Parkinson's DiseasePhase 2NCT02039024
Imaging Non-motor Symptoms of Parkinson's Disease by Novel 18F-DTBZ and Florbetapir F-18 PET
A Phase 2 study testing 18F- DTBZ in people with Parkinson's Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- 18F- DTBZ
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2012to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- 18F- DTBZ
- Keywords
- 18F-DTBZ
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F- DTBZDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| 18F- DTBZ for Parkinson's Disease | Experimental | 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. Receives: Drug: 18F- DTBZ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study startMar 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, NJI90OKM, Chang Gung Memorial Hospital
- Investigators
- Yi-Hsin Weng, Principal investigator, Chang Gung Memory Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039024
- Sponsor's protocol ID
- 100-4356A
- Status last verified
- Jan 2016
- First submitted
- 15 Jan 2014
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Non-motor Symptoms of Parkinson's Disease by Novel 18F-DTBZ and Florbetapir F-18 PET
- ClinicalTrials.gov ID
- NCT02039024
- Acronym / sponsor ID
- 100-4356A
- Conditions
- Parkinson's Disease
- Keywords
- 18F-DTBZ
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Mar 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F- DTBZ for Parkinson's Disease | Experimental | Drug: 18F- DTBZThis 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F- DTBZDuring 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). | Drug | 18F- DTBZ for Parkinson's Disease |
Primary outcome
To compare the amyloid deposition of brain by florbetapir F-18 PET imaging and monoaminergic function by18F- DTBZ PET
Time frame: 3 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Hsin Weng principal investigator
Chang Gung Memory Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 18F- DTBZ in people with Parkinson's Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the amyloid deposition of brain by florbetapir F-18 PET imaging and monoaminergic function by18F- DTBZ PET (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2016.