RecruitingPhase 2interventionalRules rewrite

Phase 2: testing AADvac1 for Progressive Supranuclear Palsy(PSP)

The Progressive Supranuclear Palsy Clinical Trial Platform (PTP) is a multi-center, multi-regimen clinical trial evaluating the safety and how well it works of investigational products for the treatment of PSP.

Official registry: https://clinicaltrials.gov/study/NCT07173803 · Adam Boxer · enrollment listed as 440

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are AADvac1, or LM11A-31. The registry lists allocation as randomized. The Progressive Supranuclear Palsy Clinical Trial Platform (PTP) is a multi-center, multi-regimen clinical trial evaluating the safety and how well it works of investigational products for the treatment of PSP.

They plan to enroll about 440 people at 21 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

The Progressive Supranuclear Palsy Clinical Trial Platform

Interventions: AADvac1, LM11A-31

Primary outcome (registry wording): Disease progression

Who it is for (from inclusion criteria)

Ages 41 Years to 86 Years
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)
Stable doses of permitted medications as described per protocol for 30 days prior to screening
Resides at home or in the community (assisted living is acceptable)
As assessed by the site PI, participant is likely to be able to comply with the protocol for the duration of the study, and has adequate vision, hearing (hearing aid permitted), and literacy (English or Spanish) sufficient for compliance with the required testing procedures

Who the registry excludes

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
Blood transfusion within 4 weeks of screening
Contraindications to MRI studies, including metal (ferromagnetic) implants, a cardiac pacemaker that is not compatible with MRI, and/or severe claustrophobia
Screening MRI scan showing structural evidence of alternative pathology not consistent with PSP that could explain a substantial portion of the participant's symptoms as indicated by the central MRI read

Public study contact (from the registry)

PSP Trial Platform Team

415-514-9420

psptrialplatform@ucsf.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

21 listed

Banner Sun Health Research Institute — Sun City, Arizona (not_yet_recruiting)
Cedars-Sinai Medical Center — Los Angeles, California (not_yet_recruiting)
Stanford University — Palo Alto, California (not_yet_recruiting)
University of California, San Diego — San Diego, California (not_yet_recruiting)
University of California, San Francisco — San Francisco, California (recruiting)
University of Colorado Anschutz — Aurora, Colorado (not_yet_recruiting)
Yale University — New Haven, Connecticut (not_yet_recruiting)
Northwestern University — Chicago, Illinois (not_yet_recruiting)
Rush University — Chicago, Illinois (not_yet_recruiting)
Indiana University — Indianapolis, Indiana (not_yet_recruiting)
University of Maryland School of Medicine — Baltimore, Maryland (not_yet_recruiting)
Massachusetts General Hospital — Boston, Massachusetts (recruiting)

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FAQ about this NCT record

Is NCT07173803 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07173803?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07173803?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary