Clinical Effect of Early vs Late Amyloid Positron Emission Tomography in Memory Clinic Patients : The AMYPAD-DPMS Randomized Clinical Trial

Article Article scientifique Article Clinical Effect of Early vs Late Amyloid Positron Emission Tomography in Memory Clinic Patients : The AMYPAD-DPMS Randomized Clinical Trial eng 2023-06-01 author Altomare Daniele Laboratory of Neuroimaging of Aging (LANVIE), University of Geneva, Geneva, Switzerland.,Geneva Memory Center, Geneva University Hospitals, Geneva, Switzerland.,Neurology Unit, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy. 917820 author Barkhof Frederik Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centers (UMC)-Location VUmc, Amsterdam, the Netherlands.,Institute of Neurology, Institute of Healthcare Engineering, University College London, London, United Kingdom. author Caprioglio Camilla Laboratory of Neuroimaging of Aging (LANVIE), University of Geneva, Geneva, Switzerland.,Geneva Memory Center, Geneva University Hospitals, Geneva, Switzerland. 936006 author Collij Lyduine E Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centers (UMC)-Location VUmc, Amsterdam, the Netherlands. author Scheltens Philip Alzheimer Center, Department of Neurology, Amsterdam University Medical Centers-Location VUmc, Amsterdam, the Netherlands. author Lopes Alves Isadora Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centers (UMC)-Location VUmc, Amsterdam, the Netherlands. author Bouwman Femke Alzheimer Center, Department of Neurology, Amsterdam University Medical Centers-Location VUmc, Amsterdam, the Netherlands. author Berkhof Johannes Department of Epidemiology and Data Science, Amsterdam University Medical Centers-Location VUmc, Amsterdam, the Netherlands. author van Maurik Ingrid S Alzheimer Center, Department of Neurology, Amsterdam University Medical Centers-Location VUmc, Amsterdam, the Netherlands.,Department of Epidemiology and Data Science, Amsterdam University Medical Centers-Location VUmc, Amsterdam, the Netherlands. author Garibotto Valentina 0000-0003-2422-698X Laboratory of Neuroimaging and Innovative Molecular Tracers (NIMTlab), Geneva University Neurocenter and Faculty of Medicine, University of Geneva, Geneva, Switzerland.,Division of Nuclear Medicine and Molecular Imaging, Geneva University Hospitals, Geneva, Switzerland. 704817 Département de radiologie et informatique médicale (RADIO) author Moro Christian Laboratory of Neuroimaging of Aging (LANVIE), University of Geneva, Geneva, Switzerland.,Geneva Memory Center, Geneva University Hospitals, Geneva, Switzerland. 507083 author Delrieu Julien Gérontopôle, Department of Geriatrics, Toulouse University Hospital, Toulouse, France.,Maintain Aging Research Team, CERPOP, Inserm, Université Paul Sabatier, Toulouse, France. author Payoux Pierre Department of Nuclear Medicine, Toulouse University Hospital, Toulouse, France.,Toulouse NeuroImaging Center (ToNIC), UMR1214 Inserm, Université de Toulouse III, Toulouse, France. author Saint-Aubert Laure Department of Nuclear Medicine, Toulouse University Hospital, Toulouse, France.,Toulouse NeuroImaging Center (ToNIC), UMR1214 Inserm, Université de Toulouse III, Toulouse, France. author Hitzel Anne Department of Nuclear Medicine, Toulouse University Hospital, Toulouse, France. author Molinuevo José Luis Barcelonaβeta Brain Research Center (BBRC), Pasqual Maragall Foundation, Barcelona, Spain.,H. Lundbeck, Copenhagen, Denmark. author Grau-Rivera Oriol Barcelonaβeta Brain Research Center (BBRC), Pasqual Maragall Foundation, Barcelona, Spain.,Hospital del Mar Medical Research Institute (IMIM), Barcelona, Spain.,Centro de Investigación Biomédica en Red de Fragilidad y Envejecimiento Saludable (CIBERFES), Madrid, Spain. author Gispert Juan Domingo Barcelonaβeta Brain Research Center (BBRC), Pasqual Maragall Foundation, Barcelona, Spain.,Hospital del Mar Medical Research Institute (IMIM), Barcelona, Spain.,Centro