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

January 11, 2024 updated by: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Characterization of Cerebral Amyloid Deposition With 18F-Flutemetamol PET and of Glucose Metabolism With 18F-FDG PET in Individuals Enrolled in the ALFA Project.

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

363

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Catalunya
      • Barcelona, Catalunya, Spain, 08005
        • BarcelonaBeta Brain Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of the different stages of preclinical AD according to the NIA-AA criteria
Time Frame: Baseline
Analysis of amiloid PET acquired
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Collaborators

Hospital Clinic of Barcelona
General Electric

Investigators

  • Principal Investigator: Jose Luis Molinuevo, MD, PhD, Scientific Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

December 20, 2019

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

February 15, 2016

First Submitted That Met QC Criteria

February 15, 2016

First Posted (Estimated)

February 19, 2016

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PET FLUTEMETAMOL-FDG/BBRC2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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