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Study of Individuals With Parkinson's Symptoms But in Whom There is Diagnostic Uncertainty

This study has been completed.
Sponsor:
Collaborator:
Molecular NeuroImaging
Information provided by (Responsible Party):
Danna Jennings, MD, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier:
NCT00129675
First received: August 11, 2005
Last updated: October 22, 2012
Last verified: October 2012
History of Changes
  Purpose

The overall goal of this study is to evaluate the use of dopamine transporter (DAT) imaging as a diagnostic tool in subjects with early parkinsonian symptoms, in whom Parkinson's disease (PD) or parkinsonian syndrome (PS) is suspected, but the diagnosis remains unclear from a clinical standpoint.


Condition Intervention Phase
Parkinsonian Syndrome
 Drug: [123I]ß CIT and SPECT imaging
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Development of a Imaging Marker for Parkinson's Disease Through Use of Dynamic SPECT Imaging With [123I] Beta-CIT in Individuals With Parkinson's Symptoms

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institute for Neurodegenerative Disorders:

Primary Outcome Measures:
  • Comparison of the imaging diagnosis, based on visual analysis and quantitative analysis, to the clinical diagnosis of the investigator blinded to the imaging results [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of the DAT imaging diagnosis, initial diagnosis by the movement disorder experts and referral neurologist diagnosis to the 'gold standard' diagnosis [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 169
Study Start Date: February 2003
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: [123I]ß CIT and SPECT imaging
To assess [123I]ß CIT and SPECT imaging
 Drug: [123I]ß CIT and SPECT imaging

Single Photon Emission Computed Tomography

SPECT imaging uses the single photon emissions from radioactive compounds that are (most commonly) injected into a patient and are metabolized by specific organs or body systems. SPECT imaging is performed by using a gamma camera to acquire multiple 2-D images (also called projections), from multiple angles. A computer is then used to apply a tomographic reconstruction algorithm to the multiple projections, yielding a 3-D dataset. This dataset may then be manipulated to show thin slices along any chosen axis of the body, similar to those obtained from other tomographic techniques, such as MRI, CT, and PET. The resulting SPECT images reflect body/organ function as opposed to specific anatomy of other imaging modalities such as CT or MRI.

Other Names:
  • [123I]ß CIT
  • SPECT imaging

Detailed Description:
  • Subjects will be referred to the Institute for Neurodegenerative Disorders (IND) by practicing general neurologists with genuine uncertainty regarding the subject's diagnosis.
  • Subjects with suspected PD or PS will be evaluated clinically and with DAT imaging, using b-CIT and SPECT. The DAT imaging procedure will take place over two days:
  • On the first day participants are injected with [123I]ß CIT, an investigational radioactive material that localizes in the brain. Study participants will also have a thorough neurologic examination and standard neuropsychological testing, including testing of memory, concentration, abstraction and visual spatial functions.
  • Twenty-four hours later study participants return to the Institute for Neurodegenerative Disorders where an investigational scanning procedure will be used to obtain SPECT (single photon emission computed tomography) images of the brain.
  • Subjects will be asked to return within 3 months following the imaging study to have a repeat neurological examination by the two study neurologists at IND.
  • Subjects will be asked to return at about 6 months and possibly again at one year following the imaging study for a final clinical evaluation by one of the study neurologists at IND.
  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >21
  • Any parkinsonian or extrapyramidal symptoms
  • Parkinsonian symptoms for < 2 years duration.
  • No significant abnormalities on screening laboratory studies including: CBC, Chem-20 and urinalysis.
  • Willingness to comply with study protocol.

Exclusion Criteria:

  • Pregnancy
  • Significant medical disease including abnormalities on screening biochemical or hematological labs or abnormal electrocardiogram (ECG).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00129675

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

No publications provided

Responsible Party: Danna Jennings, MD, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier: NCT00129675     History of Changes
Other Study ID Numbers: Query-PD Study
Study First Received: August 11, 2005
Last Updated: October 22, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Institute for Neurodegenerative Disorders:
parkinson
diagnosis

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

ClinicalTrials.gov processed this record on May 23, 2013