Characterization of cerebral amyloid deposition with 18F-Flutemetamol PET and of glucose metabolism with 18F-FDG PET in individuals enrolled in the ALFA project
Key facts
- Where
- Barcelona, SpanyolországSee the site
- Phase
- 4. fázis
Where in Spanyolország
- Barcelonabeta Brain Research CenterBarcelona, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Barcelonabeta Brain Research Center
- Trial code
- EU 2024-519961-23-00
- Record updated
- 2026. május 13.
- Original description
To determine the prevalence and progression of positive 18F-Flutemetamol scans in individuals recruited in the ALFA projectRead full original descriptionShow less
To determine the prevalence and progression of positive 18F-Flutemetamol scans in individuals recruited in the ALFA project
Inclusion: To sign the study informed consent form approved by the corresponding authorities; Men and women enrolled in the STUDY 45-65 FPM/2012; Participants with a cerebral MRI (magnetic resonance imaging) not suggestive of radiological incidental findings constituting an exclusion criterion; Cognition within psychometric normal ranges: MMSE (Mini Mental State Examination ≥26 and Verbal Semantic Fluency (animals) ≥12) at baseline; Score of 0 in the CDR scale (Clinical Dementia Rating) at baseline; Good knowledge of Spanish or Catalan and being literate; Female participants should be post-menopausal or present a negative pregnancy test at the moment of PET realization.
Exclusion: Active drug or alcohol abuse; Previous intolerance to PET studies or known hypersensitivity to 18F-Flutemetamol or 18F-FDG; Any contraindication to MRI acquisition, (i.e., metal implants) or phobia to performing the scan as determined by the onsite physician; 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; To present cognitive impairment at baseline; Presence of a pacemaker, aneurysm graft, artificial heart valves, auditory implants, cerebral shunts, metal fragments, or strange objects in the eyes, skin, or body that may contraindicate magnetic resonance imaging; 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; Individuals with visual and/or hearing impairment; History of encephalitis, ictus, or seizures excluding feverish convulsions during childhood; Severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumour (metastasis/brain cancer) as verified by magnetic resonance imaging (MRI); Clinically relevant renal or hepatic insufficiency; Any other clinically significant condition that may jeopardize the study or be dangerous for the participant; Being pregnant or breast-feeding.