Parkinson Disease
Conditions
Keywords
18F-DTBZ AV-133 imaging
Brief summary
A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test.
Detailed description
The primary objective of this protocol is to assess the rate of change in striatal 18F-DTBZ uptake in a cohort of Parkinson's disease patients. This study is expected to be completed in a period of 4 years.
Interventions
DRUG18F-DTBZ AV-133
A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female age 20 years to 80 years. 2. Patients should be fulfilled Criteria of diagnosis of Parkinson disease of possible or probable PD1. 3. 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. Significant recent (within 6 months) history of neurological (including stroke and brain trauma) or psychiatric disorder. 2. Alcohol or substance abuse. 3. History or presence of QTc prolongation. (\>500msec) 4. History of intracranial operation, including thalamotomy, pallidotomy, and/or deep brain stimulation. 5. Unable to stay still in the MRI or PET scanner for 30 minutes. 6. Pregnancy and breast feeding. 7. Hepatic dysfunction with liver function test (alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\]) of \> 3x the upper limit of normal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 18F-DTBZ Uptake in a Cohort of Parkinson's Disease Patients From Baseline to Month 36 | three years | To expand the database of 18F-DTBZ PET imaging in Parkinson's Disease patients to refine the definition of a positive scan in patient with PD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Determine the Test/Retest 18F-DTBZ PET Measurements of Vesicular Monoamine Transporter II Binding in PD Patients. | three years | The test/retest reliability will be estimated from a subgroup of the study subjects (10 subjects) who receive additional scan within 4 weeks since baseline image. In order to refine the definition of a positive 18F-DTBZ in patient with PD as compared to healthy control, quantitative measurement will be used. The standard uptake value (SUV) of each brain regions will be calculated. The SUV is a widely used, simple PET quantifier, calculated as a ratio of tissue radioactivity concentration (e.g. in units kBq/ml) at time t, CPET(t) and injected dose (e.g. in units MBq) at the time of injection divided by body weight (e.g. in units kg).SUV = CPET(t) / (Injected dose / Patient's weight), t =90min, and the unit of SUV is g/ml. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 18F-DTBZ AV-133 18F-DTBZ AV-133 imaging
18F-DTBZ AV-133: A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test. | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | 18F-DTBZ AV-133 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants |
| Age, Continuous | 55.08 years |
| Region of Enrollment Taiwan | 34 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Change in 18F-DTBZ Uptake in a Cohort of Parkinson's Disease Patients From Baseline to Month 36
To expand the database of 18F-DTBZ PET imaging in Parkinson's Disease patients to refine the definition of a positive scan in patient with PD.
Time frame: three years
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 18F-DTBZ AV-133 | Change in 18F-DTBZ Uptake in a Cohort of Parkinson's Disease Patients From Baseline to Month 36 | 12.95 SUVR |
Secondary
To Determine the Test/Retest 18F-DTBZ PET Measurements of Vesicular Monoamine Transporter II Binding in PD Patients.
The test/retest reliability will be estimated from a subgroup of the study subjects (10 subjects) who receive additional scan within 4 weeks since baseline image. In order to refine the definition of a positive 18F-DTBZ in patient with PD as compared to healthy control, quantitative measurement will be used. The standard uptake value (SUV) of each brain regions will be calculated. The SUV is a widely used, simple PET quantifier, calculated as a ratio of tissue radioactivity concentration (e.g. in units kBq/ml) at time t, CPET(t) and injected dose (e.g. in units MBq) at the time of injection divided by body weight (e.g. in units kg).SUV = CPET(t) / (Injected dose / Patient's weight), t =90min, and the unit of SUV is g/ml.
Time frame: three years
Population: A subgroup of 10 subjects receive additional scan for a test/retest reliability study
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 18F-DTBZ AV-133 | To Determine the Test/Retest 18F-DTBZ PET Measurements of Vesicular Monoamine Transporter II Binding in PD Patients. | 12.95 g/mL |