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PTPInvestigational Products for Progressive Supranuclear Palsy

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What is being tested

AADvac1

+ LM11A-31

BiologicalDrug
Who is being recruted

Basal Ganglia Diseases+13

+ Brain Diseases

+ Central Nervous System Diseases

From 41 to 86 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: December 2025
See protocol details

Summary

Principal SponsorAdam Boxer
Study ContactATRI Recruitment and Retention (RER) Unit
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2025

Actual date on which the first participant was enrolled.

This clinical trial is focused on understanding and finding treatments for Progressive Supranuclear Palsy (PSP), a rare brain disorder that affects movement, balance, and eye movements. The trial uses a unique approach called a perpetual platform trial, which means it can continuously test multiple treatments over time. The trial aims to evaluate different investigational products simultaneously or one after another, providing a flexible way to discover effective treatments for PSP. This is important because PSP currently has limited treatment options, and new therapies could significantly improve the quality of life for those affected. Participants in this trial are randomly assigned to one of the available treatment regimens, each of which includes a study drug and a placebo. The trial follows a master protocol, but specific details about each treatment option are provided in separate documents for each regimen. As new treatments become available, new regimens are added, and more participants are enrolled. This setup allows the trial to adapt and continue searching for effective treatments without starting from scratch each time. The potential benefits of participating include access to new therapies that could alleviate symptoms, but the risk of receiving a placebo instead of an active treatment is also present.

Official TitleThe Progressive Supranuclear Palsy Clinical Trial Platform
NCT07173803
Principal SponsorAdam Boxer
Study ContactATRI Recruitment and Retention (RER) Unit
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

440 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 41 to 86 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesCranial Nerve DiseasesEye DiseasesMovement DisordersNervous System DiseasesNeurologic ManifestationsOphthalmoplegiaParalysisSigns and SymptomsSupranuclear Palsy, ProgressivePathological Conditions, Signs and SymptomsOcular Motility DisordersNeurodegenerative DiseasesTauopathies

Criteria

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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