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Clinical Trials in Spain / NCT04482660
Enrolling by invitation Not applicable

Characterization of Cerebral Tau Aggregates With 18F-RO6958948 PET in the ALFA Population

NCT04482660 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2021-03-29
Last updated
2025-05-31

Condition(s) studied

HealthyMild Cognitive Impairment

Investigational drug(s) / intervention(s)

Positron emission tomography with 18F-RO6958948

Positron emission tomography with 18F-RO6958948: tau PET ()

Study summary

This study will characterize tau tracer retention by Positron Emission Tomography (PET) as a function of amyloid levels transversally and longitudinally.

Eligibility

Sex
ALL
Min age
45 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 1. To sign the study informed consent form approved by the corresponding authorities. 2. 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). 3. Participants with an available cerebral MRI within the last 12 months not suggestive of radiological incidental findings constituting an exclusion criterion. 4. 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. 5. Known AB and tau status. 6. Good knowledge of the language and being literate. 7. Female participants should be post-menopausal or present a negative pregnancy test at the moment of PET acquisition. Exclusion Criteria: 1. 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. 2. Participants with visual and/or hearing impairment. 3. History of encephalitis, ictus or seizures excluding feverish convulsions during childhood, as assessed in the BBRC-sponsored studies specified above. 4. Severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumour (metastasis/brain cancer) as verified by MRI. 5. 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. 6. Clinically relevant renal or hepatic insufficiency. 7. Any other clinically important condition that may jeopardize the study or be dangerous for the participant. 8. Active drug or alcohol abuse, as assessed in the BBRC-sponsored studies specified above. 9. Previous intolerance to PET studies or known hypersensitivity to 18F-RO6958948. 10. Being pregnant or breast-feeding.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
BarcelonaBeta Brain Research Center Barcelona Barcelona

More Barcelonabeta Brain Research Center, Pasqual Maragall Foundation trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04482660 on ClinicalTrials.gov ↗ ← All trials in Spain