Clinical trial NCT00129675: Study of Individuals With Parkinson's Symptoms But in Whom There is Diagnostic Uncertainty
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinsonian Syndrome
Keywords: parkinson
diagnosis
Lead sponsor: Institute for Neurodegenerative Disorders
Sponsor class: OTHER
Collaborators: name: Molecular NeuroImaging
First posted: 2005-08-12
Enrollment: 169
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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 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).

Primary outcomes:
measure: Comparison of the imaging diagnosis, based on visual analysis and quantitative analysis, to the clinical diagnosis of the investigator blinded to the imaging results
timeFrame: 5 years
Secondary outcomes:
measure: Comparison of the DAT imaging diagnosis, initial diagnosis by the movement disorder experts and referral neurologist diagnosis to the 'gold standard' diagnosis
timeFrame: 5 years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Institute for Neurodegenerative Disorders
state: Connecticut
Study officials:
affiliation: Institute for Neurodegenerative Disorders
name: Danna L Jennings, MD
role: PRINCIPAL_INVESTIGATOR
References: