AMYPAD Diagnostic and Patient Management Study: Rationale and design

Giovanni B Frisoni¹, Frederik Barkhof², Daniele Altomare³, Johannes Berkhof⁴, Marina Boccardi⁵, Elisa Canzoneri⁶, Lyduine Collij⁷, Alexander Drzezga⁸, Gill Farrar⁹, Valentina Garibotto¹⁰, Rossella Gismondi¹¹, Juan-Domingo Gispert¹², Frank Jessen¹³, Miia Kivipelto¹⁴, Isadora Lopes Alves⁷, José Luis Molinuevo¹⁵, Agneta Nordberg¹⁶, Pierre Payoux¹⁷, Craig Ritchie¹⁸, Irina Savicheva¹⁹, Philip Scheltens²⁰, Mark E Schmidt²¹, Jonathan M Schott²², Andrew Stephens²³, Bart van Berckel⁷, Bruno Vellas²⁴, Zuzana Walker²⁵, Nicola Raffa²⁶

Affiliations

¹ Laboratory of Neuroimaging of Aging (LANVIE), University of Geneva, Geneva, Switzerland; Memory Clinic, University Hospital of Geneva, Geneva, Switzerland; Laboratory of Alzheimer's Neuroimaging and Epidemiology (LANE), Saint John of God Clinical Research Centre, Brescia, Italy. Electronic address: giovanni.frisoni@unige.ch.
² Department of Radiology and Nuclear Medicine, Amsterdam Neuroscience, VU University Medical Center, Amsterdam, the Netherlands; Institutes of Neurology and Healthcare Engineering, UCL, London, United Kingdom.
³ Laboratory of Alzheimer's Neuroimaging and Epidemiology (LANE), Saint John of God Clinical Research Centre, Brescia, Italy; Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy.
⁴ Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, the Netherlands.
⁵ Laboratory of Neuroimaging of Aging (LANVIE), University of Geneva, Geneva, Switzerland; Laboratory of Alzheimer's Neuroimaging and Epidemiology (LANE), Saint John of God Clinical Research Centre, Brescia, Italy.
⁶ Laboratory of Neuroimaging of Aging (LANVIE), University of Geneva, Geneva, Switzerland.
⁷ Department of Radiology and Nuclear Medicine, Amsterdam Neuroscience, VU University Medical Center, Amsterdam, the Netherlands.
⁸ Department of Nuclear Medicine, University Hospital of Cologne, University of Cologne and German Center for Neurodegenerative Diseases (DZNE), Germany.
⁹ Life Sciences, GE Healthcare, Amersham, Buckinghamshire, United Kingdom.
¹⁰ Division of Nuclear Medicine and Molecular Imaging, Department of Medical Imaging, University Hospitals of Geneva, Geneva, Switzerland; NIMTlab, Faculty of Medicine, Geneva University, Geneva, Switzerland.
¹¹ Piramal Imaging, Medical Affairs, Berlin, Germany.
¹² Barcelonaβeta Brain Research Center, Pasqual Maragall Foundation, Barcelona, Spain; Centro de Investigación Biomédica en Red de Bioingeniería, Biomateriales y Nanomedicina (CIBER-BBN), Madrid, Spain.
¹³ Department of Psychiatry and Psychotherapy, University of Cologne, Cologne, Germany; German Center for Neurodegenerative Diseases (DZNE), Bonn, Germany.
¹⁴ Department of Neurobiology, Care Sciences and Society, Center for Alzheimer Research, Division of Clinical Geriatrics, Karolinska Institutet, Stockholm, Sweden; Aging Theme, Karolinska University Hospital Stockholm, Sweden; University of Eastern Finland, Finland; School of Public Health, Imperial College, London, United Kingdom.
¹⁵ Barcelonaβeta Brain Research Center, Pasqual Maragall Foundation, Barcelona, Spain.
¹⁶ Department of Neurobiology, Care Sciences and Society, Center for Alzheimer Research, Division of Clinical Geriatrics, Karolinska Institutet, Stockholm, Sweden; Aging Theme, Karolinska University Hospital Stockholm, Sweden.
¹⁷ Nuclear Medicine Department, University Hospital of Toulouse (CHU-Toulouse), Toulouse, France; ToNIC, Toulouse NeuroImaging Center, Université de Toulouse, Inserm, UPS, Toulouse, France.
¹⁸ Centre for Clinical Brain Sciences, Department of Psychiatry, University of Edinburgh, Edinburgh, United Kingdom.
¹⁹ Nuclear Medicine IRA, Medical Radiation Physics and Nuclear Medicine Imaging, Karolinska University Hospital, Sweden.
²⁰ Alzheimer Center and Department of Neurology, Amsterdam Neuroscience, VU University Medical Center, Amsterdam, the Netherlands.
²¹ Experimental Medicine, Janssen Pharmaceutica NV, Beerse, Belgium.
²² Institute of Neurology, University College London, London, United Kingdom.
²³ Piramal Imaging, Clinical Research and Development, Berlin, Germany.
²⁴ Gerontopole of Toulouse, University Hospital of Toulouse (CHU-Toulouse), Toulouse, France; UMR INSERM 1027, University of Toulouse III, Toulouse, France.
²⁵ Division of Psychiatry, University College London, London, United Kingdom; Essex Partnership University NHS Foundation Trust, United Kingdom.
²⁶ Piramal Imaging, Market Access and HEOR, Berlin, Germany.

