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Imaging Non-motor Symptoms of Parkinson's Disease by Novel 18F-DTBZ and Florbetapir F-18 PET

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
18F- DTBZ
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinson's Disease focused on measuring 18F-DTBZ

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

1.10 healthy subjects : i. Male or female subjects, age range 20~80. ii. Subjects have no known neurological or psychiatric disease. However, mild peripheral neuropathies, such as entrapment syndrome or sciatica are allowed.iii. Subjects who provide a written informed consent prior to study entry.

2.30 subjects with a diagnosis of PD : i. Male or female patients, age range 20~80. ii. Patients should be fulfilled "UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria" as "PD". (Appendix I).iii. Patients should not have any clinical evidence of dementia or ICD. iv. 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).

3.30 subjects with a diagnosis of PD with dementia : i. Male or female patients, age range 20~80.ii. Patients should be fulfilled the "Movement Disorders Society diagnostic criteria of PDD as "possible" or "probable" PDD (Emre, 2006). (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).iv. 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).

4.20 subjects with a diagnosis of AD : i. Male or female patients, age range 20~80. ii. Patients should be fulfilled the "DSM-IV-TR Diagnostic criteria for Alzheimer's Disease" as AD. (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).iv. 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).

5.30 subjects with a diagnosis of PD with ICD : i. Male or female patients, age range 20~80. ii. Patients should be fulfilled one of the diagnostic criteria or definition in these ICDs: pathological gambling, hypersexuality, compulsive shopping, compulsive eating, punding, and compulsive medication use (Voon, 2009). (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).iv. 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.
  3. History of drug or alcohol abuse within the last year, or prior prolonged history of abuse.
  4. History of intracranial operation, including thalamotomy, pallidotomy, and/or deep brain stimulation.
  5. 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.
  6. Any evidence of secondary parkinsonism (multiple infarcts, intoxication, and hydrocephalus, etc) or other neurodegenerative diseases (multiple system atrophy, progressive supranuclear palsy).
  7. History of allergy to radioligands that contain 18F isotope.

Sites / Locations

  • Chang Gung Memory Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F- DTBZ for Parkinson's Disease

Arm Description

This study will compare the amyloid deposition of brain by florbetapir F-18 PET imaging and monoaminergic function by18F- DTBZ PET in 10 NC group, 30 PD group, 30 PDD group, 20 AD group. We will also analyze monoaminergic function by18F- DTBZ PET in 30 PDI group. Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping, healthy subjects, PD, PDD, and AD patients will have 4 visits in this study. PDI patients 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.

Outcomes

Primary Outcome Measures

To compare the amyloid deposition of brain by florbetapir F-18 PET imaging and monoaminergic function by18F- DTBZ PET
To compare the amyloid deposition of brain by florbetapir F-18 PET imaging and monoaminergic function by18F- DTBZ PET in NC group, PD group, PDD group, AD group. During this study, subjects will receive a single i.v. administration of approximately 370MBq (10 mCi) florbetapir F-18 immediately prior to imaging.

Secondary Outcome Measures

Full Information

First Posted
January 15, 2014
Last Updated
January 11, 2016
Sponsor
Chang Gung Memorial Hospital
Collaborators
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT02039024
Brief Title
Imaging Non-motor Symptoms of Parkinson's Disease by Novel 18F-DTBZ and Florbetapir F-18 PET
Official Title
Imaging Non-motor Symptoms of Parkinson's Disease by Novel 18F-DTBZ and Florbetapir F-18 PET
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
National Science Council, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this protocol is to investigate the monoaminergic (dopamine、serotonin、and norepinephrine ) nervous system and amyloid deposition in Parkinson's disease patients with non-motor symptoms (focus on impulse control disorders and dementia) by novel 18F-DTBZ and Florbetapir F-18 PET imaging. This study will compare the amyloid deposition of brain by florbetapir F-18 PET imaging and monoaminergic function by18F- DTBZ PET in NC group, PD group, PDD group, AD group. Investigators will also analyze monoaminergic function by18F- DTBZ PET in PDI group.
Detailed Description
Study duration is expected to be completed in a period of 3 year. This study will compare the amyloid deposition of brain by florbetapir F-18 PET imaging and monoaminergic function by18F- DTBZ PET in 10 age-matched healthy subjects (NC group), 30 PD patients without dementia/ICD (PD group), 30 PD patients with dementia (PDD group), and 20 patients with dementia (AD group). We will also analyze monoaminergic function by18F- DTBZ PET in 30 PD patients with ICD (PDI group). Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping, healthy subjects, PD, PDD, and AD patients will have 4 visits in this study ,as one screening visit, one florbetapir F-18 imaging visit, one 18F-DTBZ imaging visit, and one safety evaluation.PDI patients will have 3 visits in this study, as one screening visit, one 18F-DTBZ imaging visit, and one safety evaluation. Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
18F-DTBZ

