Evidence map›Paper›PMID 33773598›Full record

ArticleAlzheimer's research & therapy2021

Early detection of amyloid load using

Santiago Bullich, Núria Roé-Vellvé, Marta Marquié, Susan M Landau, Henryk Barthel, Victor L Villemagne, Ángela Sanabria, Juan Pablo Tartari, Oscar Sotolongo-Grau, Vincent Doré and 11 more

4 registry-linked trialsAbstract read
In one paragraph

Article in Alzheimer's research & therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 41 papers.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00750282 phase2completednot on this map

An Open-label, Non-randomized, Multi-center Study to Optimize Image Assessment and Evaluate the Efficacy and Safety of BAY 94-9172 (ZK 6013443) Positron Emission Tomography (PET) for Detection/Exclusion of Cerebral Amyloid Beta in Patients With Probable Alzheimer's Disease Compared to Healthy Volunteers

TypeinterventionalSponsorLantheus Biosciences Ltd.Ran2008 to 2010Enrolled422ConditionsAlzheimer Disease, Amyloid Beta-ProteinArmsFlorbetaben (BAY94-9172)
NCT00928304 phase2completednot on this map

An Open-Label, Non-Randomized Study to Evaluate the Efficacy and Safety of BAY94-9172 (ZK 6013443) Positron Emission Tomography (PET) for Detection of Cerebral ß-Amyloid in Individuals With Down Syndrome Compared to Individuals Without Down Syndrome

TypeinterventionalSponsorLantheus Biosciences Ltd.Ran2009 to 2011Enrolled109ConditionsDown Syndrome, Amyloid Beta-proteinArmsFlorbetaben (BAY94-9172)
NCT01138111 phase1completednot on this map

ß-amyloid Imaging With BAY94-9172 Positron Emission Tomography for Early Detection of Alzheimer's Disease in Patients With Mild Cognitive Impairment

TypeinterventionalSponsorLantheus Biosciences Ltd.Ran2008 to 2011Enrolled45ConditionsAlzheimer Disease, Amyloid Beta-ProteinArmsFlorbetaben (BAY94-9172)
NCT02854033 completednot on this map

Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3)

TypeobservationalSponsorUniversity of Southern CaliforniaRan2016 to 2024Enrolled1,141ConditionsMild Cognitive Impairment (MCI), Alzheimer's Disease (AD)
3 · Its place in the literature

Who cites it

41 citing papers in PubMed.

  1. Evaluation of tau deposition usingAlzheimer's research & therapy · 2022
    Trial
  2. Article
  3. Article
  4. In vivo mapping of cortical amyloid beta-myelin coupling in preclinical Alzheimer's disease.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026
    Article
  5. Article
  6. Brain Amyloid Burden Mapping Using MR Fingerprinting Aided by Deep Learning.Magnetic resonance in medical sciences : MRMS : an official journal of Japan Society of Magnetic Resonance in Medicine · 2026
    Article
  7. Plasma p-tau217 and Aβ42/40 as markers of Aβ pathology in the Lewy body continuum.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025
    Article
  8. Article
  9. Evaluation of early-phaseJournal of Alzheimer's disease : JAD · 2025
    Article
  10. Article
  11. Article
  12. Observational
  13. Review
  14. Review
  15. Voxel-based evaluation for [Quantitative imaging in medicine and surgery · 2024
    Article
  16. Centiloid recommendations for clinical context-of-use from the AMYPAD consortium.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2024
    Review
  17. Head-to-head comparison of tau PET tracers [Alzheimer's research & therapy · 2024
    Article
  18. Article
  19. Cognitively defined Alzheimer's dementia subgroups have distinct atrophy patterns.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2024
    Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors.

