The Differential Diagnosis of Parkinson's Disease and Parkinsonism by Positron-emission Tomography

NCT ID: NCT01824056

Last Updated: 2013-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2013-07-31

Brief Summary

The objective of this protocol is to analyze the sensitivity and specificity of 18F-DTBZ PET to the differential diagnosis of Parkinson's disease (PD) and other parkinsonism disorders, including multiple system atrophy (MSA), corticobasal degeneration (CBD), and progressive supranuclear palsy (PSP).

Detailed Description

40 patients with PD, 40 patients with MSA, 20 patients with CBD, and 20 patients with PSP, 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,

Conditions

Parkinson's Disease

Keywords

18F-FDG

Study Design

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

Study Groups

18F-DTBZ for Parkinson's Disease

This study will compare the brain uptake of 18F- DTBZ in 40 patients with PD, 40 patients with MSA, 20 patients with CBD, and 20 patients with PSP . 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-FDG

Intervention Type: DRUG

During this study, subjects will receive a single i.v. administration of approximately 10 mCi 18F-FP-(+)-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-FDG

During this study, subjects will receive a single i.v. administration of approximately 10 mCi 18F-FP-(+)-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. Forty subjects with a diagnosis of PD whom must:

i.Male or female patients, age range 20~80. ii.Patients should be fulfilled Criteria of diagnosis of Parkinson disease8 of "possible" or "probable" 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. Forty 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 II).

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 of "possible" or "probable" PSP35 (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 CBD whom must:

i.Male or female patients, age range 20~80. ii.Patients should be fulfilled the Kumar's criteria of CBD36 (Appendix IV). 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 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, multiple infarction 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 (multiple infarcts, intoxication, and hydrocephalus, etc) or other neurodegenerative diseases, such as spinocerebellar atrophy (SCA), Wilson's disease, hydrocephalus, multiple infarction, serious head injury and definite history of neurotoxin exposure, are excluded.

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

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

NJI90OKM

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chang Gung Memory Hpspital

Taoyuan District, Taiwan, Taiwan

Countries

Taiwan

Other Identifiers

98-3626A

Identifier Type: -

Identifier Source: org_study_id