2-(6-[18F]FLUORO-PYRIDIN-3-YL)-9H-DIPYRIDO[2,3-B:3',4'-D]PYRROLE for Alzheimer's disease

Inclusion criteria

• {"criterion_text":"- To sign the study informed consent form approved by the corresponding authorities\n- 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)\n- Age between 45 and 80 years at the moment of inclusion in the BBRC-sponsored studies specified above\n- Participants with an available cerebral MRI within the last 12 months not suggestive of radiological incidental findings constituting an exclusion criterion\n- 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\n- Known AB and tau status\n- Good knowledge of the language and being literate\n- Female participants should be post-menopausal or present a negative pregnancy test at the moment of PET acquisition"}

Exclusion criteria

• {"criterion_text":"- 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\n- Being pregnant or breast-feeding\n- Visual and/or hearing impairment\n- History of encephalitis, ictus or seizures excluding feverish convulsions during childhood, as assessed in the BBRC-sponsored studies specified above\n- Severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumour (metastasis/brain cancer) as verified by MRI\n- 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\n- Clinically relevant renal or hepatic insufficiency\n- Any other clinically important condition that may jeopardize the study or be dangerous for the participant\n- Active drug or alcohol abuse, as assessed in the BBRC-sponsored studies specified above\n- Previous intolerance to PET studies or known hypersensitivity to 18F-RO6958948"}

Primary endpoints

• {"endpoint_text":"- Global and regional retention rate of 18F-RO6958948","definition_or_measurement_approach":""}

Methods

• Recruitment from participants of BBRC-sponsored studies and cohorts including: ALFA project (STUDY 45-65 FPM/2012), ALFA+ cohort study (ALFA - FPM - 0311), ALFA cognition study (ALFAcognition/BBRC2017), BarcelonaBeta Dementia Prevention Research Clinic study (BBRC-DemPrev-2018), and βETA-AARC study (β-AARC_BBRC2021).

Spain

Earliest CTIS Part Ii Submission Date

05-11-2024

Latest Decision Or Authorization Date

31-03-2026

Processing Time Days

511

Number Of Sites

1

Number Of Participants

200

Primary sponsor

Full Name

Barcelonabeta Brain Research Center

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain

Third parties

• {"country":"","full_name":"F. HOFFMANN-LA ROCHE LTD","duties_or_roles":"Source of monetary support","organisation_type":""}