---
title: Image Characteristic and Longitudinal Follow up of 18F-PMPBB3 (APN-1607) PET for Progressive Supranuclear Palsy
nct_id: NCT04541836
overall_status: UNKNOWN
sponsor: Chang Gung Memorial Hospital
study_type: OBSERVATIONAL
primary_condition: Progressive Supranuclear Palsy
countries: Taiwan
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04541836.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04541836"
ct_last_update_post_date: 2020-09-09
last_seen_at: "2026-05-12T07:20:56.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Image Characteristic and Longitudinal Follow up of 18F-PMPBB3 (APN-1607) PET for Progressive Supranuclear Palsy

**NCT ID:** [NCT04541836](https://clinicaltrials.gov/study/NCT04541836)

## Key Facts

- **Status:** UNKNOWN
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 28
- **Lead Sponsor:** Chang Gung Memorial Hospital
- **Conditions:** Progressive Supranuclear Palsy
- **Start Date:** 2020-06-15
- **Completion Date:** 2023-12-31
- **CT.gov Last Update:** 2020-09-09

## Brief Summary

The study will enroll 20 PSP and 8 normal subjects with complete neurological examination, 18F-PMPBB3 (APN-1607) PET and MRI assessment. To explore: (1) whether 18F-PMPBB3 (APN-1607) can detect the 4R tau protein in the brain of PSP patients; (2) whether 18F-PMPBB3 (APN-1607) can distinguish the clinical characteristics of PSP; (3) Whether the distribution of tau deposition is related to disease severity, progression, and prognosis.

## Detailed Description

Progressive supranuclear palsy (PSP), also known as Steele-Richardson-Olszewski syndrome, has a similar incidence in men and women. The pathophysiology of PSP is remaining unclear, but it is known to be related to the abnormal accumulation of 4R tau protein in the brain. Recently, new generation of novel radiotracer 18F-PMPBB3 (APN-1607), which can be labeled with 4R PHF-tau without significant off-target binding, has been successfully developed. The study will enroll 20 PSP and 8 normal subjects with complete neurological examination, 18F-PMPBB3 (APN-1607) PET and MRI assessment. To explore: (1) whether 18F-PMPBB3 (APN-1607) can detect the 4R tau protein in the brain of PSP patients; (2) whether 18F-PMPBB3 (APN-1607) can distinguish the clinical characteristics of PSP; (3) Whether the distribution of tau deposition is related to disease severity, progression, and prognosis. The research results will help to understand the potential of 18F-PMPBB3 (APN-1607) as a biomarker for diagnosis and therapeutic assessment tool for progressive nuclear paralysis as well as other tau proteinopathy.

## Eligibility

- **Minimum age:** 20 Years
- **Maximum age:** 90 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed.
2. Patients fulfill the criteria of NINDS-SPSP clinical criteria for the diagnosis of PSP "as possible" or "probably" PSP, and healthy volunteer with no clinically relevant finding on physical examination at screening visit.
3. Age range 20-90 years

Exclusion Criteria:

1. Implantation of metal devices including cardiac pacemaker, intravascular metal devices.
2. Major systemic diseases including coronary arterial disease, heart failure, uremia, hepatic failure, prominent strokes, acute myocardial infarction, poorly controlled diabetes, previous head injury, intracranial operation, hypoxia, sepsis or severe infectious diseases
3. Major psychiatric disorders, drug or alcohol abuse and major depression
4. Pregnant women or breast- feeding women
```

## Arms

- **healthy control** — healthy volunteer with no clinically relevant finding on physical examination at screening visit will receive one baseline 18F-PMPBB3 tau PET scan, and another follow up scan 1.5yr later.
- **PSP** — Patients fulfill the criteria of NINDS-SPSP clinical criteria for the diagnosis of PSP "as possible" or "probably" PSP will receive one baseline 18F-PMPBB3 tau PET scan, and another follow up scan 1.5yr later.

## Interventions

- **18F-PMPBB3** (DIAGNOSTIC_TEST) — single intravenous injection 5mCi 18F-PMPBB3 per scan

## Primary Outcomes

- **Tau Distribution Among Progressive Supranuclear Palsy (PSP), and Normal Subjects** _(time frame: 5 days)_ — Tau Distribution Among Progressive Supranuclear Palsy (PSP), and Normal Subjects Measured by Standardized Uptake Value Ratio (SUVR) as Assessed by 18F-PM-PBB3 tau PET Scan

## Secondary Outcomes

- **To assess disease severity in PSP** _(time frame: 5 days)_
- **To assess disease progression in PSP** _(time frame: 1.5 year)_
- **Blood pressure** _(time frame: 3 hours)_
- **Pulse** _(time frame: 3 hours)_
- **Respiration frequency** _(time frame: 3 hours)_
- **Adverse events collection** _(time frame: 5 days)_

## Locations (1)

- Chang Gung Memorial Hospital,Linkou, Taoyuan City, Guishan Dist, Taiwan — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.chang gung memorial hospital,linkou|taoyuan city|guishan dist|taiwan` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04541836.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04541836*  
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