Neuropsychiatric Symptoms in AD: Clinical Trials Targeting Mild Behavioral Impairment: A Report from the International CTAD Task Force

Maria Soto, P. Rosenberg, C. Ballard, B. Vellas, D. Miller, S. Gauthier, M. C. Carrillo, C. Lyketsos, Z. Ismail, Susan Abushakra, Mohammad Afshar, Sam Agus, Paul Aiden, John Alam, Alicia Algeciras-Schimnich, Sandrine Andrieu, Amos Baruch, Randall Bateman, Richard Batrla, Monika BaudlerJoanne Bell, Tobias Bittner, Sasha Bozeat, Joel Braunstein, Dawn Brooks, Tricia Brooks, Szofia Bullain, Jan Burmeister, Maria Carrillo, Min Cho, Emily Collins, Gavin Cook, Chris Dague, Susan De Santi, Rachelle Doody, Billy Dunn, Michael Egan, Sven Eriksson, Rianne Esquivel, Tom Fagan, Phyllis Ferrell, Howard Fillit, Michela Gallagher, Anna Kaija Grönblad, Avis Hains, Harald Hampel, Oskar Hansson, Nanco Hefting, Suzanne Hendrix, Carole Ho, Helen Hu, Daryl Jones, Gene Kinney, Paul Kinnon, Ricky Kurzman, Lars Lannfelt, John Lawson, Nathalie LeBastard, Valérie Legrand, Nicole Lewandowski, Carine Lim, Donna Masterman, Colin Masters, Ming Lu, Mark Mintun, José Luis Molinuevo, Cecilia Monteiro, Bradford Navia, Tomas Odergren, Gunilla Osswald, Lewis Penny, Michael Pontecorvo, Anton Porsteinsson, Christine Rabe, Rema Raman, Gesine Respondek, Larisa Reyderman, Sharon Rogers, Paul Rosenberg, Sharon Rosenzweig-Lipson, Mark Roskey, Rubel Carrie, Ziad Saad, Stephen Salloway, Rachel Schindler, Dennis Selkoe, Melanie Shulman, John Sims, Kaycee Sink, Lisa Sipe, Daniel Skovronsky, Elizabeth Somers, Johannes Streffer, Pedro Such, Joyce Suhy, Masoud Toloue, Jacques Touchon, Manu Vandijck, Michael Weiner, Anne White, David Wilson, Wagner Zago, Jin Zhou

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

Abstract

The International CTAD Task Force (TF) addressed challenges related to designing clinical trials for agitation in dementia, presenting accomplishments from the two previous TFs on neuropsychiatric symptoms (NPS). In addition, this TF proposed a paradigm shift in NPS assessment and management, presenting Mild Behavioral Impairment (MBI) as a clinical syndrome. MBI is marked by later-life emergent and persistent NPS in dementia-free older persons (ranging from cognitively unimpaired to subjective cognitive decline to mild cognitive impairment), which facilitates earlier detection and better prognostication of Alzheimer’s disease (AD). The TF has made the following recommendations for incorporation of NPS into AD preventative trials: (1) clinical trials targeting improvement in MBI symptoms should be undertaken; (2) treatment trials for MBI should be disease specific and confirm the diagnosis of participants using biomarkers; trials should include measures sensitive to cognitive changes in preclinical AD, which can serve as outcome measures, in addition to changes in biomarker levels; (3) as a first step, pharmacotherapeutic trials should address the full MBI complex as well as the specific symptoms/domains that constitute MBI; (4) clinical trials using problemadaptation psychotherapy to target affective MBI should be considered; and (5) MBI should be considered in AD trials of disease modifying therapies. The well-validated and widely-used MBI Checklist (MBI-C) is an appropriate symptom rating scale for these studies, as it was developed specifically to identify and measure MBI in dementia-free persons. Other scales such as the Neuropsychiatric Inventory (NPI) may be used, although administration at two timepoints may be necessary to operationalize the MBI criterion of symptom persistence.

Original languageEnglish
Pages (from-to)56-64
Number of pages9
JournalThe journal of prevention of Alzheimer's disease
Volume11
Issue number1
DOIs
StatePublished - Jan 2024

Keywords

  • Alzheimer’s disease
  • Neuropsychiatric symptoms
  • agitation
  • clinical trials
  • dementia
  • mild behavioral impairment

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