Fludeoxyglucose (18F) for Alzheimer's disease

Inclusion criteria

• {"criterion_text":"- To sign the study informed consent form approved by the corresponding authorities"}
• {"criterion_text":"- Men and women enrolled in the STUDY 45-65 FPM/2012"}
• {"criterion_text":"- Participants with a cerebral MRI (magnetic resonance imaging) not suggestive of radiological incidental findings constituting an exclusion criterion"}
• {"criterion_text":"- Cognition within psychometric normal ranges: MMSE (Mini Mental State Examination ≥26 and Verbal Semantic Fluency (animals) ≥12) at baseline"}
• {"criterion_text":"- Score of 0 in the CDR scale (Clinical Dementia Rating) at baseline"}
• {"criterion_text":"- Good knowledge of Spanish or Catalan and being literate"}
• {"criterion_text":"- Female participants should be post-menopausal or present a negative pregnancy test at the moment of PET realization"}

Exclusion criteria

• {"criterion_text":"- To present cognitive impairment at baseline"}
• {"criterion_text":"- Active drug or alcohol abuse"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Previous intolerance to PET studies or known hypersensitivity to 18F-Flutemetamol or 18F-FDG"}
• {"criterion_text":"- Being pregnant or breast-feeding"}
• {"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"}
• {"criterion_text":"- Individuals with visual and/or hearing impairment"}
• {"criterion_text":"- History of encephalitis, ictus, or seizures excluding feverish convulsions during childhood"}
• {"criterion_text":"- Severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumour (metastasis/brain cancer) as verified by magnetic resonance imaging (MRI)"}
• {"criterion_text":"- Any contraindication to MRI acquisition, (i.e., metal implants) or phobia to performing the scan as determined by the onsite physician"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Clinically relevant renal or hepatic insufficiency"}
• {"criterion_text":"- Any other clinically significant condition that may jeopardize the study or be dangerous for the participant"}

Primary endpoints

• {"endpoint_text":"- Participants with a mean cortex activity SUVr (cerebellar cortex) over 1.56 in 18F-Flutemetamol PET will be classified as positive and, otherwise, as negative for cerebral amyloid deposition. Prevalence of positive 18F-Flutemetamol PET will be determined by age, sex, APOE genotype, and familiar history of AD.","definition_or_measurement_approach":"Classification based on mean cortex activity SUVr using cerebellar cortex reference; threshold >1.56 = positive for cerebral amyloid deposition. Prevalence stratified/determined by age, sex, APOE genotype, and family history of Alzheimer's disease."}

Spain

Earliest CTIS Part Ii Submission Date

09-01-2025

Latest Decision Or Authorization Date

13-05-2026

Processing Time Days

489

Number Of Sites

1

Number Of Participants

400

Primary sponsor

Full Name

Barcelonabeta Brain Research Center

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain

Third parties

• {"country":"","full_name":"General Electric (GE Healthcare Bio-Sciences, SAU)","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"Spain","full_name":"ADVANCED ACCELERATOR APPLICATIONS IBÉRICA, S.L.U","duties_or_roles":"","organisation_type":""}
• {"country":"Liechtenstein","full_name":"GE HEALTHCARE AS","duties_or_roles":"","organisation_type":""}