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The purpose of the Trial Ready Cohort for the Prevention of Alzheimer’s Dementia (TRC-PAD) Platform is to find as many people as possible who were interested in participating in clinical trials aimed to reduce risk of developing Alzheimer’s dementia. TRC-PAD helped researchers enroll participants into these trials to quickly test new treatments. The Alzheimer Prevention Trial (APT) Webstudy is an important part of the TRC-PAD platform. Anyone over the age of 50 is invited to join the APT Webstudy and complete quarterly online memory tests. Over 59,000 individuals have enrolled. People who may have increased risk for memory loss caused by Alzheimer’s disease are then referred to studies taking place at a research center near them. The TRC-PAD in-person study served as a way to stay in touch with those that were still looking for the best clinical trial best for them. The in-person study visits were completed in April 2024. The APT Webstudy will continue and we hope to grow and expand this program over the coming years. TRC-PAD In-person ResultsOver 600 people were evaluated and 220 were enrolled in the in person TRC-PAD study. The study team is reviewing all of the results of the memory tests, blood tests and the MRI and PET scans. Much will be learned from all that participants contributed, and we will share updates on this page! Making it Easier to be a part of ResearchA key focus of the TRC-PAD project is how to make research easier to take part in. Most research studies are located in academic medical centers, where many people can’t go, either because of where they live, because of their work, or other responsibilities like caring. We designed the Alzheimer’s Prevention Trials (APT) Webstudy to make it easy to take part in research from your smart phone or tablet. We learned that many people are willing to sign up for an online study, with over 59,000 individuals now enrolled! Keeping people engaged in longitudinal online study is a challenge we continue to work to solve. We invited some people from the APT Webstudy to join a study that includes having a blood test at a community laboratory called AlzMatch. We learned that not only are people willing to sign up, but the blood tests that were collected were useful for connecting those individuals to a research study. AlzMatch participants have given 1,700 blood samples so far, and we are working to expand and invite more people soon! Other studies testing the best way to reach out to people from under-served communities and connect them to research have been done as part of the APT Webstudy. We will share more about what we have learned from those studies soon. The Promise of Digital Memory TestsWe have been testing whether memory tests done online can be just as good as the memory tests we do using experts in person. If we can show online tests are reliable, that means we can move more of our research studies out of the clinic and into your homes. Some online testing approaches that we are evaluating appear to be particularly sensitive to the earliest brain changes related to Alzheimer’s. We are working to expand these studies and are grateful to the participants that helped us test these new tools! Blood Tests to Improve ResearchAt present, the standard approach to measuring amyloid in brain requires a PET scan or a spinal tap. Both of which are expensive and burdensome. Blood tests are now showing great promise. TRC-PAD has increased our understanding of the accuracy of blood tests in predicting PET scan results and in tracking memory and function. Our hope and expectation is that blood tests of Alzheimer’s changes in brain will greatly improve our accuracy with research and clinical management Alzheimer’s. |
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ACTC SolutionACTC Member Sites were key partners throughout the TRC-PAD program. They provided input on the design of the study, as well as taking part in the various pilot studies testing ways to reach out to communities. Data will be shared for the TRC-PAD program as for other ACTC studies. |
Trial Ready Cohort for the Prevention of Alzheimer’s Dementia (TRC-PAD)
PIs:
Publications
The Trial-Ready Cohort for Preclinical/Prodromal Alzheimer’s Disease (TRC-PAD) Project: An Overview
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The Trial-Ready Cohort for Preclinical/prodromal Alzheimer’s Disease (TRC-PAD) project is a collaborative effort to establish an efficient mechanism for recruiting participants into very early stage Alzheimer’s disease trials. Clinically normal and mildly symptomatic individuals are followed longitudinally in a web-based component called the Alzheimer’s Prevention Trial Webstudy (APT Webstudy), with quarterly assessment of cognition and subjective concerns. The Webstudy data is used to predict the likelihood of brain amyloid elevation; individuals at relatively high risk are invited for in-person assessment in the TRC screeing phase, during which a cognitive battery is administered and Apolipoprotein E genotype is obtained followed by reassessment of risk of amyloid elevation. After an initial validation study, plasma amyloid peptide ratios will be included in this risk assessment. Based on this second risk calculation, individuals may have amyloid testing by PET scan or lumbar puncture, with those potentially eligible for trials followed in the TRC, while the rest are invited to remain in the APT Webstudy. To date, over 30,000 individuals have participated in the Webstudy; enrollment in the TRC is in its early stage.
Keywords: Alzheimer’s disease; Trial-Ready Cohort.
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TRC-PAD: Accelerating Recruitment of AD Clinical Trials through Innovative Information Technology
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Background: The Trial-Ready Cohort for Preclinical/Prodromal Alzheimer’s Disease (TRC-PAD) Informatics Platform (TRC-PAD IP) was developed to facilitate the efficient selection, recruitment, and assessment of study participants in support of the TRC-PAD program.
Objectives: Describe the innovative architecture, workflows, and components of the TRC-PAD IP.
Design: The TRC-PAD IP was conceived as a secure, scalable, multi-tiered information management platform designed to facilitate high-throughput, cost-effective selection, recruitment, and assessment of TRC-PAD study participants and to develop a learning algorithm to select amyloid-bearing participants to participate in trials of early-stage Alzheimer’s disease.
Setting: TRC-PAD participants were evaluated using both web-based and in-person assessments to predict their risk of amyloid biomarker abnormalities and eligibility for preclinical and prodromal clinical trials. Participant data were integrated across multiple stages to inform the prediction of amyloid biomarker elevation.
