NCT01003535

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.

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

Typical duration 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

October 26, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

July 4, 2012

Status Verified

July 1, 2012

Enrollment Period

2.2 years

First QC Date

October 26, 2009

Last Update Submit

July 3, 2012

Conditions

Parkinson´s DiseaseAcetylcholineSPECT

Keywords

Parkinson´s diseaseAcetylcholine receptors

Outcome Measures

Primary Outcomes (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

    1 time

Study Arms (1)

[123I]5-IA-85380 SPECT

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Parkinson´s disease

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, Saarland University

Homburg/Saar, Saarland, D-66421, Germany

Location

Related Publications (8)

  • Bucerius J, Joe AY, Schmaljohann J, Gundisch D, Minnerop M, Biersack HJ, Wullner U, Reinhardt MJ. Feasibility of 2-deoxy-2-[18F]fluoro-D-glucose- A85380-PET for imaging of human cardiac nicotinic acetylcholine receptors in vivo. Clin Res Cardiol. 2006 Feb;95(2):105-9. doi: 10.1007/s00392-006-0342-6. Epub 2006 Jan 19.

    PMID: 16598519BACKGROUND

  • Ding YS, Fowler JS, Logan J, Wang GJ, Telang F, Garza V, Biegon A, Pareto D, Rooney W, Shea C, Alexoff D, Volkow ND, Vocci F. 6-[18F]Fluoro-A-85380, a new PET tracer for the nicotinic acetylcholine receptor: studies in the human brain and in vivo demonstration of specific binding in white matter. Synapse. 2004 Sep 1;53(3):184-9. doi: 10.1002/syn.20051. No abstract available.

    PMID: 15236351BACKGROUND

  • Fujita M, Seibyl JP, Vaupel DB, Tamagnan G, Early M, Zoghbi SS, Baldwin RM, Horti AG, KoreN AO, Mukhin AG, Khan S, Bozkurt A, Kimes AS, London ED, Innis RB. Whole-body biodistribution, radiation absorbed dose, and brain SPET imaging with [123i]5-i-A-85380 in healthy human subjects. Eur J Nucl Med Mol Imaging. 2002 Feb;29(2):183-90. doi: 10.1007/s00259-001-0695-z.

    PMID: 11926380BACKGROUND

  • Fujita M, Ichise M, van Dyck CH, Zoghbi SS, Tamagnan G, Mukhin AG, Bozkurt A, Seneca N, Tipre D, DeNucci CC, Iida H, Vaupel DB, Horti AG, Koren AO, Kimes AS, London ED, Seibyl JP, Baldwin RM, Innis RB. Quantification of nicotinic acetylcholine receptors in human brain using [123I]5-I-A-85380 SPET. Eur J Nucl Med Mol Imaging. 2003 Dec;30(12):1620-9. doi: 10.1007/s00259-003-1320-0. Epub 2003 Oct 2.

    PMID: 14523584BACKGROUND

  • Fujita M, Ichise M, Zoghbi SS, Liow JS, Ghose S, Vines DC, Sangare J, Lu JQ, Cropley VL, Iida H, Kim KM, Cohen RM, Bara-Jimenez W, Ravina B, Innis RB. Widespread decrease of nicotinic acetylcholine receptors in Parkinson's disease. Ann Neurol. 2006 Jan;59(1):174-7. doi: 10.1002/ana.20688.

    PMID: 16374823BACKGROUND

  • Fukuyama H. Functional brain imaging in Parkinson's disease-overview. J Neurol. 2004 Oct;251 Suppl 7:vII1-3. doi: 10.1007/s00415-004-1702-7. No abstract available.

    PMID: 15505748BACKGROUND

  • Mamede M, Ishizu K, Ueda M, Mukai T, Iida Y, Fukuyama H, Saga T, Saji H. Quantification of human nicotinic acetylcholine receptors with 123I-5IA SPECT. J Nucl Med. 2004 Sep;45(9):1458-70.

    PMID: 15347712BACKGROUND

  • Obrzut SL, Koren AO, Mandelkern MA, Brody AL, Hoh CK, London ED. Whole-body radiation dosimetry of 2-[18F]Fluoro-A-85380 in human PET imaging studies. Nucl Med Biol. 2005 Nov;32(8):869-74. doi: 10.1016/j.nucmedbio.2005.06.005.

    PMID: 16253812BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Joerg Spiegel, M.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

October 26, 2009

First Posted

October 28, 2009

Study Start

January 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

July 4, 2012

Record last verified: 2012-07

Locations

DE(1)