MedPath

Frontotemporal dementia Imaging of Neuroinflammation, Degeneration and Microglia-Related Effects

Recruiting
Conditions
Frontotemporal dementia
FTD
10042258
10012272
Registration Number
NL-OMON49263
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
32
Inclusion Criteria

- Able to tolerate the [18F]DPA-714 PET-MRI scan procedures and to make an
informed decision to participate in this study
- Symptomatic patients must meet clinical criteria for FTD clinical syndromes
- Presymptomatic individuals and healthy controls must show no objective
evidence of cognitive impairment

Exclusion Criteria

- Has contraindications for MRI scanning, e.g. metal objects in the body,
claustrophobia
- Has evidence of structural brain abnormalities that are likely to interfere
with the interpretation of PET scan
- Has one or more comorbidities that may interfere with the outcomes of the
study (e.g. significant immune disease, neurological disease, CNS malignancy)
- Has a history of moderate or severe traumatic brain injury
- Has made use of immunomodulatory or immunosuppressive therapy in the 3 months
prior to the scan
- Has any disease or uses medication that may compromise the function of the
body systems and could interfere with the metabolism of the radiotracer or the
interpretation of the results
- Has an unstable medical condition
- Is pregnant or breastfeeding
- Has a history of severe drug allergy or hypersensitivity
- Has been injected with a previously administered radiopharmaceutical within 6
terminal half-lives OR when the total yearly radiation exposure exceeds 10 mSv
if participating in this protocol
- Is a low-affinity binder for the tracer based on the rs6971 TSPO
polymorphism
- Has a present or past history of alcohol and/or drug abuse
- Makes use of benzodiazepines and is not able to suspend their use during the
week prior to the PET scan

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The quantity and regional distribution of [18F]DPA-714 binding as a marker of<br /><br>microglial activation in patients with FTD compared to healthy controls.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>- Comparison of [18F]DPA-714 binding between patients and presymptomatic gene<br /><br>carriers<br /><br>- Comparison of [18F]DPA-714 binding between presymptomatic gene carriers and<br /><br>healthy controls (i.e. non-carriers)<br /><br>- Correlation of [18F]DPA-714 binding with other MRI measures of<br /><br>neuroinflammation and neurodegeneration<br /><br>- Correlation of [18F]DPA-714 binding with measures of clinical severity and<br /><br>neuropsychological performance<br /><br>- Correlation of [18F]DPA-714 binding with levels of CSF and/or blood<br /><br>biomarkers</p><br>
© Copyright 2025. All Rights Reserved by MedPath