Characterization of cerebral amyloid deposition with 18F-Flutemetamol PET and of glucose metabolism with 18F-FDG PET in individuals enrolled in the ALFA project

Barcelonabeta Brain Research Center1 site in 1 country400 target enrollmentJanuary 20, 2025

DrugsALPHA-D-GLUCOPYRANOSE, 2-DEOXY-2-(FLUORO-18F)VIZAMYL 400 MBq/mL solution for injection 18F-FLUDEOXYGLUCOSE FLUTEMETAMOL F-18 Flutemetamol F 18 BARNASCAN 3000 MBq/ml solución inyectable FLUDEOXYGLUCOSE F 18 FLUORODEOXYGLUCOSE F18

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Not specified
Sponsor: Barcelonabeta Brain Research Center
Enrollment: 400
Locations: 1
Primary Endpoint: Participants with a mean cortex activity SUVr (cerebellar cortex) over 1.56 in 18F-Flutemetamol PET will be classified as positive and, otherwise, as negative for cerebral amyloid deposition. Prevalence of positive 18F-Flutemetamol PET will be determined by age, sex, APOE genotype, and familiar history of AD.
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To determine the prevalence and progression of positive 18F-Flutemetamol scans in individuals recruited in the ALFA project

Registry

euclinicaltrials.eu

Start Date

January 20, 2025

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Barcelonabeta Brain Research Center

Responsible Party

Principal Investigator

Oriol Grau

Scientific

Barcelonabeta Brain Research Center

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•To present cognitive impairment at baseline
•Active drug or alcohol abuse
•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
•Previous intolerance to PET studies or known hypersensitivity to 18F-Flutemetamol or 18F-FDG
•Being pregnant or breast-feeding
•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)
•Any contraindication to MRI acquisition, (i.e., metal implants) or phobia to performing the scan as determined by the onsite physician

Outcomes

Primary Outcomes

Participants with a mean cortex activity SUVr (cerebellar cortex) over 1.56 in 18F-Flutemetamol PET will be classified as positive and, otherwise, as negative for cerebral amyloid deposition. Prevalence of positive 18F-Flutemetamol PET will be determined by age, sex, APOE genotype, and familiar history of AD.