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18F- DTBZ for Parkinson's Disease
Arm Type
Experimental
Arm Description
This study will compare the amyloid deposition of brain by florbetapir F-18 PET imaging and monoaminergic function by18F- DTBZ PET in 10 NC group, 30 PD group, 30 PDD group, 20 AD group. We will also analyze monoaminergic function by18F- DTBZ PET in 30 PDI group. Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping, healthy subjects, PD, PDD, and AD patients will have 4 visits in this study. PDI patients 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.
Intervention Type
Drug
Intervention Name(s)
18F- DTBZ
Intervention Description
During this study, subjects will receive a single i.v. administration of approximately 370MBq (10 mCi) 18F- DTBZ immediately prior to imaging. The dosage of DTBZ is 10 nmole. The effective dose in human body is about 5.6 mSV. During this study, subjects will receive a single i.v. administration of approximately 370MBq (10 mCi) florbetapir F-18 immediately prior to imaging. The dosage of DTBZ is 10 nmole. The effective dose in human body is about 5.6 mSV. 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 (Lin 2010).
Primary Outcome Measure Information:
Title
To compare the amyloid deposition of brain by florbetapir F-18 PET imaging and monoaminergic function by18F- DTBZ PET
Description
To compare the amyloid deposition of brain by florbetapir F-18 PET imaging and monoaminergic function by18F- DTBZ PET in NC group, PD group, PDD group, AD group. During this study, subjects will receive a single i.v. administration of approximately 370MBq (10 mCi) florbetapir F-18 immediately prior to imaging.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1.10 healthy subjects : i. Male or female subjects, age range 20~80. ii. Subjects have no known neurological or psychiatric disease. However, mild peripheral neuropathies, such as entrapment syndrome or sciatica are allowed.iii. Subjects who provide a written informed consent prior to study entry. 2.30 subjects with a diagnosis of PD : i. Male or female patients, age range 20~80. ii. Patients should be fulfilled "UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria" as "PD". (Appendix I).iii. Patients should not have any clinical evidence of dementia or ICD. iv. 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). 3.30 subjects with a diagnosis of PD with dementia : i. Male or female patients, age range 20~80.ii. Patients should be fulfilled the "Movement Disorders Society diagnostic criteria of PDD as "possible" or "probable" PDD (Emre, 2006). (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).iv. 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). 4.20 subjects with a diagnosis of AD : i. Male or female patients, age range 20~80. ii. Patients should be fulfilled the "DSM-IV-TR Diagnostic criteria for Alzheimer's Disease" as AD. (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).iv. 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). 5.30 subjects with a diagnosis of PD with ICD : i. Male or female patients, age range 20~80. ii. Patients should be fulfilled one of the diagnostic criteria or definition in these ICDs: pathological gambling, hypersexuality, compulsive shopping, compulsive eating, punding, and compulsive medication use (Voon, 2009). (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).iv. 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: 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 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. Any evidence of secondary parkinsonism (multiple infarcts, intoxication, and hydrocephalus, etc) or other neurodegenerative diseases (multiple system atrophy, progressive supranuclear palsy). History of allergy to radioligands that contain 18F isotope.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Hsin Weng
Organizational Affiliation
Chang Gung Memory Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memory Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

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Imaging Non-motor Symptoms of Parkinson's Disease by Novel 18F-DTBZ and Florbetapir F-18 PET

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