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

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 design

Treatments tested in this trial

  • 18F-Flutemetamol & 18F-FDG

Treatment groups

570 Participants
are divided into 1 treatment group

Sponsors and collaborators

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Lead sponsor

Hospital Clinic of Barcelona

Collaborator

General Electric

Collaborator