The Trial-Ready Cohort for Preclinical/Prodromal Alzheimer’s Disease (Trc-Pad) Project: An Overview

Aisen, Paul S.; Sperling, Reisa A.; Cummings, Jeffrey L.; Donohue, Michael C.; Langford, Oliver; Jimenez‐Maggiora, Gustavo; Rissman, Robert A.; Rafii, Michael S.; Walter, Sarah; Clanton, Taylor; Raman, Rema

doi:10.14283/jpad.2020.45

Cited by 24 publications

(26 citation statements)

References 14 publications

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“… 7 The shift from intervention to prevention studies, which rely on the timely assessment of genetic, neuroimaging, and biofluid biomarkers, further exacerbate these challenges. 8 , 9 Consequently, it is common for AD/ADRD trials to experience high site staff turnover and low-enrolling sites, potentially leading to data quality issues.…”

Section: Introductionmentioning

confidence: 99%

ATRI EDC: a novel cloud-native remote data capture system for large multicenter Alzheimer’s disease and Alzheimer’s disease-related dementias clinical trials

Jimenez‐Maggiora¹,

Bruschi²,

Qiu³

et al. 2022

JAMIA Open

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Objective The Alzheimer’s Therapeutic Research Institute (ATRI) developed a novel clinical data management system, the ATRI electronic data capture system (ATRI EDC), to address the complex regulatory, operational, and data requirements that arise in the conduct of multicenter Alzheimer’s disease and Alzheimer’s disease-related dementias (AD/ADRDs) clinical trials. We describe the system, its utility, and the broader implications for the field of clinical trials and clinical research informatics. Materials and Methods The ATRI EDC system was developed, tested, and validated using community-based agile software development methods and cloud-native single-page application design principles. It offers an increasing number of application modules, supports a high degree of study-specific configuration, and empowers study teams to effectively communicate and collaborate on the accurate and timely completion of study activities. Results To date, the ATRI EDC system supports 10 clinical studies, collecting study data for 4596 participants. Three case descriptions further illustrate how the system’s capabilities support diverse study-specific requirements. Discussion The ATRI EDC system has several advantages: its modular capabilities can accommodate rapidly evolving research designs and technologies; its community-based agile development approach and community-friendly licensing model encourage collaboration per the principles of open science; finally, with continued development and community building efforts, the system has the potential to facilitate the effective conduct of clinical studies beyond the field of AD/ADRD. Conclusion By effectively addressing the requirements of multicenter AD/ADRD studies, the ATRI EDC system supports ATRI’s scientific mission of rigorously testing new AD/ADRD therapies and facilitating the effective conduct of multicenter clinical studies.

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Section: Introductionmentioning

confidence: 99%

ATRI EDC: a novel cloud-native remote data capture system for large multicenter Alzheimer’s disease and Alzheimer’s disease-related dementias clinical trials

Jimenez‐Maggiora¹,

Bruschi²,

Qiu³

et al. 2022

JAMIA Open

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“…For example, a future study should make an online survey for website visitors or registrants asking how they learned of or were referred to the J-TRC study. However, it may not be easy to carry out within the current system, which was adopted from the Alzheimer Prevention Trials web study used in a similar preclinical AD study in the United States [ 25 ]. To use a data tracking system when sending emails to participants of other cognitive registries may be easier to implement.…”

Section: Discussionmentioning

confidence: 99%

“…Since 2019, we have been conducting the Japanese Trial-Ready Cohort (J-TRC) web study [ 24 ] (limited to Japanese domestic access only) ( Figure 1 ), as one such online screening registry of preclinical AD [ 25 ]. Within the first 9 months of its 2019 launch, the J-TRC web study has recruited more than 4000 online participants from all over Japan [ 26 ] via multiple modalities of promotions ( Figure 1 A), including press releases, newspaper advertisements, web advertisements ( Figure 1 B), and direct email invitations sent to another related registry.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Cost-effectiveness of Promotion Methods to Recruit Participants to an Online Screening Registry for Alzheimer Disease Prevention Trials: Observational Study