PMID: 30339801
DOI: 10.1016/j.jalz.2018.09.003

Free article

AMYPAD Diagnostic and Patient Management Study: Rationale and design

Giovanni B Frisoni et al. Alzheimers Dement. 2019 Mar.

Free article

. 2019 Mar;15(3):388-399.

doi: 10.1016/j.jalz.2018.09.003. Epub 2018 Oct 16.

Authors

Affiliations

¹ Laboratory of Neuroimaging of Aging (LANVIE), University of Geneva, Geneva, Switzerland; Memory Clinic, University Hospital of Geneva, Geneva, Switzerland; Laboratory of Alzheimer's Neuroimaging and Epidemiology (LANE), Saint John of God Clinical Research Centre, Brescia, Italy. Electronic address: giovanni.frisoni@unige.ch.
² Department of Radiology and Nuclear Medicine, Amsterdam Neuroscience, VU University Medical Center, Amsterdam, the Netherlands; Institutes of Neurology and Healthcare Engineering, UCL, London, United Kingdom.
³ Laboratory of Alzheimer's Neuroimaging and Epidemiology (LANE), Saint John of God Clinical Research Centre, Brescia, Italy; Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy.
⁴ Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, the Netherlands.
⁵ Laboratory of Neuroimaging of Aging (LANVIE), University of Geneva, Geneva, Switzerland; Laboratory of Alzheimer's Neuroimaging and Epidemiology (LANE), Saint John of God Clinical Research Centre, Brescia, Italy.
⁶ Laboratory of Neuroimaging of Aging (LANVIE), University of Geneva, Geneva, Switzerland.
⁷ Department of Radiology and Nuclear Medicine, Amsterdam Neuroscience, VU University Medical Center, Amsterdam, the Netherlands.
⁸ Department of Nuclear Medicine, University Hospital of Cologne, University of Cologne and German Center for Neurodegenerative Diseases (DZNE), Germany.
⁹ Life Sciences, GE Healthcare, Amersham, Buckinghamshire, United Kingdom.
¹⁰ Division of Nuclear Medicine and Molecular Imaging, Department of Medical Imaging, University Hospitals of Geneva, Geneva, Switzerland; NIMTlab, Faculty of Medicine, Geneva University, Geneva, Switzerland.
¹¹ Piramal Imaging, Medical Affairs, Berlin, Germany.
¹² Barcelonaβeta Brain Research Center, Pasqual Maragall Foundation, Barcelona, Spain; Centro de Investigación Biomédica en Red de Bioingeniería, Biomateriales y Nanomedicina (CIBER-BBN), Madrid, Spain.
¹³ Department of Psychiatry and Psychotherapy, University of Cologne, Cologne, Germany; German Center for Neurodegenerative Diseases (DZNE), Bonn, Germany.
¹⁴ Department of Neurobiology, Care Sciences and Society, Center for Alzheimer Research, Division of Clinical Geriatrics, Karolinska Institutet, Stockholm, Sweden; Aging Theme, Karolinska University Hospital Stockholm, Sweden; University of Eastern Finland, Finland; School of Public Health, Imperial College, London, United Kingdom.
¹⁵ Barcelonaβeta Brain Research Center, Pasqual Maragall Foundation, Barcelona, Spain.
¹⁶ Department of Neurobiology, Care Sciences and Society, Center for Alzheimer Research, Division of Clinical Geriatrics, Karolinska Institutet, Stockholm, Sweden; Aging Theme, Karolinska University Hospital Stockholm, Sweden.
¹⁷ Nuclear Medicine Department, University Hospital of Toulouse (CHU-Toulouse), Toulouse, France; ToNIC, Toulouse NeuroImaging Center, Université de Toulouse, Inserm, UPS, Toulouse, France.
¹⁸ Centre for Clinical Brain Sciences, Department of Psychiatry, University of Edinburgh, Edinburgh, United Kingdom.
¹⁹ Nuclear Medicine IRA, Medical Radiation Physics and Nuclear Medicine Imaging, Karolinska University Hospital, Sweden.
²⁰ Alzheimer Center and Department of Neurology, Amsterdam Neuroscience, VU University Medical Center, Amsterdam, the Netherlands.
²¹ Experimental Medicine, Janssen Pharmaceutica NV, Beerse, Belgium.
²² Institute of Neurology, University College London, London, United Kingdom.
²³ Piramal Imaging, Clinical Research and Development, Berlin, Germany.
²⁴ Gerontopole of Toulouse, University Hospital of Toulouse (CHU-Toulouse), Toulouse, France; UMR INSERM 1027, University of Toulouse III, Toulouse, France.
²⁵ Division of Psychiatry, University College London, London, United Kingdom; Essex Partnership University NHS Foundation Trust, United Kingdom.
²⁶ Piramal Imaging, Market Access and HEOR, Berlin, Germany.

