Developing a Novel Imaging Biomarker in the Differential Diagnosis of Parkinson's Disease and Parkinsonism

NCT ID: NCT02059733

Last Updated: 2018-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2018-07-31

Brief Summary

This study will compare the brain uptake of 18F- DTBZ in 20 patients with PD, 20 patients with MSA, 20 patients with PSP, 20 patients with CBS, and 20 patients with VaP, 20 patients with ET, and 10 patients with DT.

Detailed Description

Study duration is expected to be completed in a period of 4 year. This study is a uncontrolled, open-label, non-randomized, parallel, and cross-sectional study. Total 130 subjects, including 20 patients with PD, 20 patients with MSA, 20 patients with PSP, 20 patients with CBS, 20 patients with VaP, 20 patients with ET, and 10 patients with DT, will be enrolled.

Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping, each subject will have 3 visits in this study, as one screening visit, one imaging visit, and one safety evaluation visit.

Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

18F-DTBZ for Parkinson's Disease and parkinsonism

This study will compare the brain uptake of 18F- DTBZ in 20 patients with PD, 20 patients with MSA, 20 patients with PSP, 20 patients with CBS, and 20 patients with VaP, 20 patients with ET, and 10 patients with DT.

Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping, each subject will have 3 visits in this study. Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.

Group Type: EXPERIMENTAL

18F-DTBZ

Intervention Type: DRUG

During this study, subjects will receive a single i.v. administration of approximately 10 mCi 18F-DTBZ immediately prior to imaging.

The proposed dose for this study is based on our phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG.

Interventions

18F-DTBZ

During this study, subjects will receive a single i.v. administration of approximately 10 mCi 18F-DTBZ immediately prior to imaging.

The proposed dose for this study is based on our phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

i. Male or female patients, age range 20~80. ii. Patients should be fulfilled "UK Parkinson's Disease Society Brain Bank Criteria for the Diagnosis of PD" (Appendix I).

iii. 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. Twenty subjects with a diagnosis of MSA whom must:

i. Male or female patients, age range 20~80. ii. Patients should be fulfilled the Consensus diagnostic criteria of "possible" or "probable" MSA14 (Appendix I).

iii. 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. Twenty subjects with a diagnosis of PSP whom must:

i. Male or female patients, age range 20~80. ii. Patients should be fulfilled the NINDS-SPSP clinical criteria for the diagnosis of PSP " as possible" or "probable" PSP55 (Appendix III).

iii. 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).

4. Twenty subjects with a diagnosis of CBS whom must:

i. Male or female patients, age range 20~80. ii. Patients should be fulfilled the"Mayo Clinic proposed criteria for the diagnosis for corticobasal syndrome"56 (Appendix I).

iii. 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).

5. Twenty subjects with a diagnosis of VaP whom must:

i. Male or female patients, age range 20~80. ii. Patients should be fulfilled the clinical diagnostic criteria of vascular parkinsonism. (Appendix I).

iii. 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).

6. Twenty subjects with a diagnosis of ET whom must:

i. Male or female patients, age range 20~80. ii. Patients should be fulfilled the "The Consensus Criteria of the MDS on Essential Tremor"30. (Appendix I).

iii. 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).

7. Ten subjects with a diagnosis of DT whom must:

i. Male or female patients, age range 20~80. ii. Patients should be fulfilled the "The Consensus Criteria of the MDS on Dystonic Tremor"30. (Appendix I).

iii. 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. Pregnant or becoming pregnant during the study (as documented by pregnancy testing at screening or at any date during the study according to the PI discretion) or current breast feeding..

2. Any subject who has a clinically significant abnormal laboratory values, and/or clinically significant or unstable medical or psychiatric illness.

i. Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances.

ii. Current clinically significant cardiovascular disease. (cardiac surgery or myocardial infarction within the last 6 months; unstable angina; decompensated congestive heart failure; significant cardiac arrhythmia; congenital heart disease.

3. History of drug or alcohol abuse within the last year, or prior prolonged history of abuse.

4. History or presence of QTc prolongation.

5. History of intracranial operation, including thalamotomy, pallidotomy, and/or deep brain stimulation.

6. Any documented abnormality in the brain by CT or MRI of brain, which might contribute to the motor function, such as hydrocephalus and encephalomalacia, will be excluded. Mild cortical atrophy and non-specific white matter changes will be allowed.

7. Patients who have the evidence of secondary parkinsonism or other neurodegenerative diseases, such as spinocerellar atrophy (SCA), Wilson's disease, hydrocephalus , serious head injury and definite history of neurotoxin exposure, are excluded.

8. History of allergy to radioligands that contain 18F isotope.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yi-Hsin Weng

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chang Gung Memory Hospital

Taoyuan District, , Taiwan

Countries

Taiwan

Other Identifiers

101-1273A

Identifier Type: -

Identifier Source: org_study_id