2024-519961-23-00RecruitingPhase 4
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: EU CTIS (euclinicaltrials.eu) · Last updated 13 May 2026
Brief summary (registry, in English)
To determine the prevalence and progression of positive 18F-Flutemetamol scans in individuals recruited in the ALFA project
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 10 Jan 2025
- Start date
- 25 Jan 2025
- Lead sponsor
- Barcelonabeta Brain Research Center
- Diseases
- Alzheimer disease
- EU CT number
- 2024-519961-23-00
- EudraCT number
- 2015-004474-15
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 400
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men and women already in the ALFA project (study 45-65 FPM/2012) who have normal thinking and memory scores. They will have brain PET scans to look for amyloid and measure glucose use.
- Age
- Records list a minimum age of 18 years; the study is for people enrolled in study 45-65 FPM/2012.
- Sex
- Men and women can join.
- Disease stage
- Normal thinking and memory at the start: MMSE 26 or higher, Verbal Semantic Fluency (animals) 12 or higher, and a score of 0 on the CDR scale.
- Earlier treatment
- Cannot have taken part in a study of an investigational medicine within 30 days before screening, or have had a radiopharmaceutical within 10 radioactive half-lives before the study drug.
Main reasons for not taking part
- Memory or thinking problems at the start
- Active drug or alcohol abuse
- Pregnant or breast-feeding
- Major psychiatric disorders such as major depression, schizophrenia or bipolar disorder
- Cannot have an MRI scan (for example a pacemaker or metal implants)
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active drug or alcohol abuse
- Previous intolerance to PET studies or known hypersensitivity to 18F-Flutemetamol or 18F-FDG
- 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
- To present cognitive impairment at baseline
- 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
- 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
- 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 tumour (metastasis/brain cancer) as verified by magnetic resonance imaging (MRI)
- Clinically relevant renal or hepatic insufficiency
- Any other clinically significant condition that may jeopardize the study or be dangerous for the participant
Other
- Being pregnant or breast-feeding
Who the study is looking for
- To sign the study informed consent form approved by the corresponding authorities
- Men and women enrolled in the 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 psychometric normal ranges: MMSE (Mini Mental State Examination ≥26 and Verbal Semantic Fluency (animals) ≥12) at baseline
- Score of 0 in the CDR scale (Clinical Dementia Rating) at baseline
- Good knowledge of Spanish or Catalan and being literate
- Female participants should be post-menopausal or present a negative pregnancy test at the moment of PET realization
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Barcelonabeta Brain Research Center | Barcelona | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.