ALTROPANE® SPECT Imaging in Patients With Parkinson Disease

December 15, 2016 updated by: Danna Jennings, Molecular NeuroImaging

Optimizing the Performance of ALTROPANE® SPECT Imaging in Patients With Parkinson Disease

After a screening evaluation including baseline clinical laboratory testing, a physical and neurological evaluation, subjects will be asked to undergo an injection of ALTROPANE® followed by up to 60 minutes of serial dynamic imaging. Subjects will undergo a second injection of ALTROPANE® followed by up to 60 minutes of serial dynamic imaging within 2-6 weeks of the injection 1.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The underlying goal of this open label imaging study is to optimize the imaging outcome for ALTROPANE® in mild to moderate PD subjects. All study procedures will be conducted at the Institute for Neurodegenerative Disorders (IND) and Molecular NeuroImaging (MNI) in New Haven, CT. Subjects with PD (n=15) will be recruited to undergo ALTROPANE® SPECT. All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, a physical and neurological evaluation. Subjects will be asked to undergo an injection of ALTROPANE® followed by up to 60 minutes of serial dynamic imaging. Subjects will be asked to undergo a second imaging visit two-six weeks following the initial imaging visit to assess the reproducibility of the imaging outcome. The imaging analyses will be performed by an image-processing specialist who will remain masked to clinical severity. The primary imaging outcome measure will be the brain regional distribution volumes expressed as a target region to occipital ratio. Striatal regions of interests for caudate and putamen will be defined and placement standardized based on previously optimized region placement protocols. Imaging data will also be analyzed using an automated objective striatal analysis software package.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Molecular NeuroImaging

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The participant is 30 years or older at time of PD diagnosis.
  • Written informed consent is obtained.
  • Participants have a clinical diagnosis of idiopathic Parkinson's disease of < 7 years.
  • Hoehn and Yahr stages I-III.
  • Negative drug screen

Exclusion Criteria:

  • The participant has atypical or drug-induced Parkinson's disease.
  • The participant has dementia.
  • The participant has a clinically significant clinical laboratory value and/or clinically significant unstable medical or psychiatric illness.
  • Treatment within the six months prior to screening with bupropion, methylphenidate, reserpine, alpha methyldopa, or amphetamine.
  • The participant has a history of alcohol, narcotic, or any other drug abuse within the past 2 years.
  • The participant has received an investigational drug within 60 days of screening visit.
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ALTROPANE®
ALTROPANE® dosing
Drug: ALTROPANE®
ALTROPANE® SPECT imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Optimize ALTROPANE® dosing and the image acquisition protocol to develop a quantitative imaging outcome that would enhance ALTROPANE® reliability, ease of use and ease of analysis.
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate a state-of-art automated objective striatal analysis tool for ALTROPANE® and to test the reliability of these quantitative outcomes.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Molecular NeuroImaging

Collaborators

Institute for Neurodegenerative Disorders

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

November 6, 2006

First Submitted That Met QC Criteria

November 6, 2006

First Posted (ESTIMATE)

November 8, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

December 16, 2016

Last Update Submitted That Met QC Criteria

December 15, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALTROPANE dosing

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe