Paul Aisen
A study team led by Paul Aisen, MD, director of USC’s Alzheimer’s Therapeutic Research Institute, recently published a set of papers describing a program called the Trial-Ready Cohort for Preclinical/prodromal Alzheimer’s Disease (TRC-PAD) project. The team reports on the progress of the program after three years, as well as its information technology infrastructure and the development of algorithms to identify participants likely to be eligible for clinical trials.
TRC-PAD 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 screening 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, more than 35,000 individuals have participated in the Webstudy; enrollment in the TRC is in its early stage.
The papers published by Aisen’s study team are all available through open access. To read them, click here:
- The Trial-Ready Cohort for Preclinical/Prodromal Alzheimer's Disease (TRC-PAD) Project: An Overview. Aisen et al.
- The Trial-Ready Cohort for Preclinical and Prodromal Alzheimer's Disease (TRC-PAD): Experience from the First 3 Years. Walter et al.
- Predicting Amyloid Burden to Accelerate Recruitment of Secondary Prevention Clinical Trials. Langford et al.
- TRC-PAD: Accelerating Recruitment of AD Clinical Trials through Innovative Information Technology. Jimenez-Maggiora et al.
- Recruitment into the Alzheimer Prevention Trials (APT) Webstudy for a Trial-Ready Cohort for Preclinical and Prodromal Alzheimer's Disease (TRC-PAD). Walter et al.
Please contact Sarah Walter waltersa@usc.edu if you would like to learn more about this innovative program.