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The Progressive Supranuclear Palsy Clinical Trial Platform

ConditionProgressive Supranuclear Palsy(PSP)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age41-86
SponsorAdam Boxer

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • AADvac1

    Biological/Vaccine

    Active immunotherapy

  • LM11A-31

    Drug

    Small molecule

Treatment groups

440 Participants
are divided into 2 treatment groups
Group A: Regimen A: AADvac1Experimental treatment 1 intervention
Group B: Regimen B: LM11A-31Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
52 weeks

Secondary outcomes

1

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.

Time frame
52 weeks
2

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.

Time frame
52 weeks
3

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.

Time frame
52 weeks
4

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.

Time frame
52 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Adam Boxer

Lead sponsor

University of California, San Francisco

Sponsor institution

National Institute on Aging (NIA)

Collaborator

Alzheimer's Therapeutic Research Institute

Collaborator

University of Southern California

Collaborator

Massachusetts General Hospital

Collaborator

University of California, San Diego

Collaborator

Alzheimer's Clinical Trials Consortium

Collaborator

Source ClinicalTrials.gov
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