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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02685969
Recruitment Status : Active, not recruiting
First Posted : February 19, 2016
Last Update Posted : June 10, 2021
Sponsor:
Collaborators:
Hospital Clinic of Barcelona
General Electric
Information provided by (Responsible Party):
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Study Description
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Brief Summary:

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

Detailed Description:
18F-Flutemetamol scans will be categorized as either positive or negative according to the standardized uptake value ratio (a quantitative measurement based on a ratio of mean target cortex activity divided by that in a cerebellar reference region). Participants with a SUVr over 1.56 will be classified as positive and, otherwise, as negative.
Study Design
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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, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Prevalence of the different stages of preclinical AD according to the NIA-AA criteria [ Time Frame: Baseline ]
    Analysis of amiloid PET acquired


Eligibility Criteria
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Information from the National Library of Medicine

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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
Study 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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Spain
BarcelonaBeta Brain Research Center
Barcelona, Catalunya, Spain, 08005
Sponsors and Collaborators
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Hospital Clinic of Barcelona
General Electric
Investigators
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Principal Investigator: Jose Luis Molinuevo, MD, PhD Scientific Director
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: June 10, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation:
Prevention
Positron Emission Tomography
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
 Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Flutemetamol
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action