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

NCT ID: NCT01838785

Last Updated: 2017-09-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-07-31

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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18F-DTBZ AV-133

18F-DTBZ AV-133 imaging

Group Type EXPERIMENTAL

18F-DTBZ AV-133

Intervention Type DRUG

Interventions

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18F-DTBZ AV-133

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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99-4149A

Identifier Type: -

Identifier Source: org_study_id