Sponsor study identifier
observational
20
1 country
1
Study Start
September 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
Not reported
Date not reportedAlthough 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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2016
Date type not reportedThis date has not been verified as actual or estimated.
October 31, 2016
Actual (reported)November 2, 2016
Actual (reported)February 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
[18F]FEOBV binding
the difference in VAChT brain binding on a \[18F\]FEOBV PET-scan between PD patients and healthy control subjects.
baseline
Test-retest reliability
one week
Neuropsychological performance
baseline
patients with Parkinson's disease, between the ages of 45 and 65, with a disease duration of 3 - 10 years
Healthy control subjects, between the ages of 45 and 65
Cholinergic PET scan with the tracer \[18F\]Fluoroethoxybenzovesamicol
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
University Medical Center Groningen
Groningen, Provincie Groningen, 9713 RB, Netherlands
Teus van Laar, Prof. Dr.
University Medical Center Groningen
First Submitted
October 31, 2016
First Posted
November 2, 2016
Study Start
September 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2017
The Personalized Parkinson Project (PPP)
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 29, 2016
Record last verified: 2016-11
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Source: ClinicalTrials.gov.
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