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Units

Our dedicated Units are the driving force behind the day-to-day conduct of the ACTC and oversee the development and execution of our clinical trials.
Administration Unit
Lead: Jeremy Pizzola
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Alzheimer’s Clinical Trials Education, Engagement, Access, and Accountability (ACT-E2A2) Unit
Co-Leads: Rema Raman, PhD, Reisa Sperling, MD, MMSc
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Biomarkers Unit
Lead: Robert Rissman, PhD
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Biostatistics Unit
Co-Leads: Michael Donohue, PhD, Rema Raman, PhD
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Clinical Outcome Instruments Unit
Co-Leads: Ronald Petersen, MD, PhD, Dorene Rentz, PsyD
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Informatics Unit
Lead: Gustavo Jimenez-Maggiora, PhD, MBA
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Medical Safety Unit
Lead: Michael Rafii, MD, PhD
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MRI Unit
Co-Leads: Michael Weiner, MD, Clifford Jack, MD, Petrice Cogswell, MD, PhD
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Neuropathology Unit
Co-Leads: Matthew Frosch, MD, PhD, Gregory Jicha, MD, PhD
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PET Unit
Lead: Keith Johnson, MD
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Recruitment, Engagement, and Retention Unit
Co-Leads: Joshua Grill, PhD, Rema Raman, PhD
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Administration Unit

Lead:
Jeremy Pizzola
About:
The Administration Unit serves to coordinate the activities of ACTC, including interfacing with other units and committees, project teams, and each of the sites. Essential components of the Administration Unit include Regulatory Affairs, Fiscal Management, Contracts, Human Resources, and Quality Assurance.

Alzheimer’s Clinical Trials Education, Engagement, Access, and Accountability (ACT-E2A2) Unit

Co-Leads:
Rema Raman
PhD
Reisa Sperling
MD, MMSc
Training and Mentoring Lead:
Dorene Rentz
Dorene Rentz
PsyD
Emerging Leaders Representative:
Athene Lee
PhD
Internal Advisory Board Chair:
David Geldmacher
MD
About:
The Education, Engagement, Access, and Accountability (ACT-E2A2) Unit aims to create an equitable and inclusive environment within ACTC activities through inculcating Justice, Equity, Diversity, and Inclusion (JEDI) principles across the consortium culture, strategy, and processes. These principles will establish the framework to identify, train, and sponsor a well-trained and diverse workforce and leadership to design, execute, and lead the next generation of ACTC clinical trials. The primary objectives of the unit are (1) to establish an ACTC strategic plan based on a JEDI leadership model, (2) expand existing networking, training, and education programs to support ACTC clinical trials staff, early and mid-career investigators, and emerging leaders, and (3) create opportunities for advancement for the next generation of leaders for ACTC.

Biomarkers Unit

Lead:
Robert Rissman
PhD
About:
The Biomarkers Unit manages the Biorepository at the ACTC Coordinating Center as well as the distributed efforts on assay optimization for early stage trials at several member sites. The key objective of the unit is to provide the infrastructure necessary for storage, pharmacokinetics screening, and optimization of tools for preventive studies.

Biostatistics Unit

Co-Leads:
Michael Donohue
PhD
Rema Raman
PhD
Co-Associate Leads:
Karin Ernstrom
MS
Oliver Langford
MSc
About:
The Biostatistics Unit aims to advance clinical trials of Alzheimer’s and related dementias (ADRD) through the utilization and development of innovative trial design, a comprehensive quality assurance program, and state-of-the-art statistical methodologies and analytic approaches. These approaches allow the rapid start-up of trials, real-time monitoring of data quality, sophisticated statistical analysis, and effective sharing of archived data. The primary aims of the unit are to (1) provide statistical leadership in the design, conduct, and analysis of ACTC projects; (2) ensure the integrity, rigor, and reproducibility of study results; and (3) conduct innovative statistical research in ADRD.

Clinical Outcome Instruments Unit

Co-Leads:
Ronald Petersen
MD, PhD
Dorene Rentz
Dorene Rentz
PsyD
About:
The Clinical Outcome Instrument Unit brings extensive experience in designing and implementing novel tools to assess cognitive function across the continuum. The unit in addition provides oversight and guidance to the quality of cognitive assessment in ACTC programs. This effort includes training and certification of raters and audio recording of all primary outcome assessments with central review and performance feedback.

Informatics Unit

Lead:
Gustavo Jimenez-Maggiora
PhD, MBA
About:
The Informatics Unit is composed of two groups: Data Management and Informatics. The unit develops and maintains the ACTC Informatics Platform (ACTC-IP) to support ACTC and its scientific aims. The ACTC-IP serves as an extensible, secure, and scalable information, collaboration, and process management infrastructure to facilitate the effective execution of program and study-related research activities by ACTC units, investigators, study teams, and sites. The ACTC-IP provides facilities to collect, store, process, analyze, visualize, audit, and share scientific, operational, and administrative data using standardized data models, formats, and taxonomies.

Medical Safety Unit

Lead:
Michael Rafii
MD, PhD
About:
The Medical Safety Unit provides oversight to the safety and conduct of ACTC’s entire portfolio of clinical trials. This is accomplished through medical and safety monitoring, clinical site monitoring, coding and review of adverse events, review of protocol deviations, and responding to medical questions from sites regarding study conduct. The ultimate goal of the unit is to ensure the safety of all participants in ACTC clinical trials and to develop better methods for clinical trials safety monitoring.

MRI Unit

Co-Leads:
Michael Weiner
MD
Clifford Jack
MD
Petrice Cogswell
MD, PhD
About:
The MRI Unit provides a comprehensive set of services that address all aspects of MRI needed for clinical trials including: designing imaging acquisition protocols tailored to any proposed study design, implementing protocols on all vendor systems needed for any given trial, site qualification, updating protocols when systems are upgraded, ongoing monitoring and image quality control, and implementing image analysis methods that address needs of any proposed study.

Neuropathology Unit

Co-Leads:
Matthew Frosch
MD, PhD
Gregory Jicha
MD, PhD
About:
The Neuropathology Unit captures the critical information available from autopsy examination of clinical trial subjects, in order to: confirm pathologic diagnosis, define endophenotypes, elucidate the biological action of the treatment (including both on and off-target effects that may underlie adverse events), unravel multifactorial contributions to the clinical state (including comorbid pathologies that may alter the response to the intervention), and bank tissue for future investigations.

PET Unit

Lead:
Keith Johnson
MD
About:
The PET Unit provides a comprehensive set of services that address all aspects of PET needed for ACTC programs including: designing protocols tailored to a proposed study design (project-specific use of amyloid PET for inclusion/exclusion and outcome assessment, and use of Tau PET, FDG, or other tracers for outcome assessments), and implementing these protocols at sites.

Recruitment, Engagement, and Retention Unit

Co-Leads:
Joshua Grill
PhD
Rema Raman
PhD
Co-Associate Leads:
Crystal Glover
PhD
Doris Molina-Henry
PhD
About:
The Recruitment, Engagement, and Retention (RER) Unit aims to accelerate participant accrual, enhance participant demographic diversity, and maximize retention in ACTC clinical trials using culturally cognizant, data-driven, and evidence-based strategies. The unit also engages in the science of recruitment to expand the available evidence and to develop methodologically rigorous approaches to improve trial recruitment outcomes. The primary aims of the unit are (1) to provide RER leadership in designing trials that are feasible and can successfully enroll inclusive samples, (2) to develop and sustain engagement and collaborations among study sites and community-based researchers with established partnerships and trust in underrepresented communities, and (3) to develop and utilize an evidence base to instruct clinical trial recruitment and retention approaches and resource expenditures, and to widely disseminate learnings to the field.