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Completed

NCT Number: NCT01838785

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

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.

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Key information

Conditions

Healthy

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

18F-DTBZ AV-133

Drug

Primary outcomes

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

    Time frame: two years

Secondary outcomes

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

    Time frame: two years

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 24, 2013
Registry last updated
Sep 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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