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

Phase 2

Completed

• Conditions: Healthy
• Interventions: Drug: 18F-DTBZ AV-133

• Registration Number: NCT01838785
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-04-21
• Study First Submitted QC: 2013-04-21
• Study First Posted: 2013-04-24
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2016-01
• Results First Submitted: 2017-02-06
• Results First Submitted QC: 2017-08-25
• Last Update Submitted: 2017-08-25
• Results First Posted: 2017-09-25
• Last Update Posted: 2017-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-DTBZ AV-133	18F-DTBZ AV-133	18F-DTBZ AV-133 imaging

Primary Outcome Measures

Name	Time	Method
Age-Dependent Change in Striatal 18F-DTBZ Uptake of Healthy Subjects.	two years

Secondary Outcome Measures

Name	Time	Method
The Test/Retest 18F-DTBZ PET Measurements of VMAT2 Binding in Healthy Subjects.	two years