: no known neurological or psychiatric disorder
Exclusion criteria
- Other neurological or psychiatric disorder that may affect cognitive
functions, such as a brain tumour, multiple sclerosis or drug or alcohol abuse
or use of psycho-active medications
- CSF profile (β-amyloid, p-tau, t-tau) suggestive of AD pathology
- Clinical dementia Rating Scale (CDR) score >1
- Contra-indication to undergo MRI
- Contra-indication to undergo lumbar puncture
Design
Recruitment
Medical products/devices used
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 | NL78272.058.21 |