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

Condition	Intervention	Phase
Parkinsonian Syndrome	Procedure: [123I]ß CIT and SPECT imaging	Phase II

Further Study Details: 

Primary Outcomes: - Comparison of the imaging diagnosis, based on visual analysis and quantitative analysis, to the clinical diagnosis of the investigator blinded to the imaging results.
Secondary Outcomes: Comparison of the DAT imaging diagnosis, initial diagnosis by the movement disorder experts and referral neurologist diagnosis to the ''''gold standard'''' diagnosis.
Expected Total Enrollment:  250

• 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.

Ages Eligible for Study:  22 Years and above,  Genders Eligible for Study:  Both

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 ECG.

Please refer to this study by ClinicalTrials.gov identifier  NCT00129675

Debbie Ruotolo      203-401-4300    druotolo@indd.org

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

Study chairs or principal investigators

Danna L Jennings, MD,  Principal Investigator,  Institute for Neurodegenerative Disorders   

Study ID Numbers:  Query-PD Study
Last Updated:  August 11, 2005
Record first received:  August 11, 2005
ClinicalTrials.gov Identifier:  NCT00129675
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23