TY - JOUR
T1 - Recruitment of pre-dementia participants
T2 - main enrollment barriers in a longitudinal amyloid-PET study
AU - Bader, Ilse
AU - Bader, Ilona
AU - Lopes Alves, Isadora
AU - Vállez García, David
AU - Vellas, Bruno
AU - Dubois, Bruno
AU - Boada, Mercè
AU - Marquié, Marta
AU - Altomare, Daniele
AU - Scheltens, Philip
AU - Vandenberghe, Rik
AU - Hanseeuw, Bernard
AU - Schöll, Michael
AU - Frisoni, Giovanni B.
AU - Jessen, Frank
AU - Nordberg, Agneta
AU - Kivipelto, Miia
AU - Ritchie, Craig W.
AU - Grau-Rivera, Oriol
AU - Molinuevo, José Luis
AU - Ford, Lisa
AU - Stephens, Andrew
AU - Gismondi, Rossella
AU - Gispert, Juan Domingo
AU - Farrar, Gill
AU - Barkhof, Frederik
AU - Visser, Pieter Jelle
AU - Collij, Lyduine E.
N1 - Funding Information: The project leading to this paper has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 115952. This Joint Undertaking receives the support from the European Union’s Horizon 2020 research and innovation program and EFPIA. This communication reflects the views of the authors and neither IMI nor the European Union and EFPIA are liable for any use that may be made of the information contained herein. Publisher Copyright: © 2023, The Author(s).
PY - 2023/12/1
Y1 - 2023/12/1
N2 - 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 (PC research = 27.4%, PC clinical = 9.0%, X 2 = 10.56, p =.001), and loss of research interest (PC clinical = 46.3%, PC research = 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.
AB - 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 (PC research = 27.4%, PC clinical = 9.0%, X 2 = 10.56, p =.001), and loss of research interest (PC clinical = 46.3%, PC research = 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.
KW - Alzheimer’s disease
KW - Amyloid PET
KW - Clinical trial
KW - Enrollment barriers
KW - Preclinical
KW - Recruitment
UR - http://www.scopus.com/inward/record.url?scp=85175698378&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s13195-023-01332-4
DO - https://doi.org/10.1186/s13195-023-01332-4
M3 - Article
C2 - 37919783
SN - 1758-9193
VL - 15
JO - Alzheimer's Research and Therapy
JF - Alzheimer's Research and Therapy
IS - 1
M1 - 189
ER -