PSP - Progressive Supranuclear PalsyPhase 2NCT07217665
The Progressive Supranuclear Palsy Clinical Trial Platform - Regimen A: AADvac1
A Phase 2 study testing AADvac1 in people with PSP - Progressive Supranuclear Palsy, run by Adam Boxer at 1 site in United States.
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. Regimen A will evaluate the safety and efficacy of a single study drug, AADvac1, in participants with PSP. Read more about this study
- Who is it for?
- Ages 41 to 86 years
- Conditions the study is for
- PSP - Progressive Supranuclear Palsy
- What is being tested?
- AADvac1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2026to 28 Sep 2030
- Phase
- Phase 2
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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, San Francisco (UCSF), Memory and Aging Center
San Francisco, California, 94158
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.
Regimen A will evaluate the safety and efficacy of a single study drug, AADvac1, in participants with 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. 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.
- Conditions
- PSP - Progressive Supranuclear Palsy
- Being tested
- AADvac1, Matching Placebo
- Keywords
- PSP, Placebo-Controlled, Double-Blind, Regimen Specific Appendix, AADvac1, Vaccine, Tau protein, Immunotherapy
- Medical subject headings
- Supranuclear Palsy, Progressive, Frontotemporal Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AADvac1Biological
AADvac1 administration: subcutaneous injection.
Matching PlaceboBiological
Matching placebo administration: subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| AADvac1 | Experimental | Not described Receives: Biological: AADvac1 |
| Matching Placebo | Placebo comparator | Not described Receives: Biological: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
Brain volume
Change in volume in midbrain, pontine and other regions over time as measured by volumetric MRI.
Measured: 52 weeks
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.
- First posted16 Oct 2025
- Study start29 Jul 2026
- Primary completion28 Sep 2030 (estimated)
- Study completion28 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PSP - Progressive Supranuclear PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adam Boxer
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor-investigator, Adam Boxer, University of California, San Francisco
- Investigators
- Adam Boxer, MD, PhD, Principal investigator, University of California, San FranciscoIrene Litvan, MD, Principal investigator, University of California, San DiegoJulio Rojas-Martinez, MD, PhD, Principal investigator, University of California, San FranciscoAnne-Marie Wills, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217665
- Sponsor's protocol ID
- ATRI-015-A
- Other IDs
- R01AG085029
- Status last verified
- Oct 2025
- First submitted
- 30 Sep 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes