ClinicalTrials.gov record NCT07173803
The Progressive Supranuclear Palsy Clinical Trial Platform
The Progressive Supranuclear Palsy Clinical Trial Platform
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
PTP is a Phase 2, placebo-controlled, randomized, double-blind platform trial testing investigational treatments for progressive supranuclear palsy (PSP). A single Master Protocol lets multiple regimens be tested simultaneously or one after another; participants are first randomized to an active regimen, then randomized within that regimen to the investigational drug or matching placebo. The platform will add new regimens over time; initial regimens named are AADvac1 and LM11A-31.
What it is studying. Whether investigational products for PSP affect disease progression, clinical measures, MRI brain volume, and blood biomarkers compared with placebo.
What the researchers hope to learn. To evaluate safety and the effects of investigational PSP treatments on disease progression measured by PSP rating scales, activities/daily living measures, quality of life (EQ-5D-5L), brain volume by MRI, and plasma neurofilament light chain (NfL).
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- LM11A-31
- Biological
- AADvac1
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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.
- 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.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
If eligible, you will be randomized in a double‑blind way to receive either an active investigational product or matching placebo and may be assigned to any regimen active at the time of screening (regimens such as AADvac1 or LM11A-31 are planned). Participation involves in-person study visits and assessments over about 52 weeks, including clinical rating scales (PSPRS versions), cognitive testing (MMSE), and questionnaires about daily function and quality of life. You will have MRI scans and repeated blood draws for biomarker testing. Regimen-specific procedures, visit schedules, and any additional tests are described in separate regimen appendices and their individual ClinicalTrials.gov postings.
How the study is structured. A perpetual Phase 2 interventional 'platform' trial using one Master Protocol. Multiple investigational regimens (drug or biological) are tested either at the same time or sequentially. At screening, participants are randomized among active regimens and then randomized within a regimen to active treatment or matching placebo; the trial is double-blind (participants, care providers, investigators, and assessors are masked). Regimen-specific details, outcomes, and schedules are provided in separate appendices and separate ClinicalTrials.gov postings.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on progressive supranuclear palsy
Important dates
- Study start
- Jul 29, 2026
- Primary completion
- Sep 28, 2030 (estimated)
- Study completion
- Sep 28, 2030 (estimated)
- Target enrollment
- 440 participants (estimated)
- Last updated on registry
- Oct 9, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- 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
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- PSP Trial Platform Team 📞 415-514-9420 ✉ psptrialplatform@ucsf.edu
Participating sites (18)
- Banner Sun Health Research InstituteNot Yet Recruiting
Sun City, Arizona, 10515 · United States
- David Shprecher, MD
- Cedars-Sinai Medical CenterNot Yet Recruiting
Los Angeles, California, 90048 · United States
- Yvette Bordelon, MD, PhD
- Stanford UniversityNot Yet Recruiting
Palo Alto, California, 94304 · United States
- Niyatee Samudra, MD
- University of California, San DiegoNot Yet Recruiting
San Diego, California, 92093 · United States
- Katherine Longardner, MD
- University of California, San FranciscoRecruiting
San Francisco, California, 94158 · United States
- Julio Rojas-Martinez, MD, PhD
- University of Colorado AnschutzNot Yet Recruiting
Aurora, Colorado, 80045 · United States
- Samantha Holden, MD
- Rush UniversityNot Yet Recruiting
Chicago, Illinois, 60612 · United States
- Jori Fleisher, MD
- Indiana UniversityNot Yet Recruiting
Indianapolis, Indiana, 46202 · United States
- Jared Brosch, MD
- University of Maryland School of MedicineNot Yet Recruiting
Baltimore, Maryland, 21201 · United States
- Joseph Savitt, MD, PhD
- Massachusetts General HospitalNot Yet Recruiting
Boston, Massachusetts, 02114 · United States
- Catherine Isroff, MD
Terms used on this page · explanations by MedicalUpdates.ai
- investigational
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- at screening
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- childbearing potential
- Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
- Contraindications
- A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
- MRI
- A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
- baseline
- Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- placebo-controlled
- A study design in which one group receives a placebo so that the study treatment's effects can be compared with no active treatment.
- matching placebo
- A treatment that looks like the study treatment but contains no active ingredient. Some participants receive it instead of the study treatment, usually without knowing which they got.
- outcome measures
- Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.
- randomized
- Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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