NCT01838785

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2 healthy

Timeline
Completed

Started Jul 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

September 25, 2017

Completed
Last Updated

September 25, 2017

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

April 21, 2013

Results QC Date

February 6, 2017

Last Update Submit

August 25, 2017

Conditions

Healthy

Keywords

18F-DTBZ AV-133 imaging

Outcome Measures

Primary Outcomes (1)

  • Age-Dependent Change in Striatal 18F-DTBZ Uptake of Healthy Subjects.

    two years

Secondary Outcomes (1)

  • The Test/Retest 18F-DTBZ PET Measurements of VMAT2 Binding in Healthy Subjects.

    two years

Study Arms (1)

18F-DTBZ AV-133

EXPERIMENTAL

18F-DTBZ AV-133 imaging

Drug: 18F-DTBZ AV-133

Interventions

18F-DTBZ AV-133DRUG
18F-DTBZ AV-133

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female age 20 years to 80 years.
  • Subjects without significant neuropsychiatric disorder after evaluation by Neurologist.
  • 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).

You may not qualify if:

  • Pregnancy and breast feeding.
  • Significant recent (within 6 months) history of neurological (including stroke and brain trauma) or psychiatric disorder.
  • Alcohol or substance abuse within last year.
  • Parkinson's disease or other brain degenerative disease (spinocerebellar ataxia, Wilson's disease, hydrocephalus, multiple infarction, history of severe head injury or intracranial operation.
  • Unable to stay still in the MRI or PET scanner for 30 minutes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

florbenazine F 18

Results Point of Contact

Title
Dr. kun-Ju Lin
Organization
Chang Gung Memorial Hospital
lin4857@adm.cgmh.org.tw
033281200

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2013

First Posted

April 24, 2013

Study Start

July 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

September 25, 2017

Results First Posted

September 25, 2017

Record last verified: 2016-01