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Quantification of Cerebral Cholinergic Function in Parkinson´s Disease by Means of Nuclear Medicine Methods

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ClinicalTrials.gov Identifier: NCT01003535
Recruitment Status : Completed
First Posted : October 28, 2009
Last Update Posted : July 4, 2012
Sponsor:
Information provided by (Responsible Party):
Joerg Spiegel, Universität des Saarlandes

Brief Summary:

Parkinson´s disease is based on a Lewy body degeneration of cerebral and extracerebral neurons. This Lewy body degeneration includes cerebral cholinergic neurons besides dopaminergic neurons.

In previous studies the investigators found that some clinical parkinsonian symptoms - primarily hypokinesia and rigidity - significantly correlate with the dopaminergic nigrostriatal degeneration which was quantified by dopamine transporter imaging. In contrast to that, resting or postural parkinsonian tremor does not correlate with the dopaminergic nigrostriatal degeneration. Obviously further cerebral changes - for instance possible changes / degeneration of cerebral cholinergic neurons - contribute to parkinsonian tremor.

In this study the investigators apply cerebral 5-IA-85380-SPECT to quantify the local density of cerebral nicotinergic cholinergic receptors in patients with Parkinson´s disease. The investigators will correlate the results of cerebral 5-IA-85380-SPECT with the clinical parkinsonian main symptoms hypokinesia, rigidity and primarily resting and postural tremor. In particular, it is of interest whether changes of cerebral cholinergic neurons are involved in the generation of parkinsonian tremor.


Condition or disease
Parkinson´s Disease Acetylcholine SPECT

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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quantification of Cerebral Cholinergic Function in Patients With Parkinson´s Disease by Means of Nuclear Medicine Methods
Study Start Date : January 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


Group/Cohort
[123I]5-IA-85380 SPECT



Primary Outcome Measures :
  1. Correlation of density of acetylcholine receptors in distinct brain areas versus the clinical parameters resting tremor, postural tremor, hypokinesia and rigidity in patients with Parkinson´s disease [ Time Frame: 1 time ]


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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Parkinson´s disease
Criteria

Inclusion Criteria:

  • patients with Parkinson´s disease (after the UK Brain Bank criteria)
  • Hoehn and Yahr stage 1
  • age 50 - 75 years
  • non-smokers
  • informed consent to participate in the study

Exclusion Criteria:

  • pregnant or nursing women
  • no adequate contraception in women who are capable of childbearing
  • male patients living with fertile women without adequate contraception
  • smokers
  • actual or past drug or alcohol abuse
  • dementia (minimental state test < 25 points)
  • psychosis or antipsychotic medication in the last 12 months
  • cholinergic or anticholinergic medication
  • unstable or severe internal diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01003535


Locations
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Germany
Department of Neurology, Saarland University
Homburg/Saar, Saarland, Germany, D-66421
Sponsors and Collaborators
Universität des Saarlandes
Investigators
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Principal Investigator: Joerg Spiegel, M.D. Department of Neurology, Saarland University, Kirrberger Strasse, D-66421 Homburg/Saar, Germany
Publications:

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Responsible Party: Joerg Spiegel, M.D, Universität des Saarlandes
ClinicalTrials.gov Identifier: NCT01003535    
Other Study ID Numbers: JoergSpiegel1
First Posted: October 28, 2009    Key Record Dates
Last Update Posted: July 4, 2012
Last Verified: July 2012
Keywords provided by Joerg Spiegel, Universität des Saarlandes:
Parkinson´s disease
Acetylcholine receptors
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases