ALTROPANE® SPECT Imaging in Patients With Parkinson Disease

This study has been completed.
Sponsor:
Collaborator:
Institute for Neurodegenerative Disorders
Information provided by (Responsible Party):
Danna Jennings, Molecular NeuroImaging
ClinicalTrials.gov Identifier:
NCT00397228
First received: November 6, 2006
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Parkinson Disease
Drug: ALTROPANE®
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Optimizing the Performance of ALTROPANE® SPECT Imaging in Patients With Parkinson Disease

Resource links provided by NLM:


Further study details as provided by Molecular NeuroImaging:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: November 2006
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALTROPANE®
ALTROPANE® dosing and SPECT imaging
Drug: ALTROPANE®
ALTROPANE® dosing and SPECT imaging
Other Name: ALTROPANE®

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00397228

Locations
United States, Connecticut
Molecular NeuroImaging
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Molecular NeuroImaging
Institute for Neurodegenerative Disorders
Investigators
Principal Investigator: Danna Jennings, MD Molecular NeuroImaging
  More Information

No publications provided

Responsible Party: Danna Jennings, Principal Investigator, Molecular NeuroImaging
ClinicalTrials.gov Identifier: NCT00397228     History of Changes
Other Study ID Numbers: ALTROPANE dosing
Study First Received: November 6, 2006
Last Updated: April 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Molecular NeuroImaging:
Parkinson
imaging
dopamine transporter

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on October 23, 2014