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Novel Neuroimage Study in Tauopathies With Parkinsonism

Primary Purpose

Parkinsonism

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
F-18
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinsonism focused on measuring 18F-THK5351 PET, Tauopathies

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Chang Gung Memorial Hospital,Linkou

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

F-18 AV-45 THK-5351

Arm Description

F-18 AV-45 THK-5351 imaging

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 14, 2017
Last Updated
January 25, 2021
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03386669
Brief Title
Novel Neuroimage Study in Tauopathies With Parkinsonism
Official Title
Novel Neuroimage Study in Tauopathies With Parkinsonism
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 31, 2017 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinsonism
Keywords
18F-THK5351 PET, Tauopathies

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
F-18 AV-45 THK-5351
Arm Type
Experimental
Arm Description
F-18 AV-45 THK-5351 imaging
Intervention Type
Drug
Intervention Name(s)
F-18
Other Intervention Name(s)
F-18 THK-5351, F-18 AV-45
Intervention Description
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.
Primary Outcome Measure Information:
Title
To establish Tau image pattern for Tauopathies with parkinsonism.
Description
Use ANOVA analysis(Analysis of variance) to significant differences in regional 18F-THK-5351 uptake between PSP, CBS and PD groups.
Time Frame
YEAR ONE

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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). 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). 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: 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 Patients in whom MRI was contraindicated History of severe allergic or anaphylactic reactions particularly to the tested drugs 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)
Facility Information:
Facility Name
Chang Gung Memorial Hospital,Linkou
City
Taoyuan City
State/Province
Guishan Dist
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

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Novel Neuroimage Study in Tauopathies With Parkinsonism

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