Status:
ENROLLING_BY_INVITATION
Characterization of Cerebral Tau Aggregates With 18F-RO6958948 PET in the ALFA Population
Lead Sponsor:
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Collaborating Sponsors:
Hoffmann-La Roche
Hospital Clinic of Barcelona
Conditions:
Healthy
Mild Cognitive Impairment
Eligibility:
All Genders
45+ years
Phase:
NA
Brief Summary
This study will characterize tau tracer retention by Positron Emission Tomography (PET) as a function of amyloid levels transversally and longitudinally.
Detailed Description
CROSS-SECTIONAL OBJECTIVES * To measure 18F-RO6958948 retention in selected participants of ALFA-related studies as a function of amyloid levels. * To study the relation between 18F-RO6958948 retenti...
Eligibility Criteria
Inclusion
- To sign the study informed consent form approved by the corresponding authorities.
- Men and women that have participated in a BBRC-sponsored study, including the ALFA project (STUDY 45-65 FPM/2012), the ALFA+ cohort study (ALFA - FPM - 0311), the ALFA cognition study (ALFAcognition/BBRC2017) or the BarcelonaBeta Dementia Prevention Research Clinic study (BBRC-DemPrev-2018).
- Participants with an available cerebral MRI within the last 12 months not suggestive of radiological incidental findings constituting an exclusion criterion.
- Known cognitive status based on the cognitive workup of the BBRC-sponsored studies specified above. Cognitive status should have been determined within the last 12 months.
- Known AB and tau status.
- Good knowledge of the language and being literate.
- Female participants should be post-menopausal or present a negative pregnancy test at the moment of PET acquisition.
Exclusion
- Presence of clinically relevant psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria: major depressive disorder, generalized anxiety disorder, schizophrenia and bipolar disorder, as assessed in the BBRC-sponsored studies specified above.
- Participants with visual and/or hearing impairment.
- History of encephalitis, ictus or seizures excluding feverish convulsions during childhood, as assessed in the BBRC-sponsored studies specified above.
- Severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumour (metastasis/brain cancer) as verified by MRI.
- Previous participation in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening and/or administration of a radiopharmaceutical within 10 radioactive half-lives prior to study drug administration in this study.
- Clinically relevant renal or hepatic insufficiency.
- Any other clinically important condition that may jeopardize the study or be dangerous for the participant.
- Active drug or alcohol abuse, as assessed in the BBRC-sponsored studies specified above.
- Previous intolerance to PET studies or known hypersensitivity to 18F-RO6958948.
- Being pregnant or breast-feeding.
Key Trial Info
Start Date :
March 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04482660
Start Date
March 29 2021
End Date
December 31 2025
Last Update
May 31 2025
Active Locations (1)
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1
BarcelonaBeta Brain Research Center
Barcelona, Barcelona, Spain, 08005