Prognostic Value of FP-CIT-SPECT in Parkinson´s Disease

This study has been completed.
Sponsor:
Information provided by:
Saarland University
ClinicalTrials.gov Identifier:
NCT01038310
First received: December 22, 2009
Last updated: July 22, 2010
Last verified: July 2010
  Purpose

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.


Condition
Parkinson´s Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prognostic Value of FP-CIT-SPECT in Patients With Parkinson´s Disease

Resource links provided by NLM:


Further study details as provided by Saarland University:

Primary Outcome Measures:
  • 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. [ Time Frame: Between 4 and 7 years after FP-CIT-SPECT ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: January 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Detailed Description:

Background of this study:

Parkinson´s disease (PD) is a degenerative disorder of the nervous system. In PD, mainly the presynaptic dopaminergic neurons are affected: The dopamine synthesis as well as the active transport of dopamine into the synaptic gap by presynaptic dopamine transporters (DAT) is reduced. First parkinsonian symptoms occur when the concentration of dopamine within the basal ganglia is reduced by at least 80 per cent (Bernheimer et al. 1973). The reduced DAT density represents a typical phenomenon of PD. The DAT density can be measured by means of nuclear medicine methods: the tracer FP-CIT (Fluoropropyl-Carbomethoxy-Iodophenyl-Tropane) has a high affinity to presynaptic DAT (Booij et al. 1998). PD patients show a significantly lower striatal FP-CIT uptake than healthy controls. Therefore FP-CIT SPECT supports the diagnosis of PD (Benamer et al. 2000).

Aims of this study:

To test the predictive value of FP-CIT-SPECT concerning the clinical course of PD.

Study protocol:

In this study we now (time 2) examine 25 PD patients who where diagnosed as having PD and who underwent FP-CIT-SPECT in the years 2003 up to 2006 (time 1). At both times - time 1 and time 2 - the part III (motor part) of the Unified Parkinson´s Disease Rating Score (UPDRS-Score) was / will be performed in the "Off" state. Furthermore, at time 2 the CERAD examination will be performed. 25 patients have to be included, if a correlation coefficient r = 0.5, an error 1st order = 0.05 and an error 2nd order = 0.20 are assumed.

We intend to answer the following questions:

  1. Is there a correlation between the DAT density - measured between 2003 and 2006 - and the then (time 1) clinical symptoms hypokinesia, rigidity, resting tremor, postural tremor (measured by the motor part of the UPDRS scale)?
  2. Is there a correlation between the DAT density - measured between 2003 and 2006 - and the actual (year 2010, time 2) clinical symptoms hypokinesia, rigidity, resting tremor, postural tremor?
  3. Is there a correlation between the DAT density - measured between 2003 and 2006 - and the change of clinical symptoms hypokinesia, rigidity, resting tremor, postural tremor 2003-2006 versus 2010 (delta = time 2 - time 1).
  4. Is there a correlation between the DAT density - measured between 2003 and 2006 - and the actual (year 2010, time 2) cognitive functions (measured by the CERAD)?
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Parkinson´s disease who underwent FP-CIT-SPECT in the years between 2003 and 2006.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01038310

Locations
Germany
Department of Neurology
Homburg/Saar, Saarland, Germany, D-66421
Sponsors and Collaborators
Saarland University
Investigators
Principal Investigator: Jörg Spiegel, Coordinator Department of Neurology, Saarland University, Kirrberger Straße, D-66421 Homburg/Saar, Germany
  More Information

Publications:
Responsible Party: Jörg Spiegel, M.D., assistant medical director, Department of Neurology, Saarland University, Kirrberger Strasse, D-66421 Homburg/Saar, Germany
ClinicalTrials.gov Identifier: NCT01038310     History of Changes
Other Study ID Numbers: JoergSpiegel2
Study First Received: December 22, 2009
Last Updated: July 22, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Saarland University:
Parkinson´s disease
FP-CIT-SPECT

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 July 24, 2014