Parkinson´s DiseaseNCT01038310
Prognostic Value of FP-CIT-SPECT in Parkinson´s Disease
An observational study of Parkinson´s Disease, run by Universität des Saarlandes at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson´s Disease
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Parkinson´s disease who underwent FP-CIT-SPECT in the years between 2003 and 2006.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Value of FP-CIT-SPECT in Patients With Parkinson´s Disease
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.
Read the 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:
- 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)?
- 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?
- 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).
- 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)?
- Conditions
- Parkinson´s Disease
- Keywords
- Parkinson´s disease, FP-CIT-SPECT
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Between 4 and 7 years after FP-CIT-SPECT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Parkinson´s DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joerg Spiegel, Universität des Saarlandes
- Investigators
- Jörg Spiegel, Coordinator, Principal investigator, Department of Neurology, Saarland University, Kirrberger Straße, D-66421 Homburg/Saar, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038310
- Sponsor's protocol ID
- JoergSpiegel2
- Status last verified
- Jan 2020
- First submitted
- 22 Dec 2009
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1016/0022-510x(73)90175-5. No abstract available.
PubMed 4272516Booij 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.
PubMed 9396871Benamer 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.
PubMed 10830416Hughes 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. doi: 10.1136/jnnp.55.3.181.
PubMed 1564476
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of FP-CIT-SPECT in Patients With Parkinson´s Disease
- ClinicalTrials.gov ID
- NCT01038310
- Acronym / sponsor ID
- JoergSpiegel2
- Conditions
- Parkinson´s Disease
- Keywords
- Parkinson´s disease, FP-CIT-SPECT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 23 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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)?
- 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?
- 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).
- 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)?
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Parkinson´s disease who underwent FP-CIT-SPECT in the years between 2003 and 2006.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Background: PubMed 4272516Bernheimer 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. doi: 10.1016/0022-510x(73)90175-5. No abstract available.
- Background: PubMed 9396871Booij 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.
- Background: PubMed 10830416Benamer 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.
- Background: PubMed 1564476Hughes 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. doi: 10.1136/jnnp.55.3.181.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jörg Spiegel, Coordinator principal investigator
Department of Neurology, Saarland University, Kirrberger Straße, D-66421 Homburg/Saar, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson´s Disease, run by Universität des Saarlandes at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01038310, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.