PMID- 37521521
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231128
IS  - 2352-8737 (Electronic)
IS  - 2352-8737 (Linking)
VI  - 9
IP  - 3
DP  - 2023 Jul-Sep
TI  - Meaningful benefit and minimal clinically important difference (MCID) in 
      Alzheimer's disease: Open peer commentary.
PG  - e12411
LID - 10.1002/trc2.12411 [doi]
LID - e12411
AB  - INTRODUCTION: Approval of the anti-amyloid monoclonal antibodies has stimulated 
      an important discussion of the value to be placed on the magnitude of slowing 
      achieved by treatment compared to placebo. METHODS: The minimal clinically 
      important difference (MCID) was reviewed in the context of other measures and 
      analyses that provide perspective on the meaningfulness of treatment responses. 
      RESULTS: TheMCID is a clinician-anchored approach to making this determination. 
      The MCID applies best to symptomatic therapies for which the drug-placebo 
      difference remains constant. Disease-modifying therapies produce a progressive 
      divergence of drug and placebo trajectories; early in the course the MCID would 
      not be achieved, later the MCID will be achieved, and with continuing therapy the 
      MCID will be exceeded. Clinicians are not the only stakeholders involved in 
      determining the value proposition of slowing disease progression. 
      Patient-reported outcomes and caregiver-related measures offer important 
      complementary insights. Analytic approaches also widen the perspective on the 
      observed drug-placebo differences. Risk ratios, numbers needed to treat versus 
      number needed to harm, time-to-event analyses, and predictive benefits based on 
      biomarkers all add depth to the discussion. DISCUSSION: Multiple stakeholder 
      perspectives are needed to determine the importance to be attributed to the 
      therapeutic changes observed with monoclonal antibody therapies and other 
      emerging treatments.
CI  - (c) 2023 The Authors. Alzheimer's & Dementia: Translational Research & Clinical 
      Interventions published by Wiley Periodicals LLC on behalf of Alzheimer's 
      Association.
FAU - Cummings, Jeffrey
AU  - Cummings J
AD  - Chambers-Grundy Center for Transformative Neuroscience Department of Brain Health 
      School of Integrated Health Sciences University of Nevada Las Vegas (UNLV) Las 
      Vegas Nevada USA.
LA  - eng
GR  - P20 AG068053/AG/NIA NIH HHS/United States
GR  - R35 AG071476/AG/NIA NIH HHS/United States
GR  - R25 AG083721/AG/NIA NIH HHS/United States
GR  - P20 GM109025/GM/NIGMS NIH HHS/United States
GR  - R01 AG053798/AG/NIA NIH HHS/United States
PT  - Journal Article
DEP - 20230726
PL  - United States
TA  - Alzheimers Dement (N Y)
JT  - Alzheimer's & dementia (New York, N. Y.)
JID - 101650118
PMC - PMC10372384
COIS- J.C. has provided consultation to Acadia, Actinogen, Acumen, AlphaCognition, 
      Aprinoia, AriBio, Artery, Biogen, BioVie, Cassava, Cerecin, Diadem, EIP Pharma, 
      Eisai, GemVax, Genentech, GAP Innovations, Janssen, Jocasta, Karuna, Lilly, 
      Lundbeck, LSP, Merck, NervGen, Novo Nordisk, Oligomerix, Optoceutics, Ono, 
      Otsuka, PRODEO, Prothena, ReMYND, Roche, Sage Therapeutics, Signant Health, 
      Simcere, Suven, SynapseBio, TrueBinding, Vaxxinity, and Wren pharmaceutical, 
      assessment, and investment companies. Author disclosures are available in the 
      supporting information.
EDAT- 2023/07/31 06:42
MHDA- 2023/07/31 06:43
PMCR- 2023/07/26
CRDT- 2023/07/31 05:10
PHST- 2023/06/23 00:00 [received]
PHST- 2023/06/27 00:00 [accepted]
PHST- 2023/07/31 06:43 [medline]
PHST- 2023/07/31 06:42 [pubmed]
PHST- 2023/07/31 05:10 [entrez]
PHST- 2023/07/26 00:00 [pmc-release]
AID - TRC212411 [pii]
AID - 10.1002/trc2.12411 [doi]
PST - epublish
SO  - Alzheimers Dement (N Y). 2023 Jul 26;9(3):e12411. doi: 10.1002/trc2.12411. 
      eCollection 2023 Jul-Sep.