Imaging of neuroinflammation in frontotemporal dementia by means of PET-MRI
- Conditions
- Frontotemporal dementia (FTD), including symptomatic patients and presymptomatic individuals with genetic mutations predisposing to FTD at a later stage in life.Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2020-002672-12-NL
- Lead Sponsor
- Erasmus Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 32
- 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 27
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
- 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
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method