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

被引：2

作者：

Bader, Ilse ^{[1
,2
]}

Bader, Ilona ^{[3
,4
]}

Lopes Alves, Isadora ^{[3
,4
,5
]}

Vallez Garcia, David ^{[3
,4
]}

Vellas, Bruno ^{[6
,7
]}

Dubois, Bruno ^{[8
,9
]}

Boada, Merce ^{[10
,11
]}

Marquie, Marta ^{[10
,11
]}

Altomare, Daniele ^{[12
]}

Scheltens, Philip ^{[1
,2
]}

Vandenberghe, Rik ^{[13
]}

Hanseeuw, Bernard ^{[14
,15
,16
,17
]}

Scholl, Michael ^{[18
,19
,20
]}

Frisoni, Giovanni B. ^{[21
,22
]}

Jessen, Frank ^{[23
]}

Nordberg, Agneta ^{[24
,25
,26
]}

Kivipelto, Miia ^{[27
,28
,29
]}

Ritchie, Craig W. ^{[30
]}

Grau-Rivera, Oriol ^{[31
]}

Molinuevo, Jose Luis ^{[31
,32
]}

Ford, Lisa ^{[33
]}

Stephens, Andrew ^{[34
]}

Gismondi, Rossella ^{[34
]}

Gispert, Juan Domingo ^{[31
]}

Farrar, Gill ^{[35
]}

Barkhof, Frederik ^{[3
,4
,36
]}

Visser, Pieter Jelle ^{[1
,2
,37
]}

Collij, Lyduine E. ^{[3
,4
,38
]}

机构：

[1] Vrije Univ Amsterdam, Alzheimer Ctr Amsterdam, Neurol, Boelelaan 1118, NL-1081 HZ Amsterdam, Netherlands

[2] Amsterdam Neurosci, Neurodegenerat, NL-1081 HV Amsterdam, Netherlands

[3] Vrije Univ Amsterdam, Radiol & Nucl Med, Amsterdam UMC locat VUmc, NL-1081 HZ Amsterdam, Netherlands

[4] Amsterdam Neurosci, Brain Imaging, NL-1081 HV Amsterdam, Netherlands

[5] Brain Res Ctr, NL-1081 GN Amsterdam, Netherlands

[6] Univ Hosp Toulouse, Gerontopole Toulouse, CHU Toulouse, F-31300 Toulouse, France

[7] Univ Toulouse III, INSERM, UMR 1027, F-31062 Toulouse, France

[8] Sorbonne Univ, Salpetriere Hosp, Inst Memory & Alzheimers Dis IM2A, F-75013 Paris, France

[9] Sorbonne Univ, Salpetriere Hosp, Brain Inst, F-75013 Paris, France

[10] Univ Int Catalunya UIC, Ace Alzheimer Ctr Barcelona, Barcelona 08028, Spain

[11] Inst Salud Carlos III, Networking Res Ctr Neurodegenerat Dis CIBERNED, Madrid 28029, Spain

[12] Univ Brescia, Dept Clin & Expt Sci, Neurol Unit, I-25123 Brescia, Italy

[13] Katholieke Univ Leuven, Leuven Brain Inst, Lab Cognit Neurol, B-3001 Louvain, Belgium

[14] Catholic Univ Louvain, Inst Neurosci, B-1200 Brussels, Belgium

[15] Clin Univ St Luc, Dept Neurol, B-1200 Brussels, Belgium

[16] Massachusetts Gen Hosp, Gordon Ctr Med Imaging, Dept Radiol, Boston, MA 02155 USA

[17] WEL Res Inst, WELBIO Dept, Ave Pasteur 6, B-1300 Wavre, Belgium

[18] Univ Gothenburg, Wallenberg Ctr Mol & Translat Med, S-40530 Gothenburg, Sweden

[19] Univ Gothenburg, Inst Neurosci & Physiol, Sahlgrenska Acad, S-40530 Gothenburg, Sweden

[20] UCL, Queen Inst Neurol, Dementia Res Ctr, London WC1N 3BG, England

[21] Univ Geneva, Lab Neuroimaging Aging LANVIE, CH-1205 Geneva, Switzerland

[22] Geneva Univ Hosp, Geneva Memory Ctr, CH-1205 Geneva, Switzerland

[23] German Ctr Neurodegenerat Dis DZNE, D-53127 Bonn, Germany

[24] Karolinska Inst, Ctr Alzheimer Res, Dept Neurobiol Care Sci & Soc NVS, Div Clin Geriatr, S-17177 Stockholm, Sweden

[25] Karolinska Univ Hosp, Theme Inflammat, S-17177 Stockholm, Sweden

[26] Karolinska Univ Hosp, Theme Aging, S-17177 Stockholm, Sweden

[27] Kuopio Univ Hosp, Kuopio 70210, Finland

[28] Karolinska Inst, Ctr Alzheimer Res, Dept Neurobiol Care Sci & Soc NVS, Div Clin Geriatr, S-17177 Stockholm, Sweden

[29] Imperial Coll London, London SW7 2AZ, England

[30] Univ Edinburgh, Edinburgh EH8 9YL, Scotland

[31] Pasqual Maragall Fdn, BarcelonaBeta Brain Res Ctr BBRC, Barcelona 08005, Spain

[32] H Lundbeck A S, DK-2500 Copenhagen, Denmark

[33] Janssen Res & Dev, Titusville, NJ 08560 USA

[34] Life Mol Imaging, D-13353 Berlin, Germany

[35] GE Healthcare, Pharmaceut Diagnost, Amersham HP7 9LL, England

[36] UCL, Inst Neurol & Healthcare Engn, London WC1N 3BG, England

[37] Maastricht Univ, Alzheimer Ctr Limburg, Sch Mental Hlth & Neurosci, Dept Psychiat & Neuropsychol, NL-6229 ER Maastricht, Netherlands

[38] Lund Univ, Dept Clin Sci, Clin Memory Res Unit, S-22100 Malmo, Sweden

来源：

ALZHEIMERS RESEARCH & THERAPY | 2023年 / 15卷 / 01期

基金：

欧盟地平线“2020”;

关键词：

Alzheimer's disease; Preclinical; Recruitment; Enrollment barriers; Amyloid PET; Clinical trial; ALZHEIMERS-DISEASE; CLINICAL-TRIALS; RETENTION; STRATEGIES; DISCLOSURE; FRAMEWORK; PATIENT; MEMORY;

D O I：

10.1186/s13195-023-01332-4

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

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 (beta = - 0.22, OR = 0.80, p < .05), more prior study visits (beta = - 0.93, OR = 0.40, p < .001), and positive family history of dementia (beta = 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.

引用

页数：14

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