Outcome Measures for Dementia With Lewy Body Clinical Trials: A Review.
Journal
Alzheimer disease and associated disorders
ISSN: 1546-4156
Titre abrégé: Alzheimer Dis Assoc Disord
Pays: United States
ID NLM: 8704771
Informations de publication
Date de publication:
Historique:
received:
28
01
2021
accepted:
07
07
2021
pubmed:
17
8
2021
medline:
31
3
2022
entrez:
16
8
2021
Statut:
ppublish
Résumé
Dementia with Lewy bodies (DLB) is one of the most common degenerative dementias. Clinical trials for individuals with DLB are increasing. We aimed to identify commonly used outcome measures for trials in DLB. A pragmatic literature search of PubMed and clinicaltrials.gov identified interventional studies including populations with DLB. Studies were included if they enrolled participants with DLB and met the National Institutes of Health criteria for a clinical trial. Data were collected using standardized forms. Outcome measures were categorized according to core and supportive features of DLB. After de-duplication, 58 trials were identified. The most common cognitive outcome measures were the Mini Mental State Examination (n=24) and Cognitive Drug Research computerized Assessment System (n=5). The Clinician's Assessment of Fluctuations was the most commonly used measure for fluctuations (n=4). Over half of studies used the Neuropsychiatric Inventory to assess behavioral symptoms (n=31). The Unified Parkinson's Disease Rating Scale was frequently used for motor assessment (n=23). Clinical trial outcomes used in DLB are rarely validated in this population and some lack face validity. There is a need to validate existing scales in DLB and develop DLB-specific outcome measures.
Sections du résumé
BACKGROUND
Dementia with Lewy bodies (DLB) is one of the most common degenerative dementias. Clinical trials for individuals with DLB are increasing. We aimed to identify commonly used outcome measures for trials in DLB.
METHODS
A pragmatic literature search of PubMed and clinicaltrials.gov identified interventional studies including populations with DLB. Studies were included if they enrolled participants with DLB and met the National Institutes of Health criteria for a clinical trial. Data were collected using standardized forms. Outcome measures were categorized according to core and supportive features of DLB.
RESULTS
After de-duplication, 58 trials were identified. The most common cognitive outcome measures were the Mini Mental State Examination (n=24) and Cognitive Drug Research computerized Assessment System (n=5). The Clinician's Assessment of Fluctuations was the most commonly used measure for fluctuations (n=4). Over half of studies used the Neuropsychiatric Inventory to assess behavioral symptoms (n=31). The Unified Parkinson's Disease Rating Scale was frequently used for motor assessment (n=23).
CONCLUSIONS AND RELEVANCE
Clinical trial outcomes used in DLB are rarely validated in this population and some lack face validity. There is a need to validate existing scales in DLB and develop DLB-specific outcome measures.
Identifiants
pubmed: 34393189
doi: 10.1097/WAD.0000000000000473
pii: 00002093-202201000-00010
pmc: PMC8847491
mid: NIHMS1723643
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
64-72Subventions
Organisme : AHRQ HHS
ID : K08 HS024159
Pays : United States
Informations de copyright
Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.
Déclaration de conflit d'intérêts
B.P. has received a training grant from the American Brain Foundation. She received compensation for consultation with Medtronic. D.K. received research support from Acadia, Alector, Axovant, and EIP Pharma, as well as NIH, AHRQ, the National Football League, and the Bryan Family Foundation. He has served as a consultant for Axovant and VeraSci, and receives royalties from UptoDate. B.F.B. has served as an investigator for clinical trials sponsored by Biogen, Alector, and EIP Pharma. He receives royalties from the publication of a book entitled Behavioral Neurology of Dementia (Cambridge Medicine, 2009, 2017). He serves on the Scientific Advisory Board of the Tau Consortium. He receives research support from the NIH, the Mayo Clinic Dorothy and Harry T. Mangurian Jr. Lewy Body Dementia Program, the Little Family Foundation, and the Turner Family Foundation. A.T. is an employee of the Lewy Body Dementia Association. M.J.A. is supported by an ARHQ K08 career development award (K08HS24159); receives compensation from the AAN for work as an evidence-based medicine methodology consultant and is on the level of evidence Editorial Board for Neurology and related publications (uncompensated); receives publishing royalties for Parkinson’s Disease: Improving Patient Care (Oxford University Press, 2014); and has received honoraria from Medscape CME. D.J.I. declares no conflicts of interest.
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