Brain Characterization of Amyloid Protein and Glucose Metabolism of ALFA Project Participants

18F-Flutemetamol scans will be categorized as either positive or negative according to the standardized uptake value ratio (a quantitative measurement based on a ratio of mean target cortex activity divided by that in a cerebellar reference region). Participants with a SUVr over 1.56 will be classified as positive and, otherwise, as negative.

Inclusion criteria

• To sign the study informed consent form approved by the corresponding authorities.
• Men and women enrolled in the ALFA project (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 psychometrically normal ranges: MMSE (Mini Mental State Examination ≥26 and Semantic Fluency (animals) ≥12.
• Score of 0 in the CDR scale (Clinical Dementia Rating).
• 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.

Exclusion criteria

• Present cognitive impairment.
• Presence of clinically relevant psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV-TR) criteria: major depressive disorder, generalized anxiety disorder, schizophrenia or 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 tumor (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.