Trial Outcomes & Findings for Positron-Emission Tomography With Vesicular Monoamine Transporter Ligand ([18F]-DTBZ) In Healthy Elderly And Young Subjects (NCT NCT01838785)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

two years

Results posted on

2017-09-25

Participant milestones
Measure	18F-DTBZ AV-133 18F-DTBZ AV-133 imaging 18F-DTBZ AV-133
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Positron-Emission Tomography With Vesicular Monoamine Transporter Ligand ([18F]-DTBZ) In Healthy Elderly And Young Subjects

Baseline characteristics by cohort
Measure	18F-DTBZ AV-133 n=25 Participants 18F-DTBZ AV-133 imaging 18F-DTBZ AV-133
Age, Customized 20-29 years	5 participants n=5 Participants
Age, Customized 30-39 years	6 participants n=5 Participants
Age, Customized 40-49 years	7 participants n=5 Participants
Age, Customized 50-59 years	4 participants n=5 Participants
Age, Customized >60 years	3 participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment Taiwan	25 participants n=5 Participants

Timeframe: two years

Outcome measures
Measure	18F-DTBZ AV-133 n=25 Participants 18F-DTBZ AV-133 imaging 18F-DTBZ AV-133
Age-Dependent Change in Striatal 18F-DTBZ Uptake of Healthy Subjects.	0.05 SUVR Interval 0.05 to 1.0

Timeframe: two years

Population: A subgroup of 5 subjects receive additional scan for a test/retest reliability study

Outcome measures
Measure	18F-DTBZ AV-133 n=5 Participants 18F-DTBZ AV-133 imaging 18F-DTBZ AV-133
The Test/Retest 18F-DTBZ PET Measurements of VMAT2 Binding in Healthy Subjects.	2.35 SUVR Interval 1.18 to 3.94

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Chang Gung Memorial Hospital

Phone: 033281200