Sato¹,

Niimi²,

Ihara³

et al. 2021

J Med Internet Res

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Background Web-based screening may be suitable for identifying individuals with presymptomatic latent diseases for recruitment to clinical studies, as such people do not often visit hospitals in the presymptomatic stage. The promotion of such online screening studies is critical to their success, although it remains uncertain how the effectiveness of such promotion can differ, depending on the different promotion methods, domains of interest, or countries of implementation. Objective The Japanese Trial-Ready Cohort (J-TRC) web study is our ongoing online screening registry to identify individuals with presymptomatic Alzheimer disease (AD), aimed at facilitating the clinical trials for AD prevention. Within the first 9 months of its 2019 launch, the J-TRC web study recruited thousands of online participants via multiple methods of promotion, including press releases, newspaper advertisements, web advertisements, or direct email invitations. Here, we aimed to quantitatively evaluate efficacy and cost-effectiveness of each of these multimodal promotion methods. Methods We applied the vector-autoregression model to assess the degree of contribution of each type of promotion to the following target metrics: number of daily visitors to the J-TRC website, number of daily registrants to the J-TRC web study, daily rate of registration among visitors, daily rate of eligible participants among registrants, and median age of daily registrants. The average cost-effectiveness for each promotion method was also calculated using the total cost and the coefficients in the vector-autoregression model. Results During the first 9 months of the reviewed period from October 31, 2019 to June 17, 2020, there were 48,334 website visitors and 4429 registrations (9.16% of 48,334 visitors), of which 3081 (69.56%) were eligible registrations. Initial press release reports and newspaper advertisements had a marked effect on increasing the number of daily visitors and daily registrants. Web advertisements significantly contributed to the increase in daily visitors (P<.001) but not to the daily registrants, and it also lowered the rate of registrations and the median age of daily registrants. Website visitors from the direct email invitation sent to other cognitive registries seem to have registered with the highest reliability. The calculated average cost-effectiveness for the initial press release was US $24.60 per visitor and US $96.10 per registrant, while the calculated average cost-effectiveness for the newspaper advertisements was US $28.60 per visitor and US $227.90 per registrant. Conclusions Our multivariate time-series analysis showed that each promotion method had different features in their effect of recruiting participants to the J-TRC web study. Under the advertisement condition settings thus far, newspaper advertisements and initial press releases were the most effective promotion methods, with fair cost-effectiveness that was equivalent to earlier online studies. These results can provide important suggestions for future promotions for the recruitment of presymptomatic participants to AD clinical trials in Japan.

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“…In the last few years, several “trial-ready” cohort projects have been launched, the most relevant of which are EPAD [ 57 ] and TRC-PAD [ 58 ]. Such projects aim to recruit and screen participants in order to assemble deeply phenotyped cohorts which provide a pool of participants to clinical trials.…”

Section: Bhs Organizationmentioning

confidence: 99%

Brain Health Services: organization, structure, and challenges for implementation. A user manual for Brain Health Services—part 1 of 6

et al. 2021

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Dementia has a devastating impact on the quality of life of patients and families and comes with a huge cost to society. Dementia prevention is considered a public health priority by the World Health Organization. Delaying the onset of dementia by treating associated risk factors will bring huge individual and societal benefit. Empirical evidence suggests that, in higher-income countries, dementia incidence is decreasing as a result of healthier lifestyles. This observation supports the notion that preventing dementia is possible and that a certain degree of prevention is already in action. Further reduction of dementia incidence through deliberate prevention plans is needed to counteract its growing prevalence due to increasing life expectancy.An increasing number of individuals with normal cognitive performance seek help in the current memory clinics asking an evaluation of their dementia risk, preventive interventions, or interventions to ameliorate their cognitive performance. Consistent evidence suggests that some of these individuals are indeed at increased risk of dementia. This new health demand asks for a shift of target population, from patients with cognitive impairment to worried but cognitively unimpaired individuals. However, current memory clinics do not have the programs and protocols in place to deal with this new population.We envision the development of new services, henceforth called Brain Health Services, devoted to respond to demands from cognitively unimpaired individuals concerned about their risk of dementia. The missions of Brain Health Services will be (i) dementia risk profiling, (ii) dementia risk communication, (iii) dementia risk reduction, and (iv) cognitive enhancement. In this paper, we present the organizational and structural challenges associated with the set-up of Brain Health Services.

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The Trial-Ready Cohort for Preclinical/Prodromal Alzheimer’s Disease (Trc-Pad) Project: An Overview

Cited by 24 publications

References 14 publications

ATRI EDC: a novel cloud-native remote data capture system for large multicenter Alzheimer’s disease and Alzheimer’s disease-related dementias clinical trials

ATRI EDC: a novel cloud-native remote data capture system for large multicenter Alzheimer’s disease and Alzheimer’s disease-related dementias clinical trials

Efficacy and Cost-effectiveness of Promotion Methods to Recruit Participants to an Online Screening Registry for Alzheimer Disease Prevention Trials: Observational Study

Brain Health Services: organization, structure, and challenges for implementation. A user manual for Brain Health Services—part 1 of 6

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