Novel Neuroimage Study in Tauopathies With Parkinsonism

The aims of this study are: 18F-THK5351 PET(Positron Emission Tomography) can defect the tau burden in PSP(Progressive Supranuclear Palsy) and CBS (Corticobasal syndrome)correlating with the known NFT(neurofibrillary tangles) topology of those diseases, 18F-THK5351 PET will differentiate subjects with suspected tauopathy due to PSP and CBS from subjects with suspected synucleinopathy due to idiopathic PD(Parkinson's disease). The distribution of PHF(paired helical filament) tau burden will correlate with specific motor and cognitive features of PSP and CBS; and regional PHF tau burden will be associated with cortical thinning. Together, these efforts will establish the potential for developing 18F-THK5351 PET imaging as a biomarker and diagnostic tool for the parkinsonian tauopathies.

Study Overview

• Status: Completed
• Conditions: Parkinsonism
• Intervention / Treatment: Drug: F-18

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Guishan Dist
    • Taoyuan City, Guishan Dist, Taiwan, 333
      • Chang Gung Memorial Hospital,Linkou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 20 subjects with a diagnosis of PD whom must:

   • Age ranges from 20-80 years
   • Patients should be fulfilled "UK(United Kingdom ) Parkinson's Disease Society Brain Bank Criteria for the diagnosis of PD", 2.11.1 Appendix I, (27)
   • Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).

2. 20 subjects with a diagnosis of PSP whom must:

   • Age ranges from 20-80 years
   • Patients fulfill the criteria of NINDS-SPSP(National Institute of Neurological Disorders and Stroke / Society for PSP) clinical criteria for the diagnosis of PSP "as possible" or "probably" PSP, 2.11.2 Appendix II, (28)
   • Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).

3. 20 subjects with a diagnosis of CBS whom must:

   • Age ranges from 20-80 years
   • Patients should be fulfilled the "Mayo Clinic proposed criteria for the diagnosis for corticobasal syndrome" , 2.11.3 Appendix III, (29)
   • Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).

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
5. Patients in whom MRI was contraindicated
6. History of severe allergic or anaphylactic reactions particularly to the tested drugs
7. Indication of impaired liver function as shown by an abnormal liver function profile at screening (eg. repeated values of aspartate aminotransferase [AST(aspartate aminotransferase)] and alanine aminotransferase [ALT(Alanine aminotransferase)] ≧ 3X(3 Times) the upper limit of normal values)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: F-18 AV-45 THK-5351; F-18 AV-45 THK-5351 imaging	Drug: F-18; Totally 60 subjects age 20-80 including 20 subjects with a diagnosis of PD,PSP,and CBS. For disease subjects, caregiver should be able to report activities of daily living and their mental status. Patient should be able to give informed consent or have a caregiver give consent with subject assent.; Other Names: F-18 THK-5351; F-18 AV-45

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To establish Tau image pattern for Tauopathies with parkinsonism.	Use ANOVA analysis(Analysis of variance) to significant differences in regional 18F-THK-5351 uptake between PSP, CBS and PD groups.	YEAR ONE

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2017
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: August 14, 2017
• First Submitted That Met QC Criteria: December 21, 2017
• First Posted (Actual): December 29, 2017

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Tauopathies; 18F-THK5351 PET
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Parkinsonian Disorders; Tauopathies
• Other Study ID Numbers: 201601674A0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No