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

NCT01556100 | Completed Phase 2 Results DMC

• 1 other identifier: 99-3989A
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

18F-DTBZ AV-133 imaging

Outcome Measures

Primary Outcomes (1)

• Change in 18F-DTBZ Uptake in a Cohort of Parkinson's Disease Patients From Baseline to Month 36

  To expand the database of 18F-DTBZ PET imaging in Parkinson's Disease patients to refine the definition of a positive scan in patient with PD.

  three years

Secondary Outcomes (1)

• To Determine the Test/Retest 18F-DTBZ PET Measurements of Vesicular Monoamine Transporter II Binding in PD Patients.

  three years

Study Arms (1)

18F-DTBZ AV-133

EXPERIMENTAL

18F-DTBZ AV-133 imaging

Drug: 18F-DTBZ AV-133

Interventions

18F-DTBZ AV-133 DRUG

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.

18F-DTBZ AV-133

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Conditions

Parkinson Disease

Interventions

florbenazine F 18

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

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: March 6, 2012
• First Posted: March 16, 2012
• Study Start: November 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 15, 2017
• Results First Posted: December 15, 2017

Record last verified: 2016-11