NCT02685969 · RECRUITING
Brain Characterization of Amyloid Protein and Glucose Metabolism of ALFA Project Participants
This study uses two types of PET brain scans to measure amyloid protein buildup and glucose metabolism in cognitively healthy adults who are mostly children of Alzheimer's patients. It is observational, not a treatment — no drug is being tested. Researchers want to understand what early brain changes look like before any symptoms appear. Phase is unspecified because this is a imaging and biomarker study, not a drug trial.
You may qualify if
- 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.
You're excluded if
- 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-05-31