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. 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.
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.
RCT Entities:
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.
Authors: Victor L Villemagne; Frederik Barkhof; Valentina Garibotto; Susan M Landau; Agneta Nordberg; Bart N M van Berckel Journal: Radiology Date: 2021-01-19 Impact factor: 11.105
Authors: Matteo Cotta Ramusino; Giulia Perini; Daniele Altomare; Paola Barbarino; Wendy Weidner; Gabriella Salvini Porro; Frederik Barkhof; Gil D Rabinovici; Wiesje M van der Flier; Giovanni B Frisoni; Valentina Garibotto; Stefan Teipel; Marina Boccardi Journal: Eur J Nucl Med Mol Imaging Date: 2021-02-17 Impact factor: 9.236
Authors: Katherine W Turk; Ana Vives-Rodriguez; Kylie A Schiloski; Anna Marin; Ryan Wang; Prabhjyot Singh; Gabor P Hajos; Rachel Powsner; Renée DeCaro; Andrew E Budson Journal: Alzheimers Dement (N Y) Date: 2022-08-17
Authors: Hugh G Pemberton; Lyduine E Collij; Fiona Heeman; Ariane Bollack; Mahnaz Shekari; Gemma Salvadó; Isadora Lopes Alves; David Vallez Garcia; Mark Battle; Christopher Buckley; Andrew W Stephens; Santiago Bullich; Valentina Garibotto; Frederik Barkhof; Juan Domingo Gispert; Gill Farrar Journal: Eur J Nucl Med Mol Imaging Date: 2022-04-07 Impact factor: 10.057
Authors: Ingrid S van Maurik; Laura M van der Kall; Arno de Wilde; Femke H Bouwman; Philip Scheltens; Bart N M van Berckel; Johannes Berkhof; Wiesje M van der Flier Journal: Alzheimers Dement (Amst) Date: 2019-07-29
Authors: Lyduine E Collij; Gemma Salvadó; Mahnaz Shekari; Isadora Lopes Alves; Juhan Reimand; Alle Meije Wink; Marissa Zwan; Aida Niñerola-Baizán; Andrés Perissinotti; Philip Scheltens; Milos D Ikonomovic; Adrian P L Smith; Gill Farrar; José Luis Molinuevo; Frederik Barkhof; Christopher J Buckley; Bart N M van Berckel; Juan Domingo Gispert Journal: Eur J Nucl Med Mol Imaging Date: 2021-02-22 Impact factor: 9.236