Citations 4
A framework for translating tauopathy therapeutics: Drug discovery to clinical trials
Feldman, Howard , Cummings, Jeffrey L., Boxer, Adam L., Staffaroni, Adam M. , Knopman, David S., Territo, Paul R. , Arnold, Steven E. , Boeve, Bradley F., Dacks, Penny A. , Diaz, Kristophe , Ewen, Colin, González, María Isabel , Harris, Glenn A., Hoffman, Beth J., Martinez, Terina N. , Nisenbaum, Laura K., Palma, Jose‐Alberto , Quintana, Melanie , Rabinovici, Gil D. , Rohrer, Jonathan D. , Rosen, Howard J., Troyer, Matthew D. , Kim, Doo Yeon , Tanzi, Rudolph E. , Zetterberg, Henrik, Ziogas, Nick, May, Patrick C. , Rommel, Amy, Feldman, Howard H , Palma, Jose-Alberto , Rohrer, Jonathan D , Rabinovici, Gil D , Dacks, Penny , Boxer, Adam L. , Knopman, David S. , Rizzo, Stacey J. Sukoff , Ballard, Clive , Beher, Dirk , Boeve, Bradley F. , Fiske, Brian , McDade, Eric , Zetterberg, Henrik
Alzheimer's & Dementia | September 24, 2024 | Volume: 20 | Issue: 11 | Pages: 8129-8152
AbstractThe tauopathies are defined by pathological tau protein aggregates within a spectrum of clinically heterogeneous neurodegenerative diseases. The primary tauopathies meet the definition of rare diseases in the United States. There is no approved treatment for primary tauopathies. In this context, designing the most efficient development programs to translate promising targets and treatments from preclinical studies to early‐phase clinical trials is vital. In September 2022, the Rainwater Charitable Foundation convened an international expert workshop focused on the translation of tauopathy therapeutics through early‐phase trials. Our report on the workshop recommends a framework for principled drug development and a companion lexicon to facilitate communication focusing on reproducibility and achieving common elements. Topics include the selection of targets, drugs, biomarkers, participants, and study designs. The maturation of pharmacodynamic biomarkers to demonstrate target engagement and surrogate disease biomarkers is a crucial unmet need.Highlights Experts provided a framework to translate therapeutics (discovery to clinical trials). Experts focused on the “5 Rights” (target, drug, biomarker, participants, trial). Current research on frontotemporal degeneration, progressive supranuclear palsy, and corticobasal syndrome therapeutics includes 32 trials (37% on biologics) Tau therapeutics are being tested in Alzheimer's disease; primary tauopathies have a large unmet need.
Research criteria for the diagnosis of prodromal dementia with Lewy bodies
McKeith, Ian G. , Ferman, Tanis J. , Thomas, Alan , Blanc, Frédéric , Boeve, Bradley F. , Fujishiro, Hiroshige , Kantarci, Kejal , Muscio, Cristina , O’Brien, John T. , Ballard, Clive , Donaghy, Paul C. , Emre, Murat, Goldman, Jennifer G. , Gomperts, Stephen N. , Ikeda, Manabu , Lewis, Simon J.G. , Marder, Karen, Salmon, David P. , Taylor, John‐Paul , Walker, Zuzana , Tiraboschi, Pietro , Group, for the prodromal DLB Diagnostic Study, Thomas, Alan J , Ballard, Clive , Bonanni, Laura , Donaghy, Paul , Gomperts, Stephen N , Honig, Lawrence S. , Leverenz, James B , Lewis, Simon J G , Marder, Karen S, Taylor, John Paul , Tsuang, Debby W. , Walker, Zuzana , O'Brien, John Tiernan , Goldman, Jennifer G , Boeve, Brad , Kantarci, Kejal , Ferman, Tanis J , Tiraboschi, Pietro , Postuma, Ronald B. , Aarsland, Dag , Galvin, James E. , Galasko, Douglas , Leverenz, James B. , Masellis, Mario , Group, for the prodromal DLB Diagnostic Study
Neurology | April 2, 2020 | Volume: 94 | Issue: 17 | Pages: 743-755
Revisiting Criteria for Psychosis in Alzheimer’s Disease and Related Dementias: Toward Better Phenotypic Classification and Biomarker Research
Ismail, Zahinoor , Youakim, James M. , Kumar, Sanjeev , Núñez, Nicolás A. , Darby, R. Ryan , D’Antonio, Fabrizia , Lena, Carlo de , McGeown, William J. , Ravona, Ramit, Rasmussen, J , Bell, J. Simon , Wang, Huali , Bruneau, Marie‐Andrée , Agüera-Ortíz, Luis , Lyketsos, Constantine G. , Sano, Mary , Devanand, Davangere P. , Ballard, Clive , Nunez, Nicolas, Ballard, Clive , Fischer, Corinne Eleanor , Creese, Byron , Vita, Antonella Di , Panegyres, Peter K. , Lanctôt, Krista L. , Cummings, Jeffrey L. , Jeste, Dilip V. , Sweet, Robert A.
