NCT02952391

Brief Summary

Although PD is considered predominantly as a motor disease caused by loss of dopaminergic neurons, multiple studies indicate that cholinergic dysfunction already starts in early PD and is crucial for the development of dementia in addition to motor symptoms.Because of its crucial role in CNS functioning and neurodegenerative disorders, including PD, it is of great importance to get a better understanding of the cholinergic functioning in the brain. Pathways of acetylcholine synthesis, transport and release provide possible targets for in vivo imaging of the cholinergic system. However,previous approaches are considered as indirect biomarkers of cholinergic terminal integrity because they measure both pre- and post-synaptic expressions. The novel vesicular acetylcholine transporter (VAChT) tracer \[18F\]Fluoroethoxy-Benzovesamicol (\[18F\]FEOBV) provides a more direct measurement of presynaptic cholinergic function. The use of \[18F\]FEOBV as a Positron Emission Tomography (PET) imaging marker of cholinergic innervations has, however, only been studied in healthy human volunteers and no data is available on patients. With this study the differences in cholinergic function between PD patients and healthy aged-matched volunteers will be quantified. In addition the test-retest variability will be determined

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Last Updated

November 29, 2016

Status Verified

November 1, 2016

Enrollment Period

5 months

First QC Date

October 31, 2016

Last Update Submit

November 28, 2016

Conditions

Parkinson's Disease

Keywords

cognitioncholinergic system

Outcome Measures

Primary Outcomes (1)

  • [18F]FEOBV binding

    the difference in VAChT brain binding on a \[18F\]FEOBV PET-scan between PD patients and healthy control subjects.

    baseline

Secondary Outcomes (2)

  • Test-retest reliability

    one week

  • Neuropsychological performance

    baseline

Study Arms (2)

Parkinson's disease patients

patients with Parkinson's disease, between the ages of 45 and 65, with a disease duration of 3 - 10 years

Other: [18F] FEOBV PET scan

healthy control subjects

Healthy control subjects, between the ages of 45 and 65

Other: [18F] FEOBV PET scan

Interventions

[18F] FEOBV PET scanOTHER

Cholinergic PET scan with the tracer \[18F\]Fluoroethoxybenzovesamicol

Parkinson's disease patientshealthy control subjects

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Two groups of subjects will be included in the study: * Patients with Parkinson's disease * Age-matched healthy control subjects A total of 20 subjects will be included in the study, with 10 subjects in each group.

You may qualify if:

  • Diagnosis Parkinson's disease (for patient group only)
  • Disease duration between 3 and 10 years. (for patient group only)
  • Age between 45 - 65 years
  • Willingness to cooperate and sign written informed consent
  • Able and fit enough to participate in this study

You may not qualify if:

  • The refusal to be informed about an unforeseen clinical finding
  • Pregnant women, breast feeding
  • Participation in scientific research using radioactivity in the past 12 months , exceeding the maximum annual radiation dose
  • Anticoagulant medication, antiplatelet agents used in the 5d before the imaging visit
  • Contra-indication for MRI-scanning (metal parts in the body, red pigments in the skin as used in some tattoos)
  • Other neurological conditions, more specifically neurodegenerative disorders and brain lesions.
  • Treatment with deep brain stimulation
  • prior history of neurologic or psychiatric illness (healthy control group only)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9713 RB, Netherlands

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Teus van Laar, Prof. Dr.

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sygrid van der Zee, MSc

CONTACT

+3153614524s.van.der.zee01@umcg.nl

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr.

Study Record Dates

First Submitted

October 31, 2016

First Posted

November 2, 2016

Study Start

September 1, 2016

Primary Completion

February 1, 2017

Last Updated

November 29, 2016

Record last verified: 2016-11

Locations

NL(1)