Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-01-02 @ 10:39 AM
Study NCT ID:
NCT07173803
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Progressive Supranuclear Palsy Clinical Trial Platform
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013494', 'term': 'Supranuclear Palsy, Progressive'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D009886', 'term': 'Ophthalmoplegia'}, {'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000709631', 'term': 'AADvac1'}, {'id': 'C575077', 'term': 'LM11A-31'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 440}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-09-03', 'studyFirstSubmitQcDate': '2025-09-10', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease progression', 'timeFrame': '52 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Disease progression', 'timeFrame': '52 weeks', 'description': '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.'}, {'measure': 'Disease progression', 'timeFrame': '52 weeks', 'description': '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.'}, {'measure': 'Experiences of daily living', 'timeFrame': '52 weeks', 'description': '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.'}, {'measure': 'Activities of daily living', 'timeFrame': '52 weeks', 'description': '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.'}, {'measure': 'Disease severity', 'timeFrame': '52 weeks', 'description': '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.'}, {'measure': 'Disease progression', 'timeFrame': '52 weeks', 'description': '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.'}, {'measure': 'Health-related quality of life', 'timeFrame': '52 weeks', 'description': '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.'}, {'measure': 'Brain volume', 'timeFrame': '52 weeks', 'description': 'Change in volume in midbrain, pontine and other regions over time as measured by volumetric MRI.'}, {'measure': 'Neurodegeneration', 'timeFrame': '52 weeks', 'description': 'Change in plasma neurofilament light chain (NfL) concentration.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PSP', 'Placebo-Controlled', 'Double-Blind', 'Master Protocol'], 'conditions': ['Progressive Supranuclear Palsy(PSP)']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIn 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.\n\nThe 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.\n\nParticipants 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.\n\nNew regimens will be continuously added as new investigational products become available. PTP will enroll additional participants as each new regimen becomes available.\n\nPTP is expected to launch with the following regimen:\n\n* Regimen A: AADvac1\n* Regimen B: LM11A-31'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '86 Years', 'minimumAge': '41 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Clinical diagnosis of possible or probable PSP Richardson's Syndrome as defined by the 2017 Movement Disorder Society (MDS) criteria.\n2. Presence of PSP symptoms for ≤5 years at screening (based on the best judgment of the site PI).\n3. Mini-Mental State Examination (MMSE) score at screening of ≥25.\n4. Able to walk at least 10 steps with minimal assistance (e.g., one arm for safety, but not postural support).\n5. Stable doses of permitted medications as described per protocol for 30 days prior to screening.\n6. Resides at home or in the community (assisted living is acceptable).\n7. 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.\n\nExclusion Criteria:\n\n1. Females who are breastfeeding or pregnant (as documented by a urine pregnancy test) during screening, or plan to become pregnant during the study.\n2. 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.\n3. Lacks good venous access such that multiple blood draws would be precluded.\n4. Weighs less than 40kg, or more than 136kg at screening.\n5. Blood transfusion within 4 weeks of screening.\n6. Contraindications to MRI studies, including metal (ferromagnetic) implants, a cardiac pacemaker that is not compatible with MRI, and/or severe claustrophobia.\n7. 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.\n8. 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.\n9. History of severe allergic reaction (e.g., anaphylaxis) including but not limited to: severe allergic reaction to previous vaccines, foods, and/or medications.\n10. Hospitalization within 30 days prior to screening or baseline.\n11. Infections or major surgical procedures within 3 months prior to screening, judged to be clinically significant by the site PI.\n12. Myocardial infarction within 1 year prior to baseline, unstable angina pectoris, symptomatic congestive heart failure.\n13. 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.\n14. History or presence of immunological or inflammatory conditions, including neurological disorders, meningitis or meningoencephalitis.\n15. History or presence of epilepsy requiring ongoing use of antiepileptic medications. Antiepileptic medications are permitted for pain or psychiatric use per the protocol.\n16. DSM-5 criteria for drug or alcohol abuse or dependence currently met within the past 5 years.\n17. Clinically significant abnormal vital signs including sustained sitting blood pressure \\>160/100 mm Hg.\n18. Diabetes mellitus with hemoglobin A1c (HbA1c) levels of ≥8.0%.\n19. Known history of human immunodeficiency virus (HIV-1 or 2).\n20. Known history of acute/chronic hepatitis B or C unless treated curatively."}, 'identificationModule': {'nctId': 'NCT07173803', 'acronym': 'PTP', 'briefTitle': 'The Progressive Supranuclear Palsy Clinical Trial Platform', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'The Progressive Supranuclear Palsy Clinical Trial Platform', 'orgStudyIdInfo': {'id': 'ATRI-015'}, 'secondaryIdInfos': [{'id': 'R01AG085029', 'link': 'https://reporter.nih.gov/quickSearch/R01AG085029', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Regimen A: AADvac1', 'description': 'Participants are randomized to receive either active AADvac1 or matching placebo.', 'interventionNames': ['Biological: AADvac1']}, {'type': 'EXPERIMENTAL', 'label': 'Regimen B: LM11A-31', 'description': 'Participants are randomized to receive either active LM11A-31 or matching placebo.', 'interventionNames': ['Drug: LM11A-31']}], 'interventions': [{'name': 'AADvac1', 'type': 'BIOLOGICAL', 'description': 'Active immunotherapy', 'armGroupLabels': ['Regimen A: AADvac1']}, {'name': 'LM11A-31', 'type': 'DRUG', 'description': 'Small molecule', 'armGroupLabels': ['Regimen B: LM11A-31']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'ATRI Recruitment and Retention (RER) Unit', 'role': 'CONTACT', 'email': 'psp-participate@usc.edu', 'phone': '213-821-0569'}], 'overallOfficials': [{'name': 'Adam Boxer, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Irene Litvan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}, {'name': 'Julio Rojas-Martinez, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Anne-Marie Wills, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adam Boxer', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}, {'name': "Alzheimer's Therapeutic Research Institute", 'class': 'OTHER'}, {'name': 'University of Southern California', 'class': 'OTHER'}, {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, {'name': 'University of California, San Diego', 'class': 'OTHER'}, {'name': "Alzheimer's Clinical Trials Consortium", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Endowed Professor in Memory and Aging', 'investigatorFullName': 'Adam Boxer', 'investigatorAffiliation': 'University of California, San Francisco'}}}}