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CompletedPhase 2

A Study to Assess Tolerability, Safety, Pharmacokinetics and Effect of AZP2006 in Patients With PSP

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess Tolerability, Safety, Pharmacokinetics and Effect of AZP2006 on Cerebrospinal Fluid Biomarkers in 36 Patients With Progressive Supranuclear Palsy

Lead sponsor

Asset

AZP2006

Listed sites

3

Recruiting sites

-

Enrollment

36

actual

Study population

Frontotemporal dementia

Key I/E criterion

•Age 40-80

Primary endpoints

•Number and percentage of patients who prematurely discontinue from the study•Pharmacokinetics of AZP2006 in plasma, blood, and CSF

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

Org study IDAZP2006C04

NCT IDNCT04008355

Timeline

Milestones

Study first posted2019-07-05actual

Study start2020-06-22actual

Primary completion2022-07-18actual

Study completion2024-09-30actual

Last update posted2025-03-17actual

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

•Male and female patients with probable or possible PSP

•Patients must be stable with their medication for at least 30 days prior to the inclusion visit

Exclusion criteria

•Any history of clinically significant head trauma or cerebrovascular disease or recent history of substance abuse or alcohol abuse and deemed to be clinically significant by the Investigator.

•History of deep brain stimulator (DBS) surgery other than sham surgery for DBS clinical study.

Endpoints (14)

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

Fluid / digital biomarkers

13

Safety / tolerability / PK

1

Fluid / digital biomarkers

13 endpoints

Primary/protocol endpoint

The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF

Time frame:From Day 1 of Day 84 (12 weeks)

concentration, descriptive

Primary/protocol endpoint

The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF

Time frame:From Day 1 of Day 84 (12 weeks)

concentration, descriptive

Primary/protocol endpoint

The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF

Time frame:From Day 1 of Day 84 (12 weeks)

ratio, descriptive

Primary/protocol endpoint

The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF

Time frame:From Day 1 of Day 84 (12 weeks)

ratio, descriptive

Primary/protocol endpoint

The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF

Time frame:From Day 1 of Day 84 (12 weeks)

concentration, descriptive

Primary/protocol endpoint

The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF

Time frame:From Day 1 of Day 84 (12 weeks)

concentration, descriptive

Primary/protocol endpoint

The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF

Time frame:From Day 1 of Day 84 (12 weeks)

concentration, descriptive

Primary/protocol endpoint

The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF

Time frame:From Day 1 of Day 84 (12 weeks)

ratio, descriptive

Primary/protocol endpoint

The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF

Time frame:From Day 1 of Day 84 (12 weeks)

ratio, descriptive

Primary/protocol endpoint

The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF

Time frame:From Day 1 of Day 84 (12 weeks)

ratio, descriptive

Primary/protocol endpoint

The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF

Time frame:From Day 1 of Day 84 (12 weeks)

ratio, descriptive

Primary/protocol endpoint

The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF

Time frame:From Day 1 of Day 84 (12 weeks)

ratio, descriptive

Primary/protocol endpoint

The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF

Time frame:From Day 1 of Day 84 (12 weeks)

ratio, descriptive

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Number and percentage of patients who prematurely discontinue from the study due to adverse events (AEs)

Time frame:From Day 1 to Day 180

threshold achievement, event

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.