NCT02685969Recruiting
Brain Characterization of Amyloid Protein and Glucose Metabolism of ALFA Project 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.
Source: ClinicalTrials.gov · Last updated 31 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Study to understand factors related with the preclinical stages of Alzheimer's Disease and investigate markers that predict its progression. Cross-sectional and single arm study performed on a subgroup of individuals recruited in the ALFA project. Study without therapeutic interest for the research participants (440 participants of the ALFA project who have been selected for being cognitively healthy and in their vast majority are direct descendants of patients diagnosed with Alzheimer's Disease). Each study candidate will be selected from the ALFA project (STUDY 45-65 FPM/2012) according to their clinical characteristics, their compliance to selection criteria and their desire to participate in this study. After signing this study's specific informed consent form, the neuropsychological screening and the brain MRI acquisition will be performed. Once all inclusion criteria are checked, the PET scans with 18F-Flutemetamol and 18F-FDG will be performed
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 570 (estimated)
- First submitted
- 15 Feb 2016
- Start date
- 1 Mar 2017
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
- Diseases
- Alzheimer disease
- NCT number
- NCT02685969
What you commit to
- Study type: Observational
- Planned participants: 570
- From 1 Mar 2017 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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).
Who the study is looking for
- 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.
Age in the registry: 45 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Barcelonabeta Brain Research Center Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.