Not Yet RecruitingPhase 2

The Progressive Supranuclear Palsy Clinical Trial Platform - Regimen A: AADvac1

146 participantsStarted 2026-06-30

Plain-language summary

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.

Who can participate

Age range41 Years – 86 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.
✕. Any unstable and/or clinically significant medical condition likely to hamper the evaluation of safety and/or efficacy of study drug (e.g., clinically significant reduction in serum B12 or folate levels, clinically significant abnormalities of thyroid function, stroke, or other cerebrovascular or cardiovascular conditions), as per the site PI's judgment.

What they're measuring

Disease progression

Timeframe: 52 weeks

Trial details

NCT IDNCT07217665

SponsorAdam Boxer

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-09-28

Contact for this trial

PTP Recruitment and Retention (RER) Team

213-821-0569 psp-participate@usc.edu

View on ClinicalTrials.gov More PSP - Progressive Supranuclear Palsy trials