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
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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 |
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Alzheimer's Disease | Procedure: 18F-Flutemetamol & 18F-FDG |
Study Type : | Observational |
Actual Enrollment : | 363 participants |
Observational Model: | Case-Crossover |
Time Perspective: | Cross-Sectional |
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 |

Group/Cohort | Intervention/treatment |
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18F-Flutemetamol & 18F-FDG PET scans
All study participants will be assessed by PET scan with 18F-Flutemetamol & 18F-FDG PET scans.
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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

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Ages Eligible for Study: | 45 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
- Score of 0 in the CDR scale (Clinical Dementia Rating).
- Good knowledge of the language and being literate.
- Female participants should be post-menopausal or present a negative pregnancy test at the moment of PET acquisition.
Exclusion Criteria:
- 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.
- Severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumor (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.

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
Spain | |
BarcelonaBeta Brain Research Center | |
Barcelona, Catalunya, Spain, 08005 |
Principal Investigator: | Jose Luis Molinuevo, MD, PhD | Scientific Director |
Responsible Party: | Barcelonabeta Brain Research Center, Pasqual Maragall Foundation |
ClinicalTrials.gov Identifier: | NCT02685969 |
Other Study ID Numbers: |
PET FLUTEMETAMOL-FDG/BBRC2015 |
First Posted: | February 19, 2016 Key Record Dates |
Last Update Posted: | July 21, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Prevention Positron Emission Tomography |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases |
Neurocognitive Disorders Mental Disorders Fluorodeoxyglucose F18 Flutemetamol Radiopharmaceuticals Molecular Mechanisms of Pharmacological Action |