Development of Imaging, Clinical and Biochemical Bio-Markers for Parkinson's Disease - Full Text View

Sponsor:	Institute for Neurodegenerative Disorders
Collaborators:	Department of Defense Molecular NeuroImaging
Information provided by (Responsible Party):	Danna Jennings, MD, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier:	NCT00315250

Purpose

We propose to build on preliminary data evaluating non-dopaminergic/non-motor clinical biomarkers to more fully assess these markers at the threshold of Parkinson disease (PD).

Development of reliable biomarkers for both dopaminergic and non-dopaminergic manifestations of Parkinson disease (PD) and related disorders may dramatically accelerate research on PD etiology, pathophysiology, and therapeutics. Biomarkers are broadly defined as characteristics that are objectively measured and evaluated as indicators of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention. Specific biomarkers may be useful at the onset of neurodegeneration, the onset of disease, and/or to mark disease progression.

Condition	Intervention	Phase
Parkinson's Disease Parkinsonian Syndrome	Drug: [123I]β-CIT and SPECT imaging	Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Development of Imaging, Clinical and Biochemical Bio-Markers for Parkinson's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease Perry syndrome

MedlinePlus related topics: Degenerative Nerve Diseases Parkinson's Disease

U.S. FDA Resources

Further study details as provided by Institute for Neurodegenerative Disorders:

Primary Outcome Measures:

Assess the sensitivity and specificity of olfaction, upper limb kinematic behavior, cognition, voice, metabolomic, proteomic and gene expression profiling in categorizing Parkinson Syndrome (PS) vs non-PS defined by [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Correlate progression of biomarker outcomes for olfaction, upper limb kinematic behavior, cognition, voice, metabolomic and gene expression profiling with progression of PS defined by % change from baseline in putamen [123I]ß-CIT SPECT uptake. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
>30% age expected loss of [123I]ß-CIT SPECT uptake [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
* clinical exam by a movement disorders expert (blinded to any imaging data) after 12 months of subject follow-up [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment:	225
Study Start Date:	January 2006
Study Completion Date:	June 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: [123I]β-CIT and SPECT imaging To assess B-CIT and SPECT imaging	Drug: [123I]β-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]β-CIT SPECT imaging

Arms

Assigned Interventions

Experimental: [123I]β-CIT and SPECT imaging

To assess B-CIT and SPECT imaging

Drug: [123I]β-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]β-CIT
SPECT imaging

Detailed Description:

Two hundred patients who have undergone neurological evaluation by their general community neurologist and have a questionable diagnosis of PD will be recruited to participate in this study. Subjects will be referred by the neurologists to the Institute for Neurodegenerative Disorders (IND) in New Haven, CT.

All subjects will be clinically evaluated at IND by a two movement disorders experts. At the baseline visit all subjects will also undergo [123I]ß-CIT SPECT ANAM, voice acoustics, olfactory, Spiral and biochemical testing. Each movement disorders expert will make an initial clinical diagnosis at baseline and again within three months follow-up. At the three month visit one movement disorder expert will be provided the DAT imaging data and will review that data with the subjects and referral physician. The other movement disorders physician will remain blind to the imaging and all other biomarker data. The blinded movement disorders expert will provide a final clinical diagnosis at the 12 month follow-up visit, which will represent the 'gold standard' diagnosis in this study. Statistical analysis to determine the sensitivity and specificity of ANAM, voice acoustics, olfactory, Spiral and biochemical testing compared to [123I]ß-CIT SPECT, and the gold standard clinical diagnosis will be completed. All subjects with DAT deficit and 10% of those without DAT deficit will be asked to return for repeat evaluation at 24 months.

Eligibility

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

Criteria

Inclusion Criteria:

Older than 21
Any parkinsonian symptoms
Referral by community neurologist
Parkinsonian symptoms for less than 2 years duration.
Willingness to follow the study plan.

Exclusion Criteria:

Pregnancy
Significant medical disease including abnormalities on screening biochemical or hematological labs or abnormal electrocardiogram (ECG - tracing of the electrical activity of the heart)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315250

Locations

United States, Connecticut
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510

Sponsors and Collaborators

Institute for Neurodegenerative Disorders

Department of Defense

Molecular NeuroImaging

Investigators

Principal Investigator:

Danna Jennings, MD

Institute for Neurodegenerative Disorders

More Information

No publications provided

Responsible Party:	Danna Jennings, MD, Principal Investigator, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier:	NCT00315250 History of Changes
Other Study ID Numbers:	Query 3C
Study First Received:	April 14, 2006
Last Updated:	February 8, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Institute for Neurodegenerative Disorders:

Parkinson

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 February 09, 2012