Healthy
Conditions
Keywords
18F-DTBZ AV-133 imaging
Brief summary
A total 25 healthy subjects will be included in this study. 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 possible age-dependent decline in striatal 18F-DTBZ uptake of healthy subjects. This study is expected to be completed in a period of 2 years.
Interventions
DRUG18F-DTBZ AV-133
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 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female age 20 years to 80 years. 2. Subjects without significant neuropsychiatric disorder after evaluation by Neurologist. 3. Subjects who provide a written informed consent prior to study entry. If the subject is incapable of informed consent, the caregiver may consent on behalf of the subject (the subject must still confirm assent).
Exclusion criteria
1. Pregnancy and breast feeding. 2. Significant recent (within 6 months) history of neurological (including stroke and brain trauma) or psychiatric disorder. 3. Alcohol or substance abuse within last year. 4. Parkinson's disease or other brain degenerative disease (spinocerebellar ataxia, Wilson's disease, hydrocephalus, multiple infarction, history of severe head injury or intracranial operation. 5. Unable to stay still in the MRI or PET scanner for 30 minutes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Age-Dependent Change in Striatal 18F-DTBZ Uptake of Healthy Subjects. | two years |
Secondary
| Measure | Time frame |
|---|---|
| The Test/Retest 18F-DTBZ PET Measurements of VMAT2 Binding in Healthy Subjects. | two years |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 18F-DTBZ AV-133 18F-DTBZ AV-133 imaging
18F-DTBZ AV-133 | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | 18F-DTBZ AV-133 |
|---|---|
| Age, Customized 20-29 years | 5 participants |
| Age, Customized 30-39 years | 6 participants |
| Age, Customized 40-49 years | 7 participants |
| Age, Customized 50-59 years | 4 participants |
| Age, Customized >60 years | 3 participants |
| Region of Enrollment Taiwan | 25 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Age-Dependent Change in Striatal 18F-DTBZ Uptake of Healthy Subjects.
Time frame: two years
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 18F-DTBZ AV-133 | Age-Dependent Change in Striatal 18F-DTBZ Uptake of Healthy Subjects. | 0.05 SUVR |
Secondary
The Test/Retest 18F-DTBZ PET Measurements of VMAT2 Binding in Healthy Subjects.
Time frame: two years
Population: A subgroup of 5 subjects receive additional scan for a test/retest reliability study
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 18F-DTBZ AV-133 | The Test/Retest 18F-DTBZ PET Measurements of VMAT2 Binding in Healthy Subjects. | 2.35 SUVR |