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Characterization of cerebral amyloid deposition with 18F-Flutemetamol PET and of glucose metabolism with 18F-FDG PET in individuals enrolled in the ALFA project
EU CTIS ID: 2024-519961-23-00
What this study is testing
To determine the prevalence and progression of positive 18F-Flutemetamol scans in individuals recruited in the ALFA project
- Therapeutic use (Phase IV)
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 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
You likely can't join if
- To present cognitive impairment at baseline
- Active drug or alcohol abuse
- 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
- Previous intolerance to PET studies or known hypersensitivity to 18F-Flutemetamol or 18F-FDG
- Being pregnant or breast-feeding
- 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
See the full eligibility criteria
- 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
- To present cognitive impairment at baseline
- Active drug or alcohol abuse
- 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
- Previous intolerance to PET studies or known hypersensitivity to 18F-Flutemetamol or 18F-FDG
- Being pregnant or breast-feeding
- 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)
- 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
- Clinically relevant renal or hepatic insufficiency
- Any other clinically significant condition that may jeopardize the study or be dangerous for the participant
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
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.