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18F-DTBZ for l Diagnosis of Parkinson's Disease and Monitoring the Severity of Disease by VMAT2 PET Imaging

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NJI90OKM, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01283347
First received: January 11, 2011
Last updated: December 25, 2012
Last verified: December 2012
History of Changes
  Purpose

The primary 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 normality. Secondary, the investigators will analyze the correlation between the 18F-DTBZ binding and the severity of disease of PD and the role of 18F-DTBZ PET in the monitoring disease severity.


Condition Intervention Phase
Parkinson's Disease
 Drug: 18F-DTBZ
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Phase II Study of 18F-DTBZ: The Differential Diagnosis of Parkinson's Disease and Monitoring the Severity of Disease by VMAT2 PET Imaging

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • To evaluate the sensitivity and specificity of 18F-DTBZ PET to the differential diagnosis of PD and normality for drug safety assessment [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]

    To evaluate the sensitivity and specificity of 18F-DTBZ PET to the differential diagnosis of PD and normality.

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



Secondary Outcome Measures:
  • To analyze the correlation between the regionally reduced 18F-DTBZ binding and the severity of disease of PD. [ Time Frame: 1 years ] [ Designated as safety issue: Yes ]
    The objectives of this study is to determine the sensitivity and specificity of 18F-DTBZ PET to the differential diagnosis of PD and normality, and to analyze the correlation between the regionally reduced 18F-DTBZ binding and the severity of disease of PD


Enrollment: 100
Study Start Date: May 2010
Study Completion Date: December 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 18F-DTBZ for Parkinson's Disease

25 age-matched healthy volunteers will be enrolled. For assessing the correlation between the 18F-DTBZ binding and the severity of disease, the patients with PD will be divided into three groups according to their motor scores: mild, moderate, and advanced. We will enroll 25 patients in each group. 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.

 Drug: 18F-DTBZ

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

Other Name: 18F-DTBZ

Detailed Description:

25 age-matched healthy volunteers will be enrolled. For assessing the correlation between the 18F-DTBZ binding and the severity of disease, the patients with PD will be divided into three groups according to their motor scores: mild, moderate, and advanced. We will enroll 25 patients in each group. 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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Both genders and 50~80 years old.
  2. Written and dated informed consent by self or by legal representative, to be obtained before any of the study procedures
  3. Healthy male or female subjects with no evidence of significant neurologic impairment by history.
  4. Seventy-five PD subjects will be divided as three subgroups according to the severity of disease: mild (Modified Hoehn and Yahr stage 1 to 2), moderate (Modified Hoehn and Yahr stage 2.5 to 3), and advanced (Modified Hoehn and Yahr stage 4 to 5).
  5. All the PD subjects should be fulfilled the UK Parkinson's Disease Society Brain Bank criteria of "possible" or "probable" PD. The age of disease onset should be older than 50 years.

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.
  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283347

Locations
Taiwan
Chang Gung Memory Hpspital
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Chin-Song Lu Department of Neurological ,LIN KOU
  More Information

No publications provided

Responsible Party: NJI90OKM, Professor, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01283347     History of Changes
Other Study ID Numbers: 98-2160A
Study First Received: January 11, 2011
Last Updated: December 25, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by Chang Gung Memorial Hospital:
Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 16, 2013