Brain Characterization of Amyloid Protein and Glucose Metabolism of ALFA Project Participants
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|ClinicalTrials.gov Identifier: NCT02685969|
Recruitment Status : Active, not recruiting
First Posted : February 19, 2016
Last Update Posted : July 21, 2020
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
|Condition or disease||Intervention/treatment|
|Alzheimer's Disease||Procedure: 18F-Flutemetamol & 18F-FDG|
|Study Type :||Observational|
|Actual Enrollment :||363 participants|
|Official Title:||Characterization of Cerebral Amyloid Deposition With 18F-Flutemetamol PET and of Glucose Metabolism With 18F-FDG PET in Individuals Enrolled in the ALFA Project.|
|Actual Study Start Date :||March 1, 2017|
|Actual Primary Completion Date :||December 20, 2019|
|Estimated Study Completion Date :||December 31, 2020|
18F-Flutemetamol & 18F-FDG PET scans
All study participants will be assessed by PET scan with 18F-Flutemetamol & 18F-FDG PET scans.
Procedure: 18F-Flutemetamol & 18F-FDG
Characterization of cerebral amyloid deposition with 18F-Flutemetamol PET and glucose metabolism 18F-FDG PET.
- Prevalence of a positive 18F-Flutemetamol scan [ Time Frame: Baseline ]To study the prevalence of a positive 18F-Flutemetamol PET scan in a cohort of cognitively healthy, at-risk of developing AD participants.
- Prevalence of the different stages of preclinical AD according to the NIA-AA criteria [ Time Frame: Baseline ]Analysis of amiloid PET acquired
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02685969
|BarcelonaBeta Brain Research Center|
|Barcelona, Catalunya, Spain, 08005|
|Principal Investigator:||Jose Luis Molinuevo, MD, PhD||Scientific Director|