NCT01038310

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

December 22, 2009

Last Update Submit

January 26, 2020

Conditions

Parkinson´s Disease

Keywords

Parkinson´s diseaseFP-CIT-SPECT

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology

Homburg/Saar, Saarland, D-66421, Germany

Location

Related Publications (4)

  • 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.

    PMID: 4272516BACKGROUND

  • 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.

    PMID: 9396871BACKGROUND

  • 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.

    PMID: 10830416BACKGROUND

  • 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. doi: 10.1136/jnnp.55.3.181.

    PMID: 1564476BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Jörg Spiegel, Coordinator

    Department of Neurology, Saarland University, Kirrberger Straße, D-66421 Homburg/Saar, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant medical director

Study Record Dates

First Submitted

December 22, 2009

First Posted

December 23, 2009

Study Start

January 1, 2010

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

January 28, 2020

Record last verified: 2020-01

Locations

DE(1)