de Investigación Biomédica en Red Bioingeniería, Biomateriales y Nanomedicina (CIBER-BBN), Barcelona, Spain. author Drzezga Alexander Department of Nuclear Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.,German Center for Neurodegenerative Diseases (DZNE), Bonn-Cologne, Germany.,Institute of Neuroscience and Medicine (INM-2), Molecular Organization of the Brain, Forschungszentrum Jülich, Germany. author Jessen Frank German Center for Neurodegenerative Diseases (DZNE), Bonn-Cologne, Germany.,Department of Psychiatry, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.,Excellence Cluster Cellular Stress Responses in Aging-Related Diseases (CECAD), Medical Faculty, University of Cologne, Cologne, Germany. author Zeyen Philip Department of Psychiatry, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany. author Nordberg Agneta Department of Neurobiology, Care Sciences and Society, Center of Alzheimer Research, Karolinska Institutet, Stockholm, Sweden.,Theme Aging, Karolinska University Hospital, Stockholm, Sweden. author Savitcheva Irina Medical Radiation Physics and Nuclear Medicine, Section for Nuclear Medicine, Karolinska University Hospital, Stockholm, Sweden. author Jelic Vesna Kristina Cognitive Disorders Clinic, Theme Inflammation and Aging, Karolinska University Hospital-Huddinge, Stockholm, Sweden. 415339 author Walker Zuzana Division of Psychiatry, University College London, London, United Kingdom.,St Margaret's Hospital, Essex Partnership University NHS Foundation Trust, Essex, United Kingdom. author Edison Paul Division of Neurology, Department of Brain Sciences, Imperial College London, London, United Kingdom. author Demonet Jean-François Leenaards Memory Center, Lausanne University Hospital (CHUV), Lausanne, Switzerland. author Gismondi Rossella Life Molecular Imaging, Berlin, Germany. author Farrar Gill GE Healthcare, Amersham, United Kingdom. author Stephens Andrew W Life Molecular Imaging, Berlin, Germany. author Frisoni Giovanni Laboratory of Neuroimaging of Aging (LANVIE), University of Geneva, Geneva, Switzerland.,Geneva Memory Center, Geneva University Hospitals, Geneva, Switzerland. 810190 dept de réadaptation et gériatrie (MIGRG) Amyloid Imaging to Prevent Alzheimer’s Disease (AMYPAD) Consortium 548-557 10.1001/jamaneurol.2023.0997 37155177 2168-6149 PMC10167601 https://jamanetwork.com/journals/jamaneurology/fullarticle/2804755 Importance: Amyloid positron emission tomography (PET) allows the direct assessment of amyloid deposition, one of the main hallmarks of Alzheimer disease. However, this technique is currently not widely reimbursed because of the lack of appropriately designed studies demonstrating its clinical effect. Objective: To assess the clinical effect of amyloid PET in memory clinic patients. Design, setting, and participants: The AMYPAD-DPMS is a prospective randomized clinical trial in 8 European memory clinics. Participants were allocated (using a minimization method) to 3 study groups based on the performance of amyloid PET: arm 1, early in the diagnostic workup (within 1 month); arm 2, late in the diagnostic workup (after a mean [SD] 8 [2] months); or arm 3, if and when the managing physician chose. Participants were patients with subjective cognitive decline plus (SCD+; SCD plus clinical features increasing the likelihood of preclinical Alzheimer disease), mild cognitive impairment (MCI), or dementia; they were assessed at baseline and after 3 months. Recruitment took place between April 16, 2018, and October 30, 2020. Data analysis was performed from July 2022 to January 2023. Intervention: Amyloid PET. Main outcome and measure: The main outcome was the difference between arm 1 and arm 2 in the proportion of participants receiving an etiological diagnosis with a very high confidence (ie, ≥90% on a 50%-100% visual numeric scale) after 3 months. Results: A total of 844 participants were screened, and 840 were enrolled (291 in arm 1, 271 in arm 2, 278 in arm 3). Baseline and 3-month visit data were available for 272 participants in arm 1 and 260 in arm 2 (median [IQR] age: 71 [65-77] and 71 [65-77] years; 150/272 male [55%] and 135/260 male [52%]; 122/272 female [45%] and 125/260 female [48%]; median [IQR] education: 12 [10-15] and 13 [10-16] years, respectively). After 3 months, 109 of 272 participants (40%) in arm 1 had a diagnosis with very high confidence vs 30 of 260 (11%) in arm 2 (P < .001). This was consistent across cognitive stages (SCD+: 25/84 [30%] vs 5/78 [6%]; P < .001; MCI: 45/108 [42%] vs 9/102 [9%]; P < .001; dementia: 39/80 [49%] vs 16/80 [20%]; P < .001). Conclusion and relevance: In this study, early amyloid PET allowed memory clinic patients to receive an etiological diagnosis with very high confidence after only 3 months compared with patients who had not undergone amyloid PET. These findings support the implementation of amyloid PET early in the diagnostic workup of memory clinic patients. Trial registration: EudraCT Number: 2017-002527-21. Humans Male Female Aged Alzheimer Disease / psychology Brain / metabolism Prospective Studies Positron-Emission Tomography Cognitive Dysfunction Amyloid / metabolism Amyloidogenic Proteins Amyloid beta-Peptides / metabolism Dewey 616.0757 Dewey 618.97 Swiss National Science Foundation Individual cognitive risk profiling in aging according to Amyloid, Tau and Neurodegeneration imaging biomarkers 185028 CH Projects Swiss National Science Foundation Strategic roadmap for the translation of tau biomarkers in the clinic: an international task force 188355 CH Science communication Swiss National Science Foundation Brain connectivity and metacognition in persons with subjective cognitive decline (COSCODE): correlation with clinical features and in vivo neuropathology 182772 CH Projects Swiss National Science Foundation CLearing Alzheimer’s disease Molecular Pathology without medications (CLAMP) 196354 CH Projects Swiss National Science Foundation The Biological Basis of Cognitive Impairment due to Suspected Non-Alzheimer’s Pathology (SNAP) : Studying the interplay between amyloidosis and tau-related neurodegeneration 169876 CH Projects 62 Département de radiologie et informatique médicale 227 65 Département de réadaptation et gériatrie 22B false 1222 Laboratoire de neuroimagerie et de traceurs moléculaires innovants 984 853 Troubles de mémoire et maladie d'Alzeimer 935 JAMA neurology 80 6 97888e2f-d41b-47f3-9945-4f7a8b655273 Article (Published version) Public jamaneurology_altomare_2023_oi_2300.pdf 808407 application/pdf CC BY f04efd9906da4615fa422e99093875cb6081b94fba2b71a69d9cc20aed6efdd8 a3fcdeb6-f19e-4e12-a779-ad7e8ff23ecb Supplemental data Public noi230022supp1_prod_1686342381.0735.pdf 5735402 application/pdf ee7306eb53ce12a9184b9bd00e16ce2207fad737d300dad2632b803404d015c8 7d904928-535f-4586-aaee-c52b81173b7b Supplemental data Public noi230022supp2_prod_1686342381.0786.pdf 678600 application/pdf 51808dee195f011cc01be1c3416fc2b5475b850534543082ccfce0b8195b247d b8adc939-67ce-47c1-af80-3bf9d312cf48 Supplemental data Public noi230022supp3_prod_1686342381.0786.pdf 151121 application/pdf 87c7e4b482d965e72bc61bd57f3c10a1609d270a326bfd07657cd86dafcf6133 528e25f8-d9b3-462e-b231-cef6830b7d53 Supplemental data Public noi230022supp4_prod_1686342381.0836.pdf 15699 application/pdf 8d4a5526a8d6b538171f5d58d5a25bf927290906c6bfb19be540a6347e3a1fb3 openAccess Faculté de médecine / Section de médecine clinique / Département de radiologie et informatique médicale Faculté de médecine / Section de médecine clinique / Département de réadaptation et gériatrie

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Clinical Effect of Early vs Late Amyloid Positron Emission Tomography in Memory Clinic Patients : The AMYPAD-DPMS Randomized Clinical Trial	JAMA neurology			2023	77	101

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Jelic, Vesna Kristina