Long-Term Vesicular Monoamine Transporter II Imaging and Clinical Assessment of Parkinson's Disease Progression

Chang Gung Medical Foundation

Status and phase

Completed

Phase 2

Conditions

Parkinson Disease

Treatments

Drug: 18F-DTBZ AV-133

Study type

Interventional

Funder types

Other

Identifiers

NCT01556100

99-3989A

Details and patient eligibility

About

A total 40 PD subjects will be included in this study. PD 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.

Full description

The primary objective of this protocol is to assess the rate of change in striatal 18F-DTBZ uptake in a cohort of Parkinson's disease patients.

This study is expected to be completed in a period of 4 years.

Enrollment

40 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female age 20 years to 80 years.
Patients should be fulfilled Criteria of diagnosis of Parkinson disease of "possible" or "probable" PD1.
Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent)

Exclusion criteria

Significant recent (within 6 months) history of neurological (including stroke and brain trauma) or psychiatric disorder.
Alcohol or substance abuse.
History or presence of QTc prolongation. (>500msec)
History of intracranial operation, including thalamotomy, pallidotomy, and/or deep brain stimulation.
Unable to stay still in the MRI or PET scanner for 30 minutes.
Pregnancy and breast feeding.
Hepatic dysfunction with liver function test (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) of > 3x the upper limit of normal