PMID: 30339801
DOI: 10.1016/j.jalz.2018.09.003

Erratum in

Corrigendum to "AMYPAD Diagnostic and Patient Management Study: Rationale and design" [Alzheimer's & Dementia 2019;15:388-99].
[No authors listed] [No authors listed] Alzheimers Dement. 2019 Nov;15(11):1505. doi: 10.1016/j.jalz.2019.10.001. Alzheimers Dement. 2019. PMID: 31753289 No abstract available.

Abstract

Introduction: Reimbursement of amyloid-positron emission tomography (PET) is lagging due to the lack of definitive evidence on its clinical utility and cost-effectiveness. The Amyloid Imaging to Prevent Alzheimer's Disease-Diagnostic and Patient Management Study (AMYPAD-DPMS) is designed to fill this gap.

Methods: AMYPAD-DPMS is a phase 4, multicenter, prospective, randomized controlled study. Nine hundred patients with subjective cognitive decline plus, mild cognitive impairment, and dementia possibly due to Alzheimer's disease will be randomized to ARM1, amyloid-PET performed early in the diagnostic workup; ARM2, amyloid-PET performed after 8 months; and ARM3, amyloid-PET performed whenever the physician chooses to do so.

Endpoints: The primary endpoint is the difference between ARM1 and ARM2 in the proportion of patients receiving a very-high-confidence etiologic diagnosis after 3 months. Secondary endpoints address diagnosis and diagnostic confidence, diagnostic/therapeutic management, health economics and patient-related outcomes, and methods for image quantitation.

Expected impacts: AMYPAD-DPMS will supply physicians and health care payers with real-world data to plan management decisions.

Keywords: Alzheimer's disease; Amyloid-PET; Clinical validity; Cost-effectiveness; Mild cognitive impairment; Subjective cognitive decline.

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AMYPAD Diagnostic and Patient Management Study: Rationale and design

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AMYPAD Diagnostic and Patient Management Study: Rationale and design

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Erratum in

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