ClinicalTrials.gov record NCT07217665
The Progressive Supranuclear Palsy Clinical Trial Platform - Regimen A: AADvac1
The Progressive Supranuclear Palsy Clinical Trial Platform - Regimen A: AADvac1
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.
This Phase 2 randomized trial evaluates the AADvac1 vaccine compared with placebo in people with progressive supranuclear palsy (PSP). Participants must first join the PTP Master Protocol and, if eligible, are randomized 3:1 to active vaccine or matching placebo and receive subcutaneous injections. The study measures disease progression and other clinical, imaging, and blood biomarker outcomes over 52 weeks.
What it is studying. The study tests whether AADvac1, given by subcutaneous injection, affects disease progression and related clinical, imaging, and blood biomarker measures in people with PSP compared with placebo.
What the researchers hope to learn. To evaluate the safety and treatment effects of AADvac1 in PSP. The primary scientific goal is to measure change in disease severity using the 15-item modified Progressive Supranuclear Palsy Rating Scale (mPSPRS-15) at 52 weeks. Secondary goals include other PSP rating scales, activities of daily living, 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. Regimen A will evaluate the safety and efficacy of a single study drug, AADvac1, in participants with PSP.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Biological
- AADvac1
- Matching Placebo
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. The PTP Master Protocol is registered as NCT07173803. Once a participant enrolls into the Master Protocol and meets all eligibility criteria, the participant will be eligible to be randomized into any currently enrolling regimen. All participants will have an equal chance to be randomized to all regimens that are active at the time of screening. If a participant is randomized to Regimen A: AADvac1, participants will complete a baseline assessment and be randomized in a 3:1 ratio to either active AADvac1 or matching placebo. Participants must first enroll into the Master Protocol and be eligible to participate in the Master Protocol before being able to be randomly assigned to Regimen A. For a list of enrolling sites, please see the PTP Master Protocol under NCT07173803.
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.
Participants first enroll into the PTP Master Protocol and, if eligible for Regimen A, are randomized 3:1 to receive AADvac1 or matching placebo given by subcutaneous injection. They complete a baseline assessment and repeated clinic visits over about 52 weeks for injections, multiple blood draws, MRI scans, cognitive and clinical rating scales, and questionnaires about symptoms and quality of life. Screening includes tests such as the MMSE, weight, pregnancy test for women, and MRI compatibility checks; some people will be excluded on safety grounds found at screening.
How the study is structured. Phase 2, randomized, parallel-group, placebo-controlled, quadruple-blind trial. People who enroll in the PTP Master Protocol and meet criteria may be randomized to Regimen A; randomization into Regimen A is 3:1 active AADvac1 versus matching placebo. Participants receive subcutaneous injections and are followed with clinical assessments, MRI scans, and blood tests, with key outcomes assessed at 52 weeks.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- Some participants receive a placebo. How is that decided, and what happens for placebo-group participants when the study ends?
- The registry says participants are enrolled by invitation. Who decides who is invited, and how?
- 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
- 146 participants (estimated)
- Last updated on registry
- Aug 13, 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
- Axon Neuroscience SE
Participating sites (1)
- University of California, San Francisco (UCSF), Memory and Aging Center
San Francisco, California, 94158 · United States
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.
- eligibility criteria
- The rules the study team uses to decide who may take part. They are usually split into inclusion criteria and exclusion criteria.
- 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.
- 3:1
- How many participants go to each group. In a 2:1 ratio, two are assigned to the first group for every one assigned to the second.
- 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.
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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