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

NCT00129675 | Completed Phase 2

• 1 other identifier: Query-PD Study
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinsonian Syndrome

Keywords

parkinson; diagnosis

Outcome Measures

Primary Outcomes (1)

• Comparison of the imaging diagnosis, based on visual analysis and quantitative analysis, to the clinical diagnosis of the investigator blinded to the imaging results

  5 years

Secondary Outcomes (1)

• Comparison of the DAT imaging diagnosis, initial diagnosis by the movement disorder experts and referral neurologist diagnosis to the 'gold standard' diagnosis

  5 years

Study Arms (1)

[123I]ß CIT

EXPERIMENTAL

To assess \[123I\]ß CIT and SPECT imaging

Drug: [123I]ß CIT

Interventions

[123I]ß CIT DRUG

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.

Also known as: SPECT imaging

[123I]ß CIT

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy
• Significant medical disease including abnormalities on screening biochemical or hematological labs or abnormal electrocardiogram (ECG).

Sponsors & Collaborators

• Institute for Neurodegenerative Disorders: lead
• Molecular NeuroImaging: collaborator

Study Sites (1)

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Parkinsonian Disorders; Disease

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Danna L Jennings, MD

  Institute for Neurodegenerative Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Danna Jennings, MD

Study Record Dates

• First Submitted: August 11, 2005
• First Posted: August 12, 2005
• Study Start: February 1, 2003
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: July 16, 2014

Record last verified: 2014-07

Locations

US (1)