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UnknownPhase 2

RT001 in Patients With Progressive Supranuclear Palsy (PSP) PROGRESSIVE SUPRANUCLEAR PALSY

A Randomized, Double-blind, Controlled, Phase 2 Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects With Progressive Supranuclear Palsy

Lead sponsor

Biojiva LLC

Asset

RT001

Listed sites

1

Recruiting sites

1

Enrollment

40

estimated

Study population

Frontotemporal dementia

Key I/E criterion

Study partner/caregiver required

Primary endpoint

The PSPRS-28

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04937530
Org study IDRT001-013

Timeline

Milestones

Study start2021-06-23actual
Study first posted2021-06-24actual
Last update posted2021-06-25actual
Primary completion2022-07-30estimated
Study completion2022-08-30estimated

Assets

Drug assets

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age40 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Sign the informed consent form prior to entry into the study

2. Male or female subject with age 40 years to 80 years at the time of signed consent

3. Meets the MDS-PSP study group criteria for possible or probable progressive supranuclear palsy with Richardson syndrome (postural instability and falls with vertical ocular motor dysfunction)

4. Presence of PSP symptoms for less than 4 years

5. Score of <40 on the PSPRS-28

6. Ambulatory patients (with or without assistive device - no handheld help) and capable of performing study assessments/evaluations

7. Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend) who can assist in assuring that the subject is able to travel to the required visits.

8. Willing to provide the necessary blood samples

Exclusion criteria

1. Received treatment with other experimental therapies within the last 30 days prior to the first dose. The last dose of the prior experimental agent must have occurred more than 5 half-lives prior to enrollment in the current trial.

2. Previously received treatment with RT001

3. Refusal to discontinue fish oils or other oil-based supplements for the duration of the study (Screening/Baseline till last study procedure completed)

4. Mini mental state examination (MMSE) score less than 20 at screening

5. Subject resides at a skilled nursing or dementia care facility, or admission to such a facility is planned during the study period

6. Evidence of any clinically significant neurological disorder other than PSP in particular CBS

7. Evidence of a clear and robust benefit from levodopa at the time of screening. Participants are permitted to take levodopa and other Parkinson's medications if the dose had been stable for 60 days prior to screening

8. The subject has a history of or currently has schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-V or ICD-10 criteria

9. Subject has had a significant illness or infection requiring medical intervention in the past 30 days

10. Subject has evidence of any disease or condition (based on either history, physical or laboratory values) that might interfere with the conduct of the study

11. Is currently receiving active deep brain stimulation (DBS) that cannot be turned off

12. Any condition with a life expectancy of less than 2 years

13. Female who is breastfeeding or has a positive pregnancy test

14. Male participant or female participant of childbearing potential, who is sexually active and unwilling/unable to use a highly effective birth control method throughout the study

15. Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to return for visits as scheduled

16. History, within the last 2 years, of alcohol abuse or physical opioid dependence

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Behavior / neuropsychiatric

1 endpoint
Primary/protocol endpoint

Change from baseline in the PSPRS-28 at 48 weeks for the RT001 treated group vs placebo-treated group

Time frame:48 weeks

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.