The Progressive Supranuclear Palsy Clinical Trial Platform - Regimen A: AADvac1
ConditionPSP - Progressive Supranuclear Palsy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age41-86
SponsorAdam Boxer
About this trial
The Progressive Supranuclear Palsy Clinical Trial Platform (PTP) is a multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of PSP.
Regimen A will evaluate the safety and efficacy of a single study drug, AADvac1, in participants with PSP.
Eligibility criteria
Qualifiers
Clinical diagnosis of possible or probable PSP Richardson's Syndrome as defined by the 2017 Movement Disorder Society (MDS) criteria.
Presence of PSP symptoms for ≤5 years at screening (based on the best judgment of the site PI).
Mini-Mental State Examination (MMSE) score at screening of ≥25.
Able to walk at least 10 steps with minimal assistance (e.g., one arm for safety, but not postural support).
Disqualifiers
Females who are breastfeeding or pregnant (as documented by a urine pregnancy test) during screening, or plan to become pregnant during the study.
Females of childbearing potential who did not use a highly effective method of contraception within 28 days of screening and/or are not willing to use a highly effective method of contraception for the duration of their participation in the study.
Lacks good venous access such that multiple blood draws would be precluded.
Weighs less than 40kg, or more than 136kg at screening.
Trial design
Treatments tested in this trial
- AADvac1
- Matching Placebo
Treatment groups
146 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Adam Boxer
Lead sponsor
University of California, San Francisco
Sponsor institution
National Institute on Aging (NIA)
Collaborator
Alzheimer's Therapeutic Research Institute
Collaborator
University of Southern California
Collaborator
Massachusetts General Hospital
Collaborator
University of California, San Diego
Collaborator
Alzheimer's Clinical Trials Consortium
Collaborator
Axon Neuroscience SE
Collaborator
Source ClinicalTrials.gov