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CompletedPhase 2

A Phase 2a Study of TPN-101 in Patients With Progressive Supranuclear Palsy (PSP)

Asset

TPN-101

Listed sites

14

Recruiting sites

-

Enrollment

42

actual

Study population

Frontotemporal dementia

Key I/E criteria

MMSE ≥18Study partner/caregiver required

Primary endpoint

Assess the safety and tolerability of TPN-101

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 IDNCT04993768
Org study IDTPN-101-PSP-201

Timeline

Milestones

Study first posted2021-08-06actual
Study start2021-12-12actual
Primary completion2024-02-24actual
Study completion2024-03-24actual
Last update posted2026-04-08actual

Assets

Drug assets

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age41 Years
Maximum age86 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Clinical diagnosis of probable progressive supranuclear palsy (PSP)

2. Presence of PSP symptoms for less than 5 years

3. Has a reliable caregiver/informant to accompany the patient to all study visits.

4. Score ≥ 18 on the Mini Mental State Exam (MMSE) at Screening

5. Patient must reside outside a skilled nursing facility or dementia care facility at the time of Screening, and admission to such a facility must not be planned. Residence in an assisted living facility is allowed

Exclusion criteria

Patients must not meet any of the following criteria:

1. Presence of other significant neurological or psychiatric disorders

2. History of clinically significant brain abnormality

3. Presence of cerebellar ataxia, choreoathetosis, early symptomatic autonomic dysfunction, or moderate to severe resting tremor, responsive to levodopa

4. Known history of serum or plasma progranulin level less than one standard deviation below the normal patient mean

5. Known presence of disease-associated mutation in TARDBP, GRN, CHMPB2, or VCP genes; or any other frontotemporal lobar degeneration causative genes not associated with underlying tau pathology

6. History of clinically significant hematological, endocrine, cardiovascular, renal, hepatic, or gastrointestinal disease

Endpoints (4)

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.

Coverage by outcome category

Behavior / neuropsychiatric
1
Neurodegeneration biomarkers
1
Fluid / digital biomarkers
1
Safety / tolerability / PK
1

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Assess the clinical effect of TPN-101 as measured by changes in score on the Progressive Supranuclear Palsy Rating Scale (PSPRS)

Time frame:48 weeks

categorical status, descriptive

Neurodegeneration biomarkers

1 endpoint
Secondary/protocol endpoint

Assess the pharmacodynamic effect of TPN-101 on neurodegeneration as measured by changes in the levels of CSF and blood neurofilament light (NfL)

Time frame:48 weeks

Neurofilament light (NfL)

ratio, descriptive

Fluid / digital biomarkers

1 endpoint
Secondary/protocol endpoint

Assess the pharmacokinetics of TPN-101 as measured by concentrations of TPN-101 in plasma and cerebrospinal fluid (CSF)

Time frame:48 weeks

concentration, descriptive

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Assess the safety and tolerability of TPN-101 in patients with progressive supranuclear palsy (PSP)

Time frame:48 weeks

event count, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

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.