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Completed

NCT Number: NCT01283347

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

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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chang Gung Memory Hpspital

Taoyuan, 333, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Both genders and 50~80 years old.
  • Written and dated informed consent by self or by legal representative, to be obtained before any of the study procedures
  • Healthy male or female subjects with no evidence of significant neurologic impairment by history.
  • 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).
  • 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

  • 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.
  • Any subject who has a clinically significant abnormal laboratory values, and/or clinically significant or unstable medical or psychiatric illness.
  • History of drug or alcohol abuse within the last year, or prior prolonged history of abuse.
  • History or presence of QTc prolongation.
  • History of intracranial operation, including thalamotomy, pallidotomy, and/or deep brain stimulation.
  • 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.
  • Patients who have the evidence of secondary

Treatment and study plan

18F-DTBZ

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

Primary outcomes

  1. 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

    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 outcomes

  1. To analyze the correlation between the regionally reduced 18F-DTBZ binding and the severity of disease of PD.

    Time frame: 1 years

    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

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Phase II Study of 18F-DTBZ: The Differential Diagnosis of Parkinson's Disease and Monitoring the Severity of Disease by VMAT2 PET Imaging

Acronym: 8F-DTBZ

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 26, 2011
Registry last updated
Dec 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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