NCT04541836

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 9, 2020

Status Verified

August 1, 2020

Enrollment Period

3.5 years

First QC Date

August 31, 2020

Last Update Submit

September 8, 2020

Conditions

Progressive Supranuclear Palsy

Keywords

tauopathyProgressive Supranuclear PalsyF-18 APN1607 PETF-18 PMPBB3 PET

Outcome Measures

Primary Outcomes (1)

  • Tau Distribution Among Progressive Supranuclear Palsy (PSP), and Normal Subjects

    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

    5 days

Secondary Outcomes (6)

  • To assess disease severity in PSP

    5 days

  • To assess disease progression in PSP

    1.5 year

  • Blood pressure

    3 hours

  • Pulse

    3 hours

  • Respiration frequency

    3 hours

  • +1 more secondary outcomes

Study Arms (2)

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.

Diagnostic Test: 18F-PMPBB3

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.

Diagnostic Test: 18F-PMPBB3

Interventions

18F-PMPBB3DIAGNOSTIC_TEST

single intravenous injection 5mCi 18F-PMPBB3 per scan

Also known as: 18F-APN-1607, 18F-MNI-958, 18F-APN-0000455
PSPhealthy control

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

PSP patient will be enrolled from primary care clinic or hospital, control (healthy subjects) will be enrolled from community.

You may qualify if:

  • Written informed consent must be obtained before any assessment is performed.
  • 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.
  • Age range 20-90 years

You may not qualify if:

  • Implantation of metal devices including cardiac pacemaker, intravascular metal devices.
  • 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
  • Major psychiatric disorders, drug or alcohol abuse and major depression
  • Pregnant women or breast- feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital,Linkou

Taoyuan, Guishan Dist, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Supranuclear Palsy, ProgressiveTauopathies

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersOphthalmoplegiaOcular Motility DisordersCranial Nerve DiseasesNeurodegenerative DiseasesParalysisNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Kun-Ju Lin, MD PhD

CONTACT

886-3-3281200kunjulin@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2020

First Posted

September 9, 2020

Study Start

June 15, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 9, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

no plan

Locations

TW(1)