Recruitment of pre-dementia participants: main enrollment barriers in a longitudinal amyloid-PET study
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...
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| Format: | Article |
| Language: | English |
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BMC
2023-11-01
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| Series: | Alzheimer’s Research & Therapy |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13195-023-01332-4 |
| _version_ | 1827770727332315136 |
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| author | Ilse Bader Ilona Bader Isadora Lopes Alves David Vállez García Bruno Vellas Bruno Dubois Mercè Boada Marta Marquié Daniele Altomare Philip Scheltens Rik Vandenberghe Bernard Hanseeuw Michael Schöll Giovanni B. Frisoni Frank Jessen Agneta Nordberg Miia Kivipelto Craig W. Ritchie Oriol Grau-Rivera José Luis Molinuevo Lisa Ford Andrew Stephens Rossella Gismondi Juan Domingo Gispert Gill Farrar Frederik Barkhof Pieter Jelle Visser Lyduine E. Collij on behalf of the AMYPAD consortium |
| author_facet | Ilse Bader Ilona Bader Isadora Lopes Alves David Vállez García Bruno Vellas Bruno Dubois Mercè Boada Marta Marquié Daniele Altomare Philip Scheltens Rik Vandenberghe Bernard Hanseeuw Michael Schöll Giovanni B. Frisoni Frank Jessen Agneta Nordberg Miia Kivipelto Craig W. Ritchie Oriol Grau-Rivera José Luis Molinuevo Lisa Ford Andrew Stephens Rossella Gismondi Juan Domingo Gispert Gill Farrar Frederik Barkhof Pieter Jelle Visser Lyduine E. Collij on behalf of the AMYPAD consortium |
| author_sort | Ilse Bader |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-11T12:43:40Z |
| format | Article |
| id | doaj.art-53ca117657b04d869c1e2fc37d173899 |
| institution | Directory Open Access Journal |
| issn | 1758-9193 |
| language | English |
| last_indexed | 2024-03-11T12:43:40Z |
| publishDate | 2023-11-01 |
| publisher | BMC |
| record_format | Article |
| series | Alzheimer’s Research & Therapy |
| spelling | doaj.art-53ca117657b04d869c1e2fc37d1738992023-11-05T12:09:43ZengBMCAlzheimer’s Research & Therapy1758-91932023-11-0115111410.1186/s13195-023-01332-4Recruitment of pre-dementia participants: main enrollment barriers in a longitudinal amyloid-PET studyIlse Bader0Ilona Bader1Isadora Lopes Alves2David Vállez García3Bruno Vellas4Bruno Dubois5Mercè Boada6Marta Marquié7Daniele Altomare8Philip Scheltens9Rik Vandenberghe10Bernard Hanseeuw11Michael Schöll12Giovanni B. Frisoni13Frank Jessen14Agneta Nordberg15Miia Kivipelto16Craig W. Ritchie17Oriol Grau-Rivera18José Luis Molinuevo19Lisa Ford20Andrew Stephens21Rossella Gismondi22Juan Domingo Gispert23Gill Farrar24Frederik Barkhof25Pieter Jelle Visser26Lyduine E. Collij27on behalf of the AMYPAD consortiumAlzheimer Center Amsterdam, Neurology, Vrije Universiteit AmsterdamRadiology & Nuclear Medicine, Vrije Universiteit Amsterdam, Amsterdam UMC Location VUmcRadiology & Nuclear Medicine, Vrije Universiteit Amsterdam, Amsterdam UMC Location VUmcRadiology & Nuclear Medicine, Vrije Universiteit Amsterdam, Amsterdam UMC Location VUmcGérontopole of Toulouse, University Hospital of Toulouse (CHU-Toulouse)Institute of Memory and Alzheimer’s Disease (IM2A) and Brain Institute, Salpetriere Hospital, Sorbonne UniversityAce Alzheimer Center Barcelona, Universitat Internacional de Catalunya (UIC)Ace Alzheimer Center Barcelona, Universitat Internacional de Catalunya (UIC)Neurology Unit, Department of Clinical and Experimental Sciences, University of BresciaAlzheimer Center Amsterdam, Neurology, Vrije Universiteit AmsterdamLaboratory for Cognitive Neurology, Leuven Brain Institute, KU LeuvenInstitute of Neuroscience, Université Catholique de LouvainWallenberg Centre for Molecular and Translational Medicine, University of GothenburgLaboratory of Neuroimaging of Aging (LANVIE), University of GenevaGerman Center for Neurodegenerative Diseases (DZNE)Division of Clinical Geriatrics, Centre for Alzheimer Research, Department of Neurobiology, Care Sciences, and Society (NVS)Kuopio University HospitalUniversity of EdinburghBarcelonaβeta Brain Research Center (BBRC), Pasqual Maragall FoundationBarcelonaβeta Brain Research Center (BBRC), Pasqual Maragall FoundationJanssen Research and DevelopmentLife Molecular ImagingLife Molecular ImagingBarcelonaβeta Brain Research Center (BBRC), Pasqual Maragall FoundationGE Healthcare, Pharmaceutical DiagnosticsRadiology & Nuclear Medicine, Vrije Universiteit Amsterdam, Amsterdam UMC Location VUmcAlzheimer Center Amsterdam, Neurology, Vrije Universiteit AmsterdamRadiology & Nuclear Medicine, Vrije Universiteit Amsterdam, Amsterdam UMC Location VUmcAbstract 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.https://doi.org/10.1186/s13195-023-01332-4Alzheimer’s diseasePreclinicalRecruitmentEnrollment barriersAmyloid PETClinical trial |
| spellingShingle | Ilse Bader Ilona Bader Isadora Lopes Alves David Vállez García Bruno Vellas Bruno Dubois Mercè Boada Marta Marquié Daniele Altomare Philip Scheltens Rik Vandenberghe Bernard Hanseeuw Michael Schöll Giovanni B. Frisoni Frank Jessen Agneta Nordberg Miia Kivipelto Craig W. Ritchie Oriol Grau-Rivera José Luis Molinuevo Lisa Ford Andrew Stephens Rossella Gismondi Juan Domingo Gispert Gill Farrar Frederik Barkhof Pieter Jelle Visser Lyduine E. Collij on behalf of the AMYPAD consortium Recruitment of pre-dementia participants: main enrollment barriers in a longitudinal amyloid-PET study Alzheimer’s Research & Therapy Alzheimer’s disease Preclinical Recruitment Enrollment barriers Amyloid PET Clinical trial |
| title | Recruitment of pre-dementia participants: main enrollment barriers in a longitudinal amyloid-PET study |
| title_full | Recruitment of pre-dementia participants: main enrollment barriers in a longitudinal amyloid-PET study |
| title_fullStr | Recruitment of pre-dementia participants: main enrollment barriers in a longitudinal amyloid-PET study |
| title_full_unstemmed | Recruitment of pre-dementia participants: main enrollment barriers in a longitudinal amyloid-PET study |
| title_short | Recruitment of pre-dementia participants: main enrollment barriers in a longitudinal amyloid-PET study |
| title_sort | recruitment of pre dementia participants main enrollment barriers in a longitudinal amyloid pet study |
| topic | Alzheimer’s disease Preclinical Recruitment Enrollment barriers Amyloid PET Clinical trial |
| url | https://doi.org/10.1186/s13195-023-01332-4 |
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