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Active, not recruitingNCT02685969Updated Jan 12, 2024

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

An observational study in Alzheimer's Disease, sponsored by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation. Active, not recruiting at 1 site in Spain. Open to participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-12.

Sponsored by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Cross-sectional
Enrollment
363
Ages
45 Years to 75 Years
Sex
All
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Study 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

Read the 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.

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Conditions studied

  • Alzheimer's Disease

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Keywords

  • Prevention
  • Positron Emission Tomography
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In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 363 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation is the lead sponsor of 22 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years to 75 Years
Sexes eligible
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.

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

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.
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Study design

Observational model
Case-crossover
Time perspective
Cross-sectional
Enrollment
363 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • Procedure18F-Flutemetamol & 18F-FDG

    Characterization of cerebral amyloid deposition with 18F-Flutemetamol PET and glucose metabolism 18F-FDG PET.

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What researchers measure

Primary outcomes

  1. Prevalence of a positive 18F-Flutemetamol scan

    To study the prevalence of a positive 18F-Flutemetamol PET scan in a cohort of cognitively healthy, at-risk of developing AD participants.

    Time frame: Baseline

Secondary outcomes

  1. Prevalence of the different stages of preclinical AD according to the NIA-AA criteria

    Analysis of amiloid PET acquired

    Time frame: Baseline

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Study locations

1 site
  • BarcelonaBeta Brain Research Center
    Barcelona, Catalunya 08005, Spain
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References and documents

Publications

  • Grau-Rivera O, Navalpotro-Gomez I, Sanchez-Benavides G, Suarez-Calvet M, Mila-Aloma M, Arenaza-Urquijo EM, Salvado G, Sala-Vila A, Shekari M, Gonzalez-de-Echavarri JM, Minguillon C, Ninerola-Baizan A, Perissinotti A, Simon M, Kollmorgen G, Zetterberg H, Blennow K, Gispert JD, Molinuevo JL; ALFA Study. Association of weight change with cerebrospinal fluid biomarkers and amyloid positron emission tomography in preclinical Alzheimer's disease. Alzheimers Res Ther. 2021 Feb 17;13(1):46. doi: 10.1186/s13195-021-00781-z. PubMed 33597012 ↗
  • Salvado G, Molinuevo JL, Brugulat-Serrat A, Falcon C, Grau-Rivera O, Suarez-Calvet M, Pavia J, Ninerola-Baizan A, Perissinotti A, Lomena F, Minguillon C, Fauria K, Zetterberg H, Blennow K, Gispert JD; Alzheimer's Disease Neuroimaging Initiative, for the ALFA Study. Centiloid cut-off values for optimal agreement between PET and CSF core AD biomarkers. Alzheimers Res Ther. 2019 Mar 21;11(1):27. doi: 10.1186/s13195-019-0478-z. PubMed 30902090 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02685969
Lead sponsor
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Collaborators
Hospital Clinic of Barcelona, General Electric
Responsible party
Sponsor
First posted
Feb 19, 2016
Start date
Mar 1, 2017
Primary completion
Dec 20, 2019
Completion
Dec 31, 2024 (estimated)
Last update
Jan 12, 2024

Study contacts

Jose Luis Molinuevo, MD, PhD
principal investigator · Scientific Director

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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