Journal of Alzheimer’s Disease | December 27, 2019 | Volume: 73 | Issue: 3 | Pages: 1143-1156
Background: Psychotic symptoms are common in Alzheimer’s disease (AD) and related neurodegenerative disorders and are associated with more rapid disease progression and increased mortality. It is unclear to what degree existing criteria are utilized in clinical research and practice. Objective: To establish research criteria for the diagnosis of psychosis in AD. Methods: The International Society to Advance Alzheimer’s Research and Treatment (ISTAART) Neuropsychiatric Symptoms (NPS) Professional Interest Area (PIA) psychosis subgroup reviewed existing criteria for psychosis in AD and related dementias. Through a series of in person and on-line meetings, a priority checklist was devised to capture features necessary for current research and clinical needs. PubMed, Medline and other relevant databases were searched for relevant criteria. Results: Consensus identified three sets of criteria suitable for review including those of Jeste and Finkel, Lyketsos, and the Diagnostic and Statistical Manual for Mental Disorders, 5th edition. It was concluded that existing criteria could be augmented by including a more specific differentiation between delusions and hallucinations, address overlap with related conditions (agitation in particular), adding the possibility of symptoms emerging in the preclinical and prodromal phases, and building on developing research in disease biomarkers. Conclusion: We propose criteria, developed to improve phenotypic classification of psychosis in AD, and advance the research agenda in the field to improve epidemiological, biomarker, and genetics research in the field. These criteria serve as a complement to the International Psychogeriatric Association criteria for psychosis in neurocognitive disorders.
Neuropsychiatric symptoms in Alzheimer's disease: Past progress and anticipation of the future
Geda, Yonas E. , Schneider, Lon S. , Gitlin, Laura N. , Smith, Gwenn S. , Evans, Jovier D., Lee, Michael K. , Porsteinsson, Anton P. , Lanctôt, Krista L. , Rosenberg, Paul B. , Sultzer, David L. , Francis, Paul T. , Brodaty, Henry , Padala, Prasad P., Onyike, Chiadikaobi, Ortiz, Luis Agüera, Vitiello, Michael V. , Yaffe, Kristine , Zee, Phyllis C. , Herrmann, Nathan , Ballard, Clive , Khin, Ni A. , Alfaro, Cara L., Murray, Patrick S. , Schultz, Susan K. , Lyketsos, Constantine G. , ISTAART, Neuropsychiatric Syndromes Professional Interest Area of, Miller, David S. , Bell, J. Simon , Padala, Prasad R. , Ancoli‐Israel, Sonia , Bliwise, Donald L. , Martin, Jennifer L. , Sweet, Robert A. , ISTAART, Neuropsychiatric Syndromes Professional Interest Area of, Lanctôt, Krista L , Brodaty, Henry , Ballard, Clive , Geda, Yonas E
Alzheimer's & Dementia | April 4, 2013 | Volume: 9 | Issue: 5 | Pages: 602-608
Abstract Neuropsychiatric symptoms (NPS) in Alzheimer's disease (AD) are widespread and disabling. This has been known since Dr. Alois Alzheimer's first case, Frau Auguste D., presented with emotional distress and delusions of infidelity/excessive jealousy, followed by cognitive symptoms. Being cognizant of this, in 2010 the Alzheimer's Association convened a research roundtable on the topic of NPS in AD. A major outcome of the roundtable was the founding of a Professional Interest Area (PIA) within the International Society to Advance Alzheimer's Research and Treatment (ISTAART). The NPS‐PIA has prepared a series of documents that are intended to summarize the literature and provide more detailed specific recommendations for NPS research. This overview paper is the first of these living documents that will be updated periodically as the science advances. The overview is followed by syndrome‐specific synthetic reviews and recommendations prepared by NPS‐PIA workgroups on depression, apathy, sleep, agitation, and psychosis.