Santiago Bullich *Life Molecular Imaging GmbH, Tegeler Str. 6-7, 13353, Berlin, Germany. s.bullich@life-mi.com.ORCID 0000-0001-5669-269X
Núria Roé-Vellvé *Life Molecular Imaging GmbH, Tegeler Str. 6-7, 13353, Berlin, Germany.
Marta MarquiéFundació ACE Institut Català de Neurociències Aplicades, Research Center and Memory Unit - Universitat Internacional de Catalunya (UIC), Barcelona, Spain.
Susan M LandauHelen Wills Neuroscience Institute, University of California, Berkeley and Lawrence Berkeley National Laboratory, Berkeley, CA, USA.
Henryk BarthelDepartment of Nuclear Medicine, University Hospital Leipzig, Leipzig, Germany.
Victor L VillemagneDepartment of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.
Ángela SanabriaFundació ACE Institut Català de Neurociències Aplicades, Research Center and Memory Unit - Universitat Internacional de Catalunya (UIC), Barcelona, Spain.
Juan Pablo TartariFundació ACE Institut Català de Neurociències Aplicades, Research Center and Memory Unit - Universitat Internacional de Catalunya (UIC), Barcelona, Spain.
Oscar Sotolongo-GrauFundació ACE Institut Català de Neurociències Aplicades, Research Center and Memory Unit - Universitat Internacional de Catalunya (UIC), Barcelona, Spain.
Vincent DoréDepartments of Medicine and Molecular Imaging, University of Melbourne, Austin Health, Melbourne, Victoria, Australia.
Norman KoglinLife Molecular Imaging GmbH, Tegeler Str. 6-7, 13353, Berlin, Germany.
Andre MüllerLife Molecular Imaging GmbH, Tegeler Str. 6-7, 13353, Berlin, Germany.
Audrey PerrotinLife Molecular Imaging GmbH, Tegeler Str. 6-7, 13353, Berlin, Germany.
Aleksandar JovalekicLife Molecular Imaging GmbH, Tegeler Str. 6-7, 13353, Berlin, Germany.
Susan De SantiLife Molecular Imaging Inc, Boston, MA, USA.
Lluís TárragaFundació ACE Institut Català de Neurociències Aplicades, Research Center and Memory Unit - Universitat Internacional de Catalunya (UIC), Barcelona, Spain.
Andrew W StephensLife Molecular Imaging GmbH, Tegeler Str. 6-7, 13353, Berlin, Germany.
Christopher C RoweDepartments of Medicine and Molecular Imaging, University of Melbourne, Austin Health, Melbourne, Victoria, Australia.
Osama SabriDepartment of Nuclear Medicine, University Hospital Leipzig, Leipzig, Germany.
John P SeibylInvicro, New Haven, CT, USA.
Mercè BoadaFundació ACE Institut Català de Neurociències Aplicades, Research Center and Memory Unit - Universitat Internacional de Catalunya (UIC), Barcelona, Spain.

Funding

Alzheimer's Disease Neuroimaging Initiative - SupplementU01AG024904 · NIA · NORTHERN CALIFORNIA INSTITUTE RES &EDUC · PI WEINER, MICHAEL W · 2004 to 2015
$121.0M
NIA NIH HHS U01 AG024904
6 · The paper itself

Abstract

backgroundA low amount and extent of Aβ deposition at early stages of Alzheimer's disease (AD) may limit the use of previously developed pathology-proven composite SUVR cutoffs. This study aims to characterize the population with earliest abnormal Aβ accumulation using

methodsThe study population consisted of 686 subjects (n = 287 (cognitively normal healthy controls), n = 166 (subjects with subjective cognitive decline (SCD)), n = 129 (subjects with MCI), and n = 101 (subjects with AD dementia)). Three categories in the Aβ-deposition continuum were defined based on the developed SUVR cutoffs: Aβ-negative subjects, subjects with early Aβ deposition ("gray zone"), and subjects with established Aβ pathology.

resultsSUVR using the whole cerebellum as the reference region and centiloid (CL) cutoffs for early and established amyloid pathology were 1.10 (13.5 CL) and 1.24 (35.7 CL), respectively. Cingulate cortices and precuneus, frontal, and inferior lateral temporal cortices were the regions showing the initial pathological tracer retention. Subjects in the "gray zone" or with established Aβ pathology accumulated more amyloid over time than Aβ-negative subjects. After a 4-year clinical follow-up, none of the Aβ-negative or the gray zone subjects progressed to AD dementia while 91% of the MCI subjects with established Aβ pathology progressed. Tau deposition was infrequent in those subjects without established Aβ pathology.

conclusionsThis study supports the utility of using two cutoffs for amyloid PET abnormality defining a "gray zone": a lower cutoff of 13.5 CL indicating emerging Aβ pathology and a higher cutoff of 35.7 CL where amyloid burden levels correspond to established neuropathology findings. These cutoffs define a subset of subjects characterized by pre-AD dementia levels of amyloid burden that precede other biomarkers such as tau deposition or clinical symptoms and accelerated amyloid accumulation. The determination of different amyloid loads, particularly low amyloid levels, is useful in determining who will eventually progress to dementia. Quantitation of amyloid provides a sensitive measure in these low-load cases and may help to identify a group of subjects most likely to benefit from intervention.

trial registrationData used in this manuscript belong to clinical trials registered in ClinicalTrials.gov ( NCT00928304 , NCT00750282 , NCT01138111 , NCT02854033 ) and EudraCT (2014-000798-38).

Indexed as

Alzheimer DiseaseCognitive DysfunctionAmyloid beta-PeptidesAniline CompoundsHumansPositron-Emission TomographyStilbenes4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbeneAmyloid beta-PeptidesAniline CompoundsStilbenesAlzheimer’s diseaseAmyloid-betaFlorbetabenMild cognitive impairmentPETSubjective memory complainers

Identifiers

PMID33773598
PMCPMC8005243

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.