Participants: TRC-PAD participants were age 50 and above, with an interest in participating in Alzheimer’s research.
Measurements: TRC-PAD participants’ cognitive performance and subjective memory concerns were remotely assessed on a longitudinal basis to predict participant risk of biomarker abnormalities. Those participants determined to be at the highest risk were invited to an in-clinic screening visit for a full battery of clinical and cognitive assessments and amyloid biomarker confirmation using positron emission tomography (PET) or lumbar puncture (LP).
Results: The TRC-PAD IP supported growth in recruitment, screening, and enrollment of TRC-PAD participants by leveraging a secure, scalable, cost-effective cloud-based information technology architecture.
Conclusions: The TRC-PAD program and its underlying information management infrastructure, TRC-PAD IP, have demonstrated feasibility concerning the program aims. The flexible and modular design of the TRC-PAD IP will accommodate the introduction of emerging diagnostic technologies.
Keywords: Alzheimer’s; clinical trials; informatics; recruitment.
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Recruitment into the Alzheimer Prevention Trials (APT) Webstudy for a Trial-Ready Cohort for Preclinical and Prodromal Alzheimer’s Disease (TRC-PAD)
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Background: The Alzheimer Prevention Trials (APT) Webstudy is the first stage in establishing a Trial-ready Cohort for Preclinical and Prodromal Alzheimer’s disease (TRC-PAD). This paper describes recruitment approaches for the APT Webstudy.
Objectives: To remotely enroll a cohort of individuals into a web-based longitudinal observational study. Participants are followed quarterly with brief cognitive and functional assessments, and referred to Sites for in-clinic testing and biomarker confirmation prior to enrolling in the Trial-ready Cohort (TRC).
Design: Participants are referred to the APT Webstudy from existing registries of individuals interested in brain health and Alzheimer’s disease research, as well as through central and site recruitment efforts. The study team utilizes Urchin Tracking Modules (UTM) codes to better understand the impact of electronic recruitment methods.
Setting: A remotely enrolled online study.
Participants: Volunteers who are at least 50 years old and interested in Alzheimer’s research.
Measurements: Demographics and recruitment source of participant where measured by UTM.
Results: 30,650 participants consented to the APT Webstudy as of April 2020, with 69.7% resulting from referrals from online registries. Emails sent by the registry to participants were the most effective means of recruitment. Participants are distributed across the US, and the demographics of the APT Webstudy reflect the referral registries, with 73.1% female, 85.0% highly educated, and 92.5% Caucasian.
Conclusions: We have demonstrated the feasibility of enrolling a remote web-based study utilizing existing registries as a primary referral source. The next priority of the study team is to engage in recruitment initiatives that will improve the diversity of the cohort, towards the goal of clinical trials that better represent the US population.
Keywords: Alzheimer’s disease; Trial-ready cohort; online registry; preclinical; prevention; remote recruitment; web-based.
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The Trial-Ready Cohort for Preclinical and Prodromal Alzheimer’s Disease (TRC-PAD): Experience from the First 3 Years
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Background: The Trial-Ready Cohort for Preclinical and Prodromal Alzheimer’s disease (TRC-PAD) aims to accelerate enrollment for Alzheimer’s disease (AD) clinical trials by remotely identifying and tracking individuals who are at high risk for developing symptoms of AD, and referring these individuals to in-person cognitive and biomarker evaluation with the purpose of engaging them in clinical trials. A risk algorithm using statistical modeling to predict brain amyloidosis will be refined as TRC-PAD advances with a maturing data set.
Objectives: To provide a summary of the steps taken to build this Trial-Ready cohort (TRC) and share results of the first 3 years of enrollment into the program.
Design: Participants are remotely enrolled in the Alzheimer Prevention Trials (APT) Webstudy with quarterly assessments, and through an algorithm identified as potentially at high risk, referred to clinical sites for biomarker confirmation, and enrolled into the TRC.
Setting: Both an online study and in-clinic non-interventional cohort study.
Participants: APT Webstudy participants are aged 50 or older, with an interest in participation in AD therapeutic trials. TRC participants must have a study partner, stable medical condition, and elevated brain amyloid, as measured by amyloid positron emission tomography or cerebrospinal fluid analysis. Additional risk assessments include apolipoprotein E genotyping.
Measurements: In the APT Webstudy, participants complete the Cognitive Function Index and Cogstate Brief Battery. The TRC includes the Preclinical Alzheimer’s Cognitive Composite, comprised of the Free and Cued Selective Reminding Test, the Delayed Paragraph Recall score on the Logical Memory IIa test from the Wechsler Memory Scale, the Digit-Symbol Substitution test from the Wechsler Adult Intelligence Scale-Revised, and the Mini Mental State Examination total score (1).
Results: During the first 3 years of this program, the APT Webstudy has 30,650 consented participants, with 23 sites approved for in person screening, 112 participants have been referred for in-clinic screening visits with eighteen enrolled to the TRC. The majority of participants consented to APT Webstudy have a family history of AD (62%), identify as Caucasian (92.5%), have over twelve years of formal education (85%), and are women (73%). Follow up rates for the first quarterly assessment were 38.2% with 29.5% completing the follow up Cogstate Battery.
Conclusions: After successfully designing and implementing this program, the study team’s priority is to improve diversity of participants both in the APT Webstudy and TRC, to continue enrollment into the TRC to our target of 2,000, and to improve longitudinal retention, while beginning the process of referring TRC participants into clinical trials.
Keywords: Alzheimer’s disease; prevention; remote study; webstudy.
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