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ALTROPANE® SPECT Imaging in Patients With Parkinson Disease

This study has been completed.
Institute for Neurodegenerative Disorders
Information provided by (Responsible Party):
Danna Jennings, Molecular NeuroImaging Identifier:
First received: November 6, 2006
Last updated: December 15, 2016
Last verified: December 2016
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
Phase 2

Study Type: Interventional
Study Design: 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 ]

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 ]

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®

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.

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00397228

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

Responsible Party: Danna Jennings, Principal Investigator, Molecular NeuroImaging Identifier: NCT00397228     History of Changes
Other Study ID Numbers: ALTROPANE dosing
Study First Received: November 6, 2006
Last Updated: December 15, 2016

Keywords provided by Molecular NeuroImaging:
dopamine transporter

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents processed this record on May 25, 2017