Characterization of cerebral tau aggregates with 18F-RO6958948 PET in the ALFA population

Prior treatment

• 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
• 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

Other illness

• 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
• 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
• Clinically relevant renal or hepatic insufficiency
• Any other clinically important condition that may jeopardize the study or be dangerous for the participant

Other

• Being pregnant or breast-feeding

• 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), the BarcelonaBeta Dementia Prevention Research Clinic study (BBRC-DemPrev-2018) or the βETA-AARC study (β-AARC_BBRC2021)
• Age between 45 and 80 years at the moment of inclusion in the BBRC-sponsored studies specified above
• 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 may 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