Novel Neuroimage Study in Tauopathies With Parkinsonism

NCT03386669 | Completed Phase 2

• 1 other identifier: 201601674A0
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinsonism

Keywords

18F-THK5351 PET; Tauopathies

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

F-18 AV-45 THK-5351

EXPERIMENTAL

F-18 AV-45 THK-5351 imaging

Drug: F-18

Interventions

F-18 DRUG

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.

Also known as: F-18 THK-5351, F-18 AV-45

F-18 AV-45 THK-5351

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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).
• 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).

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
• 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)

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital,Linkou

Taoyuan, Guishan Dist, 333, Taiwan

Location

MeSH Terms

Conditions

Parkinsonian Disorders; Tauopathies

Interventions

florbetapir

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: December 29, 2017
• Study Start: July 31, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

TW (1)