Parkinson´s Disease Clinical Trial
Official title:
Prognostic Value of FP-CIT-SPECT in Patients With Parkinson´s Disease
NCT number | NCT01038310 |
Other study ID # | JoergSpiegel2 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2010 |
Est. completion date | July 2010 |
Verified date | January 2020 |
Source | Saarland University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The investigators aim to study whether the nuclear medicine method FP-CIT-SPECT (more details see below) allows to predict the further clinical course of Parkinson´s disease. Especially the investigators are interested in the motor and cognitive functions of the parkinsonian patients.
Status | Completed |
Enrollment | 25 |
Est. completion date | July 2010 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patients with Parkinson´s disease according to the Queen Square Brain Bank criteria (Hughes et al. 1992). - FP-CIT-SPECT at the Department of Nuclear Medicine, Saarland University, in the years between 2003 - 2006. - Informed consent. Exclusion Criteria: - Severe neurological (except Parkinson´s disease), psychiatric or internal diseases after the FP-CIT-SPECT. - Patients with a history of drug or alcohol abuse. - Patients with dementia (Mini-Mental-State-Test < 24 points). - Psychosis or antipsychotic treatment in the last 12 months. - Patients with pallidotomy or deep brain stimulation. |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Neurology | Homburg/Saar | Saarland |
Lead Sponsor | Collaborator |
---|---|
Saarland University |
Germany,
Benamer TS, Patterson J, Grosset DG, Booij J, de Bruin K, van Royen E, Speelman JD, Horstink MH, Sips HJ, Dierckx RA, Versijpt J, Decoo D, Van Der Linden C, Hadley DM, Doder M, Lees AJ, Costa DC, Gacinovic S, Oertel WH, Pogarell O, Hoeffken H, Joseph K, Tatsch K, Schwarz J, Ries V. Accurate differentiation of parkinsonism and essential tremor using visual assessment of [123I]-FP-CIT SPECT imaging: the [123I]-FP-CIT study group. Mov Disord. 2000 May;15(3):503-10. — View Citation
Bernheimer H, Birkmayer W, Hornykiewicz O, Jellinger K, Seitelberger F. Brain dopamine and the syndromes of Parkinson and Huntington. Clinical, morphological and neurochemical correlations. J Neurol Sci. 1973 Dec;20(4):415-55. — View Citation
Booij J, Busemann Sokole E, Stabin MG, Janssen AG, de Bruin K, van Royen EA. Human biodistribution and dosimetry of [123I]FP-CIT: a potent radioligand for imaging of dopamine transporters. Eur J Nucl Med. 1998 Jan;25(1):24-30. Erratum in: Eur J Nucl Med 1998 Apr;25(4):458. — View Citation
Hughes AJ, Daniel SE, Kilford L, Lees AJ. Accuracy of clinical diagnosis of idiopathic Parkinson's disease: a clinico-pathological study of 100 cases. J Neurol Neurosurg Psychiatry. 1992 Mar;55(3):181-4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation between striatal FP-CIT uptake (measured in the years 2003 - 2006) versus the then (time 1) and the actual (time 2) motor and cognitive functions. | Between 4 and 7 years after FP-CIT-SPECT |
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