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RecruitingNCT07173803ClinicalTrials.gov record

The Progressive Supranuclear Palsy Clinical Trial Platform

Progressive Supranuclear Palsy(PSP)

THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type
Interventional
Phase
Phase 2
Age range
41 years - 86 years
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
440 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full description

The Progressive Supranuclear Palsy Clinical Trial Platform (PTP) is designed as a perpetual platform trial. This means that there is a single Master Protocol dictating the conduct of the trial.

In this trial, multiple investigational products for PSP will be tested simultaneously or sequentially. Each investigational product will be tested in a regimen. Each regimen consists of a placebo-controlled trial, meaning that the active investigational product and matching placebo will be tested in each regimen.

The additional details that govern the testing of each investigational product will be summarized in separate regimen-specific appendices (RSAs). Each regimen will have a separate ClinicalTrials.gov posting, which will include specific information about the regimen. All regimen-specific outcome measures will be detailed in each regimen posting.

Participants will have an equal chance to be randomized to all regimens that are active at the time of screening. Once randomized to a regimen, participants will be randomized as outlined for each individual regimen to either study drug or placebo.

New regimens will be continuously added as new investigational products become available. PTP will enroll additional participants as each new regimen becomes available.

PTP is expected to launch with the following regimen:

  • Regimen A: AADvac1
  • Regimen B: LM11A-31

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

1. Clinical diagnosis of possible or probable PSP Richardson's Syndrome as defined by the 2017 Movement Disorder Society (MDS) criteria.
2. Presence of PSP symptoms for ≤5 years at screening (based on the best judgment of the site PI).
3. Mini-Mental State Examination (MMSE) score at screening of ≥25.
4. Able to walk at least 10 steps with minimal assistance (e.g., one arm for safety, but not postural support).
5. Stable doses of permitted medications as described per protocol for 30 days prior to screening.
6. Resides at home or in the community (assisted living is acceptable).
7. 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:

1. Females who are breastfeeding or pregnant (as documented by a urine pregnancy test) during screening, or plan to become pregnant during the study.
2. 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.
3. Lacks good venous access such that multiple blood draws would be precluded.
4. Weighs less than 40kg, or more than 136kg at screening.
5. Blood transfusion within 4 weeks of screening.
6. Contraindications to MRI studies, including metal (ferromagnetic) implants, a cardiac pacemaker that is not compatible with MRI, and/or severe claustrophobia.
7. 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.
8. 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.
9. History of severe allergic reaction (e.g., anaphylaxis) including but not limited to: severe allergic reaction to previous vaccines, foods, and/or medications.
10. Hospitalization within 30 days prior to screening or baseline.
11. Infections or major surgical procedures within 3 months prior to screening, judged to be clinically significant by the site PI.
12. Myocardial infarction within 1 year prior to baseline, unstable angina pectoris, symptomatic congestive heart failure.
13. History of cancer within the past 5 years other than treated skin squamous cell carcinoma, basal cell carcinoma, and melanoma in-situ, localized prostate cancer not requiring treatment, or prostate or breast cancer, which have been fully removed and are considered cured.
14. History or presence of immunological or inflammatory conditions, including neurological disorders, meningitis or meningoencephalitis.
15. History or presence of epilepsy requiring ongoing use of antiepileptic medications. Antiepileptic medications are permitted for pain or psychiatric use per the protocol.
16. DSM-5 criteria for drug or alcohol abuse or dependence currently met within the past 5 years.
17. Clinically significant abnormal vital signs including sustained sitting blood pressure \>160/100 mm Hg.
18. Diabetes mellitus with hemoglobin A1c (HbA1c) levels of ≥8.0%.
19. Known history of human immunodeficiency virus (HIV-1 or 2).
20. Known history of acute/chronic hepatitis B or C unless treated curatively.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Random assignment
Masking
Quadruple masked
Regimen A: AADvac1

Participants are randomized to receive either active AADvac1 or matching placebo.

Biological: AADvac1

Regimen B: LM11A-31

Participants are randomized to receive either active LM11A-31 or matching placebo.

Drug: LM11A-31

AADvac1 BIOLOGICAL

Active immunotherapy

LM11A-31 DRUG

Small molecule

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Disease progression

Time frame: 52 weeks

Change in disease severity as measured by the 15-item modified Progressive Supranuclear Palsy Rating Scale (mPSPRS-15) in which the minimum score is 0 and the maximum score is 52, with higher scores indicating a worse outcome.

Secondary measures

Disease progression

Time frame: 52 weeks

Change in disease severity as measured by the 10-item modified Progressive Supranuclear Palsy Rating Scale (mPSPRS-10) in which the minimum score is 0 and the maximum score is 30, with higher scores indicating a worse outcome.

Disease progression

Time frame: 52 weeks

Change in disease severity as measured by the 28-item Progressive Supranuclear Palsy Rating Scale (28-item PSPRS) in which the minimum score is 0 and the maximum score is 100, with higher scores indicating a worse outcome.

Experiences of daily living

Time frame: 52 weeks

Change in experiences of daily living over time as measured by the Cortical Basal ganglia Functional Scale (CBFS) in which the minimum score is 0 and the maximum score is 124, with higher scores indicating a worse outcome.

Activities of daily living

Time frame: 52 weeks

Change in activities of daily living over time as measured by the Schwab and England Activities of Daily Living Scale (SE-ADL) in which the minimum score is 0% and the maximum score is 100%, with lower scores indicating a worse outcome.

Disease severity

Time frame: 52 weeks

Change in disease severity over time as measured by the Clinical Global Impression of disease severity (CGIds) using a 7-point scale, ranging from 1 (normal, not ill) to 7 (extremely ill), with a higher score indicating a worse outcome.

Disease progression

Time frame: 52 weeks

Change in disease severity over time as measured by the Clinical Global Impression of Change (CGIC) using a 7-point scale, ranging from 1 (very much improved) to 7 (very much worse), with a score of 4 indicating no change.

Health-related quality of life

Time frame: 52 weeks

Change in quality of life over time as measured by the EuroQoL 5 Dimension - 5 Level (EQ-5D-5L) questionnaire in which the minimum score is 0 and the maximum score is 1, with lower scores indicating a worse outcome.

Brain volume

Time frame: 52 weeks

Change in volume in midbrain, pontine and other regions over time as measured by volumetric MRI.

Neurodegeneration

Time frame: 52 weeks

Change in plasma neurofilament light chain (NfL) concentration.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (21)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

21 locations

Banner Sun Health Research InstituteSun City, Arizona, United StatesNot yet recruiting
David Shprecher, MDPRINCIPAL_INVESTIGATOR
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Cedars-Sinai Medical CenterLos Angeles, California, United StatesNot yet recruiting
Yvette Bordelon, MD, PhDPRINCIPAL_INVESTIGATOR
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Stanford UniversityPalo Alto, California, United StatesNot yet recruiting
Niyatee Samudra, MDPRINCIPAL_INVESTIGATOR
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University of California, San DiegoSan Diego, California, United StatesNot yet recruiting
Katherine Longardner, MDPRINCIPAL_INVESTIGATOR
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University of California, San FranciscoSan Francisco, California, United StatesRecruiting
Julio Rojas-Martinez, MD, PhDPRINCIPAL_INVESTIGATOR
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University of Colorado AnschutzAurora, Colorado, United StatesNot yet recruiting
Samantha Holden, MDPRINCIPAL_INVESTIGATOR
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Yale UniversityNew Haven, Connecticut, United StatesNot yet recruiting
Veronica Santini, MDPRINCIPAL_INVESTIGATOR
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Northwestern UniversityChicago, Illinois, United StatesNot yet recruiting
Rizwan Akhtar, MD, PhDPRINCIPAL_INVESTIGATOR
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Rush UniversityChicago, Illinois, United StatesNot yet recruiting
Jori Fleisher, MDPRINCIPAL_INVESTIGATOR
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Indiana UniversityIndianapolis, Indiana, United StatesNot yet recruiting
Jared Brosch, MDPRINCIPAL_INVESTIGATOR
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University of Maryland School of MedicineBaltimore, Maryland, United StatesNot yet recruiting
Joseph Savitt, MD, PhDPRINCIPAL_INVESTIGATOR
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Massachusetts General HospitalBoston, Massachusetts, United StatesRecruiting
Catherine Isroff, MDPRINCIPAL_INVESTIGATOR
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Albany Medical CollegeAlbany, New York, United StatesNot yet recruiting
Octavian Adam, MDPRINCIPAL_INVESTIGATOR
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University of CincinnatiCincinnati, Ohio, United StatesNot yet recruiting
Emily Hill, MDPRINCIPAL_INVESTIGATOR
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University of PennsylvaniaPhiladelphia, Pennsylvania, United StatesNot yet recruiting
David Irwin, MDPRINCIPAL_INVESTIGATOR
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University of PittsburghPittsburgh, Pennsylvania, United StatesNot yet recruiting
Edward Burton, MD, PhDPRINCIPAL_INVESTIGATOR
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Butler HospitalProvidence, Rhode Island, United StatesRecruiting
Edward Huey, MDPRINCIPAL_INVESTIGATOR
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Baylor College of MedicineHouston, Texas, United StatesNot yet recruiting
Chi-Ying Roy Lin, MDPRINCIPAL_INVESTIGATOR
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Houston Methodist Neurological InstituteHouston, Texas, United StatesRecruiting
Joseph Masdeu, MD, PhDPRINCIPAL_INVESTIGATOR
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Virginia Commonwealth UniversityRichmond, Virginia, United StatesNot yet recruiting
Matthew Barrett, MDPRINCIPAL_INVESTIGATOR
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University of Washington, Memory and Brain Wellness CenterSeattle, Washington, United StatesRecruiting
Michael Rosenbloom, MD, FAANPRINCIPAL_INVESTIGATOR
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Study team and timeline

Lead sponsor
Adam Boxer
Study start
Jul 29, 2026 Actual
Primary completion
Sep 28, 2030 Estimated
Study completion
Sep 28, 2030 Estimated
First posted
Sep 15, 2025 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

PSP Trial Platform TeamCONTACTpsptrialplatform@ucsf.edu415-514-9420
Official study title

The Progressive Supranuclear Palsy Clinical Trial Platform

A HUMAN NEXT STEP

Ask Wellness Clinical Research

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026