Brain amyloid and glucose metabolism characterization in ALFA participants
Characterization of Cerebral Amyloid Deposition With 18F-Flutemetamol PET and of Glucose Metabolism With 18F-FDG PET in Individuals Enrolled in the ALFA Project.
This study will use amyloid PET (18F‑Flutemetamol) and FDG PET scans to see if brain amyloid levels and glucose metabolism patterns are present in cognitively healthy middle-aged ALFA participants, many of whom are descendants of people with Alzheimer's.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 570 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | All |
| Sponsor | Barcelonabeta Brain Research Center, Pasqual Maragall Foundation Academic / other |
| Locations | 1 site (Barcelona, Catalonia) |
| Trial ID | NCT02685969 on ClinicalTrials.gov |
What this trial studies
This is a cross-sectional, single-arm imaging study in a subgroup (about 440) of cognitively normal participants from the ALFA cohort who are largely first-degree descendants of Alzheimer’s patients. After informed consent, participants complete neuropsychological screening and a brain MRI to confirm eligibility, then undergo PET scans with 18F‑Flutemetamol (amyloid) and 18F‑FDG (glucose metabolism). Amyloid scans are quantified using standardized uptake value ratios (SUVr) with a cutoff of 1.56 to classify amyloid positivity. The study aims to map preclinical amyloid deposition and metabolic patterns that may help predict future progression.
Who should consider this trial
Good fit: Ideal participants are cognitively normal adults from the ALFA project (approximately ages 45–65) with MMSE≥26, CDR=0, intact semantic fluency, a clean screening MRI, literacy and, for women, post-menopausal status or a negative pregnancy test.
Not a fit: People with current cognitive impairment, major psychiatric disorders, MRI findings that exclude participation, or who are not enrolled in the ALFA cohort are unlikely to benefit from this observational imaging work.
Why it matters
Potential benefit: If successful, the results could help identify early brain changes that predict Alzheimer's risk and guide earlier monitoring or prevention studies.
How similar studies have performed: Previous PET studies have shown that amyloid PET and FDG PET can detect preclinical amyloid and metabolic changes, so this approach builds on well-established methods applied to a family-risk ALFA cohort.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Barcelona, Catalonia
- BarcelonaBeta Brain Research Center — Barcelona, Catalonia, Spain (Recruiting)
Study contacts
- Principal investigator: Jose Luis Molinuevo, MD, PhD — Scientific Director
- Study coordinator: Karine Fauria, PhD
- Email: kfauria@fpmaragall.org
- Phone: 933160990
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.