The Future of AD Clinical Trials with the Advent of Anti-Amyloid Therapies: An CTAD Task Force Report - 21/11/24
, R.J. Bateman 3, 4, J. Touchon 5, M. Sabbagh 6, J. Cummings 7
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Abstract |
BACKGROUND: Aducanumab (ADUHELM™) was approved for the treatment of Alzheimer’s disease (AD) in the US. This approval was supported by an effect on the cerebral amyloid plaque load and evidence of cognitive efficacy to be confirmed in post-marketing trials. Other anti-amyloid antibodies are under investigation in phase III (donanemab, lecanemab, gantenerumab) and have shown preliminary evidence of a cognitive benefit in phase II trials. Although these agents target a small segment of patients with mild cognitive impairment due to AD or mild AD dementia, their advent will change the design of future clinical trials both for anti-amyloid and non-amyloid drugs. These changes will promote the selection of patients in clinical trials by amyloid and tau biomarkers that identify patients with appropriate biology and may follow the treatment response to approved amyloid antibodies. The use of these agents creates the opportunity to test combined drug therapies and to conduct comparative assessments with innovative therapies and newly approved drugs available in clinical practice. Blood-based AD biomarkers should be implemented in research and could facilitate the recruitment into clinical trials. Anti-amyloid antibodies will have positive (e.g., more early diagnosis) and negative impacts (some subjects will be reluctant to participate in trials and risk assignment to placebo) on AD trials in the immediate future. We present the results of the CTAD Task Force on this topic, in Boston, November 6, 2021.
Le texte complet de cet article est disponible en PDF.Key words : Alzheimer disease, clinical trial, anti-amyloid therapy, biomarker
Plan
| CTAD Task Force members: Susan Abushakra (Framingham, USA); Paul Aisen (San Diego, USA); Sandrine Andrieu (Toulouse, France); Matthew Barton (Raleigh, USA); Monika Baudler (Basel, Switzerland); Joanne Bell (Willmington, USA); Tobias Bittner (Basel, Switzerland); Adam Boxer (San Francisco, USA); Dawn Brooks (Indianapolis, USA); Mirek Brys (Indianapolis, USA); Szofia Bullain (South San Francisco, USA); Cherie Butts (Cambridge, USA); Maria Carrillo (Chicago, USA); Carmen Castrillo-Viguera (Cambridge, USA); Bill Chan (Beijing, China); Ivan Cheung (Woodcliff Lake, USA); Min Cho (Woodcliff Lake, USA); Suzanne Craft (Winston-Salem, USA); Michael Detke (San Francisco, USA); Shobha Dhadda (Woodcliff Lake, USA); Rachelle Doody (Basel, Switzerland); Sanjay Dube (Viejo, USA); Billy Dunn (Beltsville, USA); Michael Egan (North Wales, USA); Rianne Esquivel (Malvern, USA); Colin Ewen (United Kingdom); Phyllis Ferrel (Indianapolis, USA); Michela Gallagher (Baltimore, USA); Wendy Galpern (New Jersey, USA); Hideki Garren (San Francisco, USA); Grönblad Anna-Kaija (Stockholm, Sweden); Juergen Haeussler (Titusville, USA); Harald Hampel (Woodcliff Lake, USA); Suzanne Hendrix (Salt Lake City, USA); Joseph Herring (North Wales, USA); Michael Irizarry (Woodcliff Lake, USA); Takeshi Iwatsubo (Tokyo, Japan); Gene Kinney (San Francisco, USA); David Knopman (Rochester, USA); Hartmuth Kolb (Titusville, USA); Shailaja Korukonda (Woodcliff Lake, USA); Akihiko Koyama (Woodcliff Lake, USA); Lynn Kramer (Woodcliff Lake, USA); Luka Kulic (Basel, Switzerland); Ricky Kurzman (Woodcliff Lake, USA); Jaren Landen (Cambridge, USA); Lars Lannfelt (Uppsala, Sweden); John Lawson (Malvern, USA); Valérie Legrand (Nanterre, France); Jinhe Li (Gilbert, USA); Frank Longo (Stanford, USA); Manoj Malhotra (Woodcliff Lake, USA); William Menard (Providence, USA); Mark Mintun (Indianapolis, USA); Cecilia Monteiro (South San Francisco, USA); Stacie O’Sullivan (Woodcliff Lake, USA); Tomas Odergren (Stockholm, Sweden); Gunilla Osswald (Stockholm, Sweden); Ronald Petersen (Rochester, USA); Michael Pontecorvo (Indianapolis, USA); Mary Ellen Quiceno (New Jersey, USA); Rema Raman (San Diego, USA); Larisa Reyderman (Woodcliff Lake, USA); Monica Rivera-Mindt (Bronx, USA); Sharon Rogers (Los Angeles, USA); Sharon Rosenzweig-Lipson (Baltimore, USA); Ivana Rubino (Cambridge, USA); Laurie Ryan (Bethesda, USA); Stephen Salloway (Providence, USA); Rachel Schindler (New York, USA); Lon Schneider (Los Angeles, USA); Peter Schüler (Langen, Germany); Hiroshi Sekiya (Malvern, USA); Dennis Selkoe (Boston, USA); Melanie Shulman (Cambridge, USA); Eric Siemers ((Zionsville, USA); John Sims (Indianapolis, USA) Kaycee Sink (South San Francisco, USA); Reisa Sperling (Boston, USA); Joyce Suhy (San Mateo, USA); Chad Swanson (Woodcliff Lake, USA); Jina Swartz (London, United Kingdom); Pierre Tariot (Phoenix, USA); Edmond Teng (South San Francisco, USA); Martin Traber (Basel, Switzerland); Dominic Walsh (Cambridge, USA); Michael Weiner (San Francisco, USA); Lisa Yarenis (Woodcliff Lake, USA); Wagner Zago (San Francisco, USA); Kenton Zavitz (Cambridge, United Kingdom). How to cite this article: J. Delrieu, R.J. Bateman, J. Touchon, et al. The Future of AD Clinical Trials with the Advent of Anti-Amyloid Therapies: An CTAD Task Force Report. J Prev Alz Dis 2022;3(9):393-399; jpad.2022.48 |
Vol 9 - N° 3
P. 393-399 - juillet 2022 Retour au numéro
Article précédent
- Tackling a Major Deficiency of Diversity in Alzheimer’s Disease Therapeutic Trials: An CTAD Task Force Report
- Rema Raman, P. Aisen, M.C. Carillo, M. Detke, J.D. Grill, O.C. Okonkwo, M. Rivera-Mindt, M. Sabbagh, B. Vellas, M. Weiner, R. Sperling, CTAD Task Force
- Prediction of Cognitive Decline for Enrichment of Alzheimer’s Disease Clinical Trials
- A. Tam, C. Laurent, S. Gauthier, Christian Dansereau, Alzheimer’s Disease Neuroimaging Initiative
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