Trial Outcomes & Findings for Long-Term Vesicular Monoamine Transporter II Imaging and Clinical Assessment of Parkinson's Disease Progression (NCT NCT01556100)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

three years

Results posted on

2017-12-15

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	40
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Long-Term Vesicular Monoamine Transporter II Imaging and Clinical Assessment of Parkinson's Disease Progression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	18F-DTBZ AV-133 n=34 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	55.08 years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment Taiwan	34 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	18F-DTBZ AV-133 n=34 Participants 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.
Change in 18F-DTBZ Uptake in a Cohort of Parkinson's Disease Patients From Baseline to Month 36	12.95 SUVR Interval 1.74 to 24.16

SECONDARY outcome

Timeframe: three years

Population: A subgroup of 10 subjects receive additional scan for a test/retest reliability study

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.

Outcome measures

Outcome measures
Measure	18F-DTBZ AV-133 n=10 Participants 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.
To Determine the Test/Retest 18F-DTBZ PET Measurements of Vesicular Monoamine Transporter II Binding in PD Patients.	12.95 g/mL Interval 1.74 to 24.16

Adverse Events

18F-DTBZ AV-133

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. kun-Ju Lin

Chang Gung Memorial Hospital

Phone: 033281200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place