PMID- 38427487
OWN - NLM
STAT- MEDLINE
DCOM- 20240325
LR  - 20240427
IS  - 1875-8908 (Electronic)
IS  - 1387-2877 (Print)
IS  - 1387-2877 (Linking)
VI  - 98
IP  - 2
DP  - 2024
TI  - Study Partner Type and Adverse Event Reporting in Mild-to-Moderate Alzheimer's 
      Disease Clinical Trials.
PG  - 729-738
LID - 10.3233/JAD-231283 [doi]
AB  - BACKGROUND: In randomized clinical trials (RCTs), monitoring adverse events (AEs) 
      and serious AEs (SAEs) is critical. All Alzheimer's disease (AD) RCTs require 
      participants to enroll with a study partner. OBJECTIVE: We examined AE reporting 
      rates in mild-to-moderate AD trials and their associations with study partner 
      type. METHODS: We estimated AE reporting rates using placebo data from seven 
      independent RCTs conducted by the Alzheimer's Disease Cooperative Study. We 
      assessed the heterogeneity of reporting rates as a function of visits using 
      generalized estimating equations. In the primary analysis, we tested the 
      hypotheses that the rates of reporting differed by study partner type and time 
      they spent with the participant weekly using Poisson regression with robust 
      variance estimation. In all regression models, log-transformed total patient 
      years was included. RESULTS: The estimated reporting rates were 2.83 (95% CI: 
      2.66, 3.02), 1.18 (95% CI: 1.09, 1.28), 0.23 (95% CI: 0.19, 0.27), and 0.28 (95% 
      CI: 0.24, 0.33) events per participant year for grade 1-3 AEs and SAEs, 
      respectively. We estimated that greater number of visits per year was associated 
      with increased reporting for grade 1-2 AEs and SAEs. We did not find evidence to 
      suggest that AE reporting differed by study partner type or by time the study 
      partner spent with the participant. CONCLUSIONS: Study partner type and time the 
      study partner spent with the participant did not appear to impact AE reporting. 
      Estimated reporting rates may be useful to evaluate safety in future studies, 
      particularly those with no control arm and similar visit frequencies.
FAU - Lu, Thuy V
AU  - Lu TV
AD  - Department of Statistics, University of California, Irvine, CA, USA.
AD  - Institute for Memory Impairments and Neurological Disorders, University of 
      California, Irvine, CA, USA.
FAU - Grill, Joshua D
AU  - Grill JD
AD  - Institute for Memory Impairments and Neurological Disorders, University of 
      California, Irvine, CA, USA.
AD  - Department of Neurobiology and Behavior, University of California, Irvine, CA, 
      USA.
AD  - Department of Psychiatry and Human Behavior, University of California, Irvine, 
      CA, USA.
FAU - Gillen, Daniel L
AU  - Gillen DL
AD  - Department of Statistics, University of California, Irvine, CA, USA.
AD  - Institute for Memory Impairments and Neurological Disorders, University of 
      California, Irvine, CA, USA.
AD  - Department of Epidemiology and Biostatistics, University of California, Irvine, 
      CA, USA.
AD  - Department of Population Health and Disease Prevention, University of California, 
      Irvine, CA, USA.
CN  - Alzheimer's Disease Cooperative Study
LA  - eng
GR  - P30 AG066519/AG/NIA NIH HHS/United States
GR  - R01 AG083926/AG/NIA NIH HHS/United States
GR  - RF1 AG059407/AG/NIA NIH HHS/United States
GR  - U19 AG010483/AG/NIA NIH HHS/United States
PT  - Journal Article
PL  - Netherlands
TA  - J Alzheimers Dis
JT  - Journal of Alzheimer's disease : JAD
JID - 9814863
SB  - IM
MH  - Humans
MH  - *Alzheimer Disease
PMC - PMC10977362
OTO - NOTNLM
OT  - Adverse event
OT  - Alzheimer's disease
OT  - clinical trials
OT  - study partner
COIS- JDG discloses research support from the National Institute of Health, Alzheimer's 
      Association, Bright Focus Foundation, Eli Lilly, Biogen, and Eisai. He has 
      provided consulting to Site Rx and served on the Editorial Board of Alzheimer's & 
      Dementia journal. JDG is an Editorial Board Member of this journal but was not 
      involved in the peer-review process of this article nor had access to any 
      information regarding its peer-review. DLG and TVL declare that they have no 
      conflicting interests.
EDAT- 2024/03/01 18:43
MHDA- 2024/03/25 06:42
PMCR- 2024/03/28
CRDT- 2024/03/01 12:23
PHST- 2024/03/25 06:42 [medline]
PHST- 2024/03/01 18:43 [pubmed]
PHST- 2024/03/01 12:23 [entrez]
PHST- 2024/03/28 00:00 [pmc-release]
AID - JAD231283 [pii]
AID - 10.3233/JAD-231283 [doi]
PST - ppublish
SO  - J Alzheimers Dis. 2024;98(2):729-738. doi: 10.3233/JAD-231283.