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Progressive Supranuclear Palsy(PSP)Phase 2PTPNCT07173803

The Progressive Supranuclear Palsy Clinical Trial Platform

A Phase 2 study testing AADvac1 and LM11A-31 in people with Progressive Supranuclear Palsy(PSP), run by Adam Boxer at 18 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 41 to 86 years
Conditions the study is for
Progressive Supranuclear Palsy(PSP)
What is being tested?
AADvac1 and LM11A-31
Could I receive a placebo?
No, everyone receives an active treatment
How many people
440 participants
Where
18 sitesUnited States
Study dates
29 Jul 2026to 28 Sep 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 41 to 86 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 cannot join

  • 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.
Show all 20Show fewer
  • 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.
  • History of severe allergic reaction (e.g., anaphylaxis) including but not limited to: severe allergic reaction to previous vaccines, foods, and/or medications.
  • Hospitalization within 30 days prior to screening or baseline.
  • Infections or major surgical procedures within 3 months prior to screening, judged to be clinically significant by the site PI.
  • Myocardial infarction within 1 year prior to baseline, unstable angina pectoris, symptomatic congestive heart failure.
  • 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.
  • History or presence of immunological or inflammatory conditions, including neurological disorders, meningitis or meningoencephalitis.
  • History or presence of epilepsy requiring ongoing use of antiepileptic medications. Antiepileptic medications are permitted for pain or psychiatric use per the protocol.
  • DSM-5 criteria for drug or alcohol abuse or dependence currently met within the past 5 years.
  • Clinically significant abnormal vital signs including sustained sitting blood pressure >160/100 mm Hg.
  • Diabetes mellitus with hemoglobin A1c (HbA1c) levels of ≥8.0%.
  • Known history of human immunodeficiency virus (HIV-1 or 2).
  • Known history of acute/chronic hepatitis B or C unless treated curatively.

Trial locations and contacts

18 sites in 1 country. Contact the study team or a site near you to ask about taking part.

PSP Trial Platform Team contact

415-514-9420

psptrialplatform@ucsf.edu

18 sites in 1 country

United States18 sites, 18 recruiting

  • Albany Medical College

    Albany, New York, 12208

    Octavian Adam, MD

    Not yet recruiting

  • University of Colorado Anschutz

    Aurora, Colorado, 80045

    Samantha Holden, MD

    Not yet recruiting

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

    Joseph Savitt, MD, PhD

    Not yet recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Catherine Isroff, MD

    Recruiting

  • Rush University

    Chicago, Illinois, 60612

    Jori Fleisher, MD

    Not yet recruiting

  • University of Cincinnati

    Cincinnati, Ohio, 45267

    Emily Hill, MD

    Not yet recruiting

  • Baylor College of Medicine

    Houston, Texas, 77030

    Chi-Ying Roy Lin, MD

    Not yet recruiting

  • Houston Methodist

    Houston, Texas, 77030

    Joseph Masdeu, MD, PhD

    Not yet recruiting

  • Indiana University

    Indianapolis, Indiana, 46202

    Jared Brosch, MD

    Not yet recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Yvette Bordelon, MD, PhD

    Not yet recruiting

  • Stanford University

    Palo Alto, California, 94304

    Niyatee Samudra, MD

    Not yet recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    David Irwin, MD

    Not yet recruiting

  • Butler Hospital

    Providence, Rhode Island, 02906

    Edward Huey, MD

    Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia, 11958

    Matthew Barrett, MD

    Not yet recruiting

  • University of California, San Diego

    San Diego, California, 92093

    Katherine Longardner, MD

    Not yet recruiting

  • University of California, San Francisco

    San Francisco, California, 94158

    Julio Rojas-Martinez, MD, PhD

    Recruiting

  • University of Washington, Memory and Brain Wellness Center

    Seattle, Washington, 98195

    Michael Rosenbloom, MD, FAAN

    Recruiting

  • Banner Sun Health Research Institute

    Sun City, Arizona, 10515

    David Shprecher, MD

    Not yet recruiting

Other trials in United States

About this study

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
Being tested
AADvac1, LM11A-31
Keywords
PSP, Placebo-Controlled, Double-Blind, Master Protocol
Medical subject headings
Supranuclear Palsy, Progressive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AADvac1Biological

    Active immunotherapy

  • LM11A-31Drug

    Small molecule

Study groups in NCT07173803
Study groupRoleWhat they receive
Regimen A: AADvac1ExperimentalParticipants are randomized to receive either active AADvac1 or matching placebo.
Receives: Biological: AADvac1
Regimen B: LM11A-31ExperimentalParticipants are randomized to receive either active LM11A-31 or matching placebo.
Receives: Drug: LM11A-31

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 52 weeks

Secondary outcomes (9)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 52 weeks

  8. Brain volume

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

    Measured: 52 weeks

  9. Neurodegeneration

    Change in plasma neurofilament light chain (NfL) concentration.

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2025
  2. Study start29 Jul 2026
  3. Primary completion28 Sep 2030 (estimated)
  4. Study completion28 Sep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
440 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07173803
Sponsor's protocol ID
ATRI-015
Other IDs
R01AG085029
Acronym
PTP
Status last verified
Nov 2025
First submitted
3 Sep 2025
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AADvac1 and LM11A-31 in people with Progressive Supranuclear Palsy(PSP), run by Adam Boxer at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact PSP Trial Platform Team (415-514-9420, psptrialplatform@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease progression (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07173803.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026; AzTrials last refreshed its copy on 31 Oct 2026.

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