Brain Characterization of Amyloid Protein and Glucose Metabolism of ALFA Project Participants

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45-75
SponsorBarcelonabeta Brain Research Center, Pasqual Maragall Foundation

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

A total of 440 participants enrolled in the ALFA project (STUDY 45-65 FPM/2012) will be selected and physiologically characterized with 18F-Flutemetamol and 18F-FDG PET scans.

Trial design

Design model

Case-crossover

Time perspective

Cross-sectional

Treatments tested in this trial

  • 18F-Flutemetamol & 18F-FDG

    Procedure/Surgery

    Characterization of cerebral amyloid deposition with 18F-Flutemetamol PET and glucose metabolism 18F-FDG PET.

Treatment groups

570 Participants
are divided into 1 treatment group
Group A: 18F-Flutemetamol & 18F-FDG PET scans1 intervention

Trial outcomes

Primary outcomes

1

Prevalence of a positive 18F-Flutemetamol scan

To study the prevalence of a positive 18F-Flutemetamol PET scan in a cohort of cognitively healthy, at-risk of developing AD participants.

Time frame
Baseline

Secondary outcomes

1

Prevalence of the different stages of preclinical AD according to the NIA-AA criteria

Analysis of amiloid PET acquired

Time frame
Baseline

Other outcomes

Sponsors and contacts

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Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Lead sponsor

Hospital Clinic of Barcelona

Collaborator

General Electric

Collaborator