ACTC at Clinical Trials on Alzheimer’s Disease 2023
The following itinerary lists some of the sessions where ACTC members are either presenting or have co-authored the presentation. We hope this highlights and provides insight into some of the work being done by ACTC members and collaborators. We look forward to connecting with you all and hope to see you there! ACTC at CTAD2023_HighlightsGuide
ACTC Adds Three New Member Sites!
We are pleased to announce that ACTC has added three new member sites: University of Wisconsin, Vanderbilt University, and Eastern Virginia Medical Center. Please refer to our ‘Sites’ page here to see a map of our growing network and more information about the site’s PIs: https://www.actcinfo.org/member-sites/.
ACTC is Adding New Member Sites – Request for Applications!
The Alzheimer’s Clinical Trials Consortium (ACTC) seeks applications to join the network from research centers capable of conducting high integrity clinical trials in Alzheimer’s disease (AD) and Alzheimer’s disease related dementias (ADRD), with an emphasis on enrolling participants who are representative of the greater disease suffering population. The deadline for this application is May 30, 2023. ACTC’s mission is to facilitate state-of the art AD/ADRD interventional trials by providing an optimal infrastructure, utilizing centralized resources, and leveraging shared expertise. What type of research sites are invited to apply? ACTC is looking for two categories of research sites:
- Category A – Member Sites: Sites with established track record of conducting AD/ADRD trials.
- Category B – Developmental/Exploratory Trial Sites: Sites with less experience in the conduct of AD/ADRD clinical trials interested in mentored opportunities through the consortium to establish rigorous programs in the conduct of these studies. Of particular interest for this category are sites with the leadership, staff, access, and relationships with communities who are typically under-represented in AD/ADRD trials.
- Annual infrastructure funding covers effort for the following four positions: 5% of the Principal Investigator (PI), 20% of a Co-PI (ideally an early or mid-career investigator), 50% of a Site Liaison, and 100% of a community outreach coordinator.
- Site PIs are voting members of the ACTC Steering committee, approve any new ACTC Study proposals, provide input and guidance on study design and conduct, and may even co-lead multisite trials.
- Site staff have opportunity and access to an array of resources and committee involvement opportunities, intended to enhance the quality of trial conduct for individual investigators, sites, and the network overall.
- ACTC developmental/exploratory sites receive annual infrastructure cost to cover effort for the following four positions: 5% PI, 5% co-PI, 25% site liaison, 100% community outreach coordinator. This effort will support the planning and establishment of the infrastructure to become an ACTC member site.
- Developmental/exploratory sites will receive formal mentoring from an ACTC mentoring committee, with the goal of building capacity to support and eventually participate in ACTC trials.
- Site staff have opportunity and access to an array of resources and committee involvement opportunities, intended to enhance the quality of trial conduct for individual investigators, sites, and the network overall.
- ACTC Member Sites must agree to a Master Clinical Trial Agreement and to use the single, central Institutional Review Board (IRB). Fixed trial budgets are utilized for ACTC studies across all sites. Budgets do have input from a committee.
- ACTC site personnel (member and developmental/exploratory sites) are expected to participate in three ACTC steering committee meetings each year to discuss ongoing and consider new consortium studies and initiatives.
- Member site funded personnel are also expected participate in ACTC committees, initiatives, and trials and actively engage in the consortium activities. Sites must meet minimum performance requirements to maintain financial support. Minimum performance requirements are established with input from the ACTC steering committee members and the ACTC site metrics and budget committee.
- Submit your application using this link: https://redcap.link/actc-new-sites. You will upload CVs for your application PI and co-PI and can save and return to the application if needed.
- Applications are due May 30, 2023. Applications are reviewed in June and selection will take place late June 2023, with subcontracts sent during July 2023.
- Studies we are conducting: https://www.actcinfo.org/projects/
- See our current member sites: https://www.actcinfo.org/member-sites/
- Contact ACTC Program Administrator via email: waltersa@usc.edu, or by phone: 858-531-7089.
Internal Ethics Committee holds debate to inform regulatory review of Alzheimer’s drugs
Committee of the Alzheimer’s Clinical Trials Consortium (ACTC). “Science precedes by open debate and discussion,” said Jason Karlawish, MD, who moderated the event and is co-chair of the ACTC Internal Ethics Committee. The goal of the debate was to inform the Alzheimer’s field about regulatory approaches that have been applied in the reviews of the drugs aducanumab, lecanemab, and donanemab. At the conclusion of the debate, audience members voted “yes” or “no” in response to the question “PET is a suitable surrogate endpoint?” Only 25% of audience members voted “yes.”
Are we there yet with PET? – Internal Ethics Committee Webinar Invitation
Jason Karlawish, MD, and Joshua Grill, PhD, co-chairs of the Internal Ethics Committee of the Alzheimer’s Clinical Trial Consortium (ACTC, NIA U24 AG057437), together with the committee members invite you to “Are we there yet with PET?” a virtual debate over amyloid PET as a surrogate endpoint for clinically meaningful outcomes. The goal of this debate is to inform the Alzheimer’s field about regulatory approaches that have been applied in the reviews of aducanumab, lecanemab and donanemab. This discussion will be recorded. 4 p.m. February 23, 2023 | Click here to register Topics:
- “The law and regulation for surrogate endpoints with attention to history and changing interpretations” — Holly Fernandez Lynch, JD, MBe (University of Pennsylvania)
- “The case for beta-amyloid as measured by PET” — Dennis Selkoe, MD (Harvard University)
- “The case against beta-amyloid as measured by PET” — Chris van Dyck, MD (Yale University)