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

Phase 4

Not yet recruiting

• Conditions: Alzheimer's Disease

• Registration Number: 2024-519961-23-00
• Lead Sponsor: Barcelonabeta Brain Research Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Posted: 2025-01-20
• Last Update Posted: 2025-01-30

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 400

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

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

Clinically relevant renal or hepatic insufficiency

Any other clinically significant condition that may jeopardize the study or be dangerous for the participant

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.		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.

Trial Locations

Locations (1)

Barcelonabeta Brain Research Center; 🇪🇸 Barcelona, Spain

Barcelonabeta Brain Research Center

🇪🇸Barcelona, Spain

Oriol Grau

Site contact

933160990

regulatory@barcelonabeta.org