OBJECTIVE:Alzheimer disease (AD) dementia clinical trials require 2 participants: a patient and a study partner. We assessed the prevalence of study partner types and how these types associate with patient-related outcome measures. METHODS: Retrospective analyses of 6 Alzheimer's disease cooperative study (ADCS) randomized clinical trials were conducted. Study partners were categorized as spouse, adult child, or other. Prevalence of study partner type and associations between study partner type and trial outcomes including study completion and placebo decline on the mini-mental state examination, the Alzheimer's disease assessment scale-cognitive subscale, the clinical dementia rating scale sum of the boxes score, and the ADCS-activities of daily living were examined. RESULTS:More participants (67%) enrolled with spouses than adult children (26%) or other study partners (7%). Participants with spouse partners had a lower dropout rate (25%) than those with adult child (32%) or other study partners (34%); only the difference vs. others was statistically significant. Participants with adult child and other partners randomized toplacebo performed worse at baseline than those with spouse partners on the ADCS-activities of daily living (p = 0.04), but were not different at 18 months. There were no differences at baseline for the mini-mental state examination, clinical dementia rating scale sum of the boxes score, or Alzheimer's disease assessment scale-cognitive subscale. In multivariate models of the rates of change over time among placebo participants, no differences among study partner groups reached statistical significance. CONCLUSIONS:Patients with nonspouse caregivers less frequently participate in AD dementia trials. Increased enrollment of AD patients with nonspouse caregivers may require additional recruitment and retention strategies.
RCT Entities:
OBJECTIVE:Alzheimer disease (AD) dementia clinical trials require 2 participants: a patient and a study partner. We assessed the prevalence of study partner types and how these types associate with patient-related outcome measures. METHODS: Retrospective analyses of 6 Alzheimer's disease cooperative study (ADCS) randomized clinical trials were conducted. Study partners were categorized as spouse, adult child, or other. Prevalence of study partner type and associations between study partner type and trial outcomes including study completion and placebo decline on the mini-mental state examination, the Alzheimer's disease assessment scale-cognitive subscale, the clinical dementia rating scale sum of the boxes score, and the ADCS-activities of daily living were examined. RESULTS: More participants (67%) enrolled with spouses than adult children (26%) or other study partners (7%). Participants with spouse partners had a lower dropout rate (25%) than those with adult child (32%) or other study partners (34%); only the difference vs. others was statistically significant. Participants with adult child and other partners randomized to placebo performed worse at baseline than those with spouse partners on the ADCS-activities of daily living (p = 0.04), but were not different at 18 months. There were no differences at baseline for the mini-mental state examination, clinical dementia rating scale sum of the boxes score, or Alzheimer's disease assessment scale-cognitive subscale. In multivariate models of the rates of change over time among placebo participants, no differences among study partner groups reached statistical significance. CONCLUSIONS:Patients with nonspouse caregivers less frequently participate in AD dementia trials. Increased enrollment of ADpatients with nonspouse caregivers may require additional recruitment and retention strategies.
Authors: M S Rafii; S Walsh; J T Little; K Behan; B Reynolds; C Ward; S Jin; R Thomas; P S Aisen Journal: Neurology Date: 2011-04-19 Impact factor: 9.910
Authors: Paul S Aisen; Lon S Schneider; Mary Sano; Ramon Diaz-Arrastia; Christopher H van Dyck; Myron F Weiner; Teodoro Bottiglieri; Shelia Jin; Karen T Stokes; Ronald G Thomas; Leon J Thal Journal: JAMA Date: 2008-10-15 Impact factor: 56.272
Authors: Warachal E Faison; Susan K Schultz; Jeroen Aerssens; Jennifer Alvidrez; Ravi Anand; Lindsay A Farrer; Lissy Jarvik; Jennifer Manly; Thomas McRae; Greer M Murphy; Jason T Olin; Darrel Regier; Mary Sano; Jacobo E Mintzer Journal: Int Psychogeriatr Date: 2007-04-23 Impact factor: 3.878
Authors: Stephanie Chiao; Howard J Rosen; Krista Nicolas; Lauren A Wendelken; Oscar Alcantar; Katherine P Rankin; Bruce Miller; Victor Valcour Journal: AIDS Res Hum Retroviruses Date: 2013-03-20 Impact factor: 2.205
Authors: Joshua D Grill; Jimmy Kwon; Merilee A Teylan; Aimee Pierce; Eric D Vidoni; Jeffrey M Burns; Allison Lindauer; Joseph Quinn; Jeff Kaye; Daniel L Gillen; Bin Nan Journal: Alzheimer Dis Assoc Disord Date: 2019 Oct-Dec Impact factor: 2.703
Authors: Shana D Stites; R Scott Turner; Jeanine Gill; Anna Gurian; Jason Karlawish; Joshua D Grill Journal: Clin Trials Date: 2021-01-10 Impact factor: 2.486
Authors: Jennifer L Watson; Laurie Ryan; Nina Silverberg; Vicky Cahan; Marie A Bernard Journal: Health Aff (Millwood) Date: 2014-04 Impact factor: 6.301
Authors: Thomas Polak; Martin J Herrmann; Laura D Müller; Julia B M Zeller; Andrea Katzorke; Matthias Fischer; Fabian Spielmann; Erik Weinmann; Leif Hommers; Martin Lauer; Andreas J Fallgatter; Jürgen Deckert Journal: J Neural Transm (Vienna) Date: 2017-09-01 Impact factor: 3.575