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Characterization of cerebral tau aggregates with 18F-RO6958948 PET in the ALFA population
EU CTIS ID: 2024-516209-21-00
What this study is testing
Characterize tau tracer retention as a function of amyloid levels transversally and longitudinally.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
- Being pregnant or breast-feeding
- 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
See the full eligibility criteria
Who can join
- 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
What rules you out
- 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
- Being pregnant or breast-feeding
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.