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Recruitment of pre-dementia participants : main enrollment barriers in a longitudinal amyloid-PET study

Bader, Ilse ; Bader, Ilona ; Lopes Alves, Isadora ; Vállez García, David ; Vellas, Bruno ; Dubois, Bruno ; Boada, Mercè ; Marquié, Marta ; Altomare, Daniele and Scheltens, Philip , et al. (2023) In Alzheimer's Research and Therapy 15(1).
Abstract

Background: The mismatch between the limited availability versus the high demand of participants who are in the pre-dementia phase of Alzheimer’s disease (AD) is a bottleneck for clinical studies in AD. Nevertheless, potential enrollment barriers in the pre-dementia population are relatively under-reported. In a large European longitudinal biomarker study (the AMYPAD-PNHS), we investigated main enrollment barriers in individuals with no or mild symptoms recruited from research and clinical parent cohorts (PCs) of ongoing observational studies. Methods: Logistic regression was used to predict study refusal based on sex, age, education, global cognition (MMSE), family history of dementia, and number of prior study visits. Study refusal... (More)

Background: The mismatch between the limited availability versus the high demand of participants who are in the pre-dementia phase of Alzheimer’s disease (AD) is a bottleneck for clinical studies in AD. Nevertheless, potential enrollment barriers in the pre-dementia population are relatively under-reported. In a large European longitudinal biomarker study (the AMYPAD-PNHS), we investigated main enrollment barriers in individuals with no or mild symptoms recruited from research and clinical parent cohorts (PCs) of ongoing observational studies. Methods: Logistic regression was used to predict study refusal based on sex, age, education, global cognition (MMSE), family history of dementia, and number of prior study visits. Study refusal rates and categorized enrollment barriers were compared between PCs using chi-squared tests. Results: 535/1856 (28.8%) of the participants recruited from ongoing studies declined participation in the AMYPAD-PNHS. Only for participants recruited from clinical PCs (n = 243), a higher MMSE-score (β = − 0.22, OR = 0.80, p <.05), more prior study visits (β = − 0.93, OR = 0.40, p <.001), and positive family history of dementia (β = 2.08, OR = 8.02, p <.01) resulted in lower odds on study refusal. General study burden was the main enrollment barrier (36.1%), followed by amyloid-PET related burden (PCresearch = 27.4%, PCclinical = 9.0%, X 2 = 10.56, p =.001), and loss of research interest (PCclinical = 46.3%, PCresearch = 16.5%, X 2 = 32.34, p <.001). Conclusions: The enrollment rate for the AMYPAD-PNHS was relatively high, suggesting an advantage of recruitment via ongoing studies. In this observational cohort, study burden reduction and tailored strategies may potentially improve participant enrollment into trial readiness cohorts such as for phase-3 early anti-amyloid intervention trials. The AMYPAD-PNHS (EudraCT: 2018–002277-22) was approved by the ethical review board of the VU Medical Center (VUmc) as the Sponsor site and in every affiliated site.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Alzheimer’s disease, Amyloid PET, Clinical trial, Enrollment barriers, Preclinical, Recruitment
in
Alzheimer's Research and Therapy
volume
15
issue
1
article number
189
publisher
BioMed Central (BMC)
external identifiers
  • pmid:37919783
  • scopus:85175698378
ISSN
1758-9193
DOI
10.1186/s13195-023-01332-4
language
English
LU publication?
yes
id
14c93959-39fc-4651-8d88-7561d6db1ffe
date added to LUP
2023-11-23 11:28:18
date last changed
2024-04-20 14:54:47
@article{14c93959-39fc-4651-8d88-7561d6db1ffe,
  abstract     = {{<p>Background: The mismatch between the limited availability versus the high demand of participants who are in the pre-dementia phase of Alzheimer’s disease (AD) is a bottleneck for clinical studies in AD. Nevertheless, potential enrollment barriers in the pre-dementia population are relatively under-reported. In a large European longitudinal biomarker study (the AMYPAD-PNHS), we investigated main enrollment barriers in individuals with no or mild symptoms recruited from research and clinical parent cohorts (PCs) of ongoing observational studies. Methods: Logistic regression was used to predict study refusal based on sex, age, education, global cognition (MMSE), family history of dementia, and number of prior study visits. Study refusal rates and categorized enrollment barriers were compared between PCs using chi-squared tests. Results: 535/1856 (28.8%) of the participants recruited from ongoing studies declined participation in the AMYPAD-PNHS. Only for participants recruited from clinical PCs (n = 243), a higher MMSE-score (β = − 0.22, OR = 0.80, p &lt;.05), more prior study visits (β = − 0.93, OR = 0.40, p &lt;.001), and positive family history of dementia (β = 2.08, OR = 8.02, p &lt;.01) resulted in lower odds on study refusal. General study burden was the main enrollment barrier (36.1%), followed by amyloid-PET related burden (PC<sub>research</sub> = 27.4%, PC<sub>clinical</sub> = 9.0%, X <sup> 2</sup> = 10.56, p =.001), and loss of research interest (PC<sub>clinical</sub> = 46.3%, PC<sub>research</sub> = 16.5%, X <sup> 2</sup> = 32.34, p &lt;.001). Conclusions: The enrollment rate for the AMYPAD-PNHS was relatively high, suggesting an advantage of recruitment via ongoing studies. In this observational cohort, study burden reduction and tailored strategies may potentially improve participant enrollment into trial readiness cohorts such as for phase-3 early anti-amyloid intervention trials. The AMYPAD-PNHS (EudraCT: 2018–002277-22) was approved by the ethical review board of the VU Medical Center (VUmc) as the Sponsor site and in every affiliated site.</p>}},
  author       = {{Bader, Ilse and Bader, Ilona and Lopes Alves, Isadora and Vállez García, David and Vellas, Bruno and Dubois, Bruno and Boada, Mercè and Marquié, Marta and Altomare, Daniele and Scheltens, Philip and Vandenberghe, Rik and Hanseeuw, Bernard and Schöll, Michael and Frisoni, Giovanni B. and Jessen, Frank and Nordberg, Agneta and Kivipelto, Miia and Ritchie, Craig W. and Grau-Rivera, Oriol and Molinuevo, José Luis and Ford, Lisa and Stephens, Andrew and Gismondi, Rossella and Gispert, Juan Domingo and Farrar, Gill and Barkhof, Frederik and Visser, Pieter Jelle and Collij, Lyduine E.}},
  issn         = {{1758-9193}},
  keywords     = {{Alzheimer’s disease; Amyloid PET; Clinical trial; Enrollment barriers; Preclinical; Recruitment}},
  language     = {{eng}},
  number       = {{1}},
  publisher    = {{BioMed Central (BMC)}},
  series       = {{Alzheimer's Research and Therapy}},
  title        = {{Recruitment of pre-dementia participants : main enrollment barriers in a longitudinal amyloid-PET study}},
  url          = {{http://dx.doi.org/10.1186/s13195-023-01332-4}},
  doi          = {{10.1186/s13195-023-01332-4}},
  volume       = {{15}},
  year         = {{2023}},
}