Bader, I;
Bader, I;
Lopes Alves, I;
Vállez García, D;
Vellas, B;
Dubois, B;
Boada, M;
... Collij, LE; + view all
(2023)
Recruitment of pre-dementia participants: main enrollment barriers in a longitudinal amyloid-PET study.
Alzheimer's Research and Therapy
, 15
(1)
, Article 189. 10.1186/s13195-023-01332-4.
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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 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.
| Type: | Article |
|---|---|
| Title: | Recruitment of pre-dementia participants: main enrollment barriers in a longitudinal amyloid-PET study |
| Location: | England |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1186/s13195-023-01332-4 |
| Publisher version: | https://doi.org/10.1186/s13195-023-01332-4 |
| Language: | English |
| Additional information: | This work is licensed under a Creative Commons Attribution 4.0 International License. The images or other third-party material in this article are included in the Creative Commons license, unless indicated otherwise in the credit line; if the material is not included under the Creative Commons license, users will need to obtain permission from the license holder to reproduce the material. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/ |
| Keywords: | Alzheimer’s disease, Amyloid PET, Clinical trial, Enrollment barriers, Preclinical, Recruitment, Humans, Alzheimer Disease, Amyloid, Amyloid beta-Peptides, Amyloidogenic Proteins, Cognition, Cognitive Dysfunction, Longitudinal Studies, Positron-Emission Tomography, Male, Female |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > UCL Queen Square Institute of Neurology UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > UCL Queen Square Institute of Neurology > Brain Repair and Rehabilitation |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10181799 |
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