Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2017-10-01
2023-10-01
Brief Summary
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Detailed Description
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Parkinson's disease (PD) is characterized by both motor and non-motor symptoms, including cognitive decline. Mild cognitive impairment (PD-MCI) is already present at time of diagnosis in 24-36% of PD patients. Cognitive impairment in PD is associated with both cholinergic and dopaminergic deficiencies in the brain. Although dopaminergic neuronal degeneration is quite well established in relationship to the motor impairment, the rate and extent of the cholinergic neuronal degeneration in the course of PD is unknown. It is also unclear how cholinergic and dopaminergic degeneration contributes to cognitive deficits found in early and more advanced PD and its role in the progression over time.
Objectives:
The primary objective is to establish the relationship between cognitive impairment and cholinergic neurodegeneration in de novo PD patients, by studying cholinergic imaging using \[ 18 F\]Fluoroethoxy-Benzovesamicol (\[18F\]FEOBV) positron emission tomography (PET) and neuropsychological performance over time.
Secondary objectives include: (1) the investigation of possible predictive factors using optical coherence tomography and (2) to determine the relative contributions of PD diagnosis and dopaminergic medication use to the changes in microbiota composition observed in PD patients.
Study design:
At baseline patients will undergo the following investigations and questionnaires: Demographics, detailed medical history, neuropsychological assessment, imaging including MRI brain, dopaminergic Fluoro-18-L-Dihydroxyphenylalanine (18F-FDOPA) and cholinergic FEOBV PET, optical coherence tomography (OCT) and microbiota composition. At one year follow-up subjects will undergo motor-, neuropsychological, and microbiota assessment. At 3 year follow up baseline measurements will be repeated in its entirety with the exception of the genetic and gastrointestinal assessments.
Study population:
150 de novo PD patients, recruited from the neurological practices in the northern area of the Netherlands and healthy control subjects. Healthy age-,sex- and constipation-matched controls will be assessed on microbiota composition
Assessment and endpoints related to gastroenterological assessment have been approved under a separate research protocol (NL61123.042.17 - CCMO) and has been officially linked to the overall protocol.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Parkinson's disease patients
150 de novo treatment naive Parkinson's disease patients.
No interventions assigned to this group
Healthy control subjects
150 Healthy sex- and age-matched controls, also matched according to presence and severity of constipation, serving as a control group for microbiome composition analyses.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Dopaminergic medication use.
Exclusion from PET imaging:
* Pregnant women
* Breast feeding women
Exclusion from MRI:
* MRI incompatible implants in the body (e.g. prosthesis, pacemakers, implanted heart valves)
* Any risk of having metal particles in the eyes due to manual work without proper eye protections
* Tattoos containing red pigments that form a safety risk.
Exclusion from gastrointestinal assessment:
* Active or persistent primary disease of the gastrointestinal tract
* History of peritