ClinicalTrials.gg
RecruitingNCT07173803PTPUpdated Nov 10, 2026

The Progressive Supranuclear Palsy Clinical Trial Platform

A Phase 2 interventional study of AADvac1 and LM11A-31 in Progressive Supranuclear Palsy(PSP), sponsored by Adam Boxer. Recruiting at 21 sites in United States. Open to participants aged 41 Years to 86 Years. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Adam Boxer · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Updated Nov 10, 2026Site recruiting status changed11 sites added+1 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
440
Allocation
Randomized
Ages
41 Years to 86 Years
Sex
All
01

Study 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.

Read the detailed 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
02

Conditions studied

  • Progressive Supranuclear Palsy(PSP)

Keywords

  • PSP
  • Placebo-Controlled
  • Double-Blind
  • Master Protocol
03

In context

Supranuclear Palsy, Progressive

171 studies on the registry are indexed under Supranuclear Palsy, Progressive; 51 are open to participants now.

This study's planned enrollment of 440 is above the median of 43 across 102 interventional studies indexed under Supranuclear Palsy, Progressive.

Browse Supranuclear Palsy, Progressive studies →

Lead sponsor

Adam Boxer is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
41 Years to 86 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. (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

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 who did not use a highly effective method of 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. 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 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. 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 (HbA1c) levels of ≥8.0%.
  19. Known history of (HIV-1 or 2).
  20. Known history of acute/chronic or C unless treated curatively.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
440 participants (estimated)

Study arms

  • Experimental
    Regimen A: AADvac1

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

    Biological: AADvac1

  • Experimental
    Regimen B: LM11A-31

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

    Drug: LM11A-31

Interventions

  • BiologicalAADvac1

    Active immunotherapy

  • DrugLM11A-31

    Small molecule

06

What researchers measure

Primary outcomes

  1. Disease progression

    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.

    Time frame: 52 weeks

Secondary outcomes

  1. Disease progression

    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.

    Time frame: 52 weeks

  2. Disease progression

    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.

    Time frame: 52 weeks

  3. Experiences of daily living

    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.

    Time frame: 52 weeks

  4. Activities of daily living

    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.

    Time frame: 52 weeks

  5. Disease severity

    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.

    Time frame: 52 weeks

  6. Disease progression

    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.

    Time frame: 52 weeks

  7. Health-related quality of life

    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.

    Time frame: 52 weeks

  8. Brain volume

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

    Time frame: 52 weeks

  9. Neurodegeneration

    Change in plasma neurofilament light chain (NfL) concentration.

    Time frame: 52 weeks

07

Study locations

5 of 21 sites recruiting
  • Banner Sun Health Research Institute
    Sun City, Arizona 10515, United States
    Not yet recruiting
    • David Shprecher, MD · Principal investigator
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
    Not yet recruiting
    • Yvette Bordelon, MD, PhD · Principal investigator
  • Stanford University
    Palo Alto, California 94304, United States
    Not yet recruiting
    • Niyatee Samudra, MD · Principal investigator
  • University of California, San Diego
    San Diego, California 92093, United States
    Not yet recruiting
    • Katherine Longardner, MD · Principal investigator
  • University of California, San Francisco
    San Francisco, California 94158, United States
    Recruiting
    • Julio Rojas-Martinez, MD, PhD · Principal investigator
  • University of Colorado Anschutz
    Aurora, Colorado 80045, United States
    Not yet recruiting
    • Samantha Holden, MD · Principal investigator
  • Yale University
    New Haven, Connecticut 06510, United States
    Not yet recruiting
    • Veronica Santini, MD · Principal investigator
  • Northwestern University
    Chicago, Illinois 60611, United States
    Not yet recruiting
    • Rizwan Akhtar, MD, PhD · Principal investigator
  • Rush University
    Chicago, Illinois 60612, United States
    Not yet recruiting
    • Jori Fleisher, MD · Principal investigator
  • Indiana University
    Indianapolis, Indiana 46202, United States
    Not yet recruiting
    • Jared Brosch, MD · Principal investigator
  • University of Maryland School of Medicine
    Baltimore, Maryland 21201, United States
    Not yet recruiting
    • Joseph Savitt, MD, PhD · Principal investigator
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
    Recruiting
    • Catherine Isroff, MD · Principal investigator
  • Albany Medical College
    Albany, New York 12208, United States
    Not yet recruiting
    • Octavian Adam, MD · Principal investigator
  • University of Cincinnati
    Cincinnati, Ohio 45267, United States
    Not yet recruiting
    • Emily Hill, MD · Principal investigator
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
    Not yet recruiting
    • David Irwin, MD · Principal investigator
  • University of Pittsburgh
    Pittsburgh, Pennsylvania 15213, United States
    Not yet recruiting
    • Edward Burton, MD, PhD · Principal investigator
  • Butler Hospital
    Providence, Rhode Island 02906, United States
    Recruiting
    • Edward Huey, MD · Principal investigator
  • Baylor College of Medicine
    Houston, Texas 77030, United States
    Not yet recruiting
    • Chi-Ying Roy Lin, MD · Principal investigator
  • Houston Methodist Neurological Institute
    Houston, Texas 77030, United States
    Recruiting
    • Joseph Masdeu, MD, PhD · Principal investigator
  • Virginia Commonwealth University
    Richmond, Virginia 11958, United States
    Not yet recruiting
    • Matthew Barrett, MD · Principal investigator
  • University of Washington, Memory and Brain Wellness Center
    Seattle, Washington 98195, United States
    Recruiting
    • Michael Rosenbloom, MD, FAAN · Principal investigator
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

6 registry updates since Sep 25, 2026
Sites
11 sites added, 2 sites removed. 2 sites changed recruiting status (2 now recruiting)
Show 2 sites
  • Massachusetts General Hospital · Boston, United StatesNot yet recruiting→Recruiting
  • University of Washington, Memory and Brain Wellness Center · Seattle, United StatesNot yet recruiting→Recruiting
Show 11 added (11 United States)
  • Banner Sun Health Research Institute · Sun City, United States
  • Rush University · Chicago, United States
  • Indiana University · Indianapolis, United States
  • University of Maryland School of Medicine · Baltimore, United States
  • University of Pennsylvania · Philadelphia, United States
  • Baylor College of Medicine · Houston, United States
  • University of Washington, Memory and Brain Wellness Center · Seattle, United States
  • Yale University · New Haven, United States
  • Northwestern University · Chicago, United States
  • University of Pittsburgh · Pittsburgh, United States
  • Houston Methodist Neurological Institute · Houston, United States
Show 2 removed
  • University of Washington · Seattle, United States
  • Houston Methodist · Houston, United States
across 6 updates, Oct 7, 2026 – Nov 10, 2026
Show all 6 updates
  1. Nov 10, 2026
    1 site added, 1 site removed
    Show site
    • Houston Methodist Neurological Institute · Houston, United States
    Show 1 removed
    • Houston Methodist · Houston, United States
  2. Nov 5, 2026
    3 sites added
    Show 3 added (3 United States)
    • Yale University · New Haven, United States
    • Northwestern University · Chicago, United States
    • University of Pittsburgh · Pittsburgh, United States
    + 1 other change: verification date
  3. Oct 27, 2026
    University of Washington, Memory and Brain Wellness Center is now Recruiting
  4. Oct 22, 2026
    Massachusetts General Hospital is now Recruiting
  5. Oct 9, 2026
    6 sites added, 1 site removed
    Show 6 added (6 United States)
    • Rush University · Chicago, United States
    • Indiana University · Indianapolis, United States
    • University of Maryland School of Medicine · Baltimore, United States
    • University of Pennsylvania · Philadelphia, United States
    • Baylor College of Medicine · Houston, United States
    • University of Washington, Memory and Brain Wellness Center · Seattle, United States
    Show 1 removed
    • University of Washington · Seattle, United States
  6. Oct 7, 2026
    1 site added
    Show site
    • Banner Sun Health Research Institute · Sun City, United States

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07173803
Lead sponsor
Adam Boxer
Collaborators
National Institute on Aging (NIA), Alzheimer's Therapeutic Research Institute, University of Southern California, Massachusetts General Hospital, University of California, San Diego, Alzheimer's Clinical Trials Consortium
Responsible party
Adam Boxer (Endowed Professor in Memory and Aging, University of California, San Francisco) — Sponsor-investigator
First posted
Sep 15, 2025
Start date
Jul 29, 2026
Primary completion
Sep 28, 2030 (estimated)
Completion
Sep 28, 2030 (estimated)
Last update
Nov 10, 2026

Study contacts

PSP Trial Platform Team
Contact
psptrialplatform@ucsf.edu
415-514-9420
Adam Boxer, MD, PhD
principal investigator · University of California, San Francisco
Irene Litvan, MD
principal investigator · University of California, San Diego
Julio Rojas-Martinez, MD, PhD
principal investigator · University of California, San Francisco
Anne-Marie Wills, MD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: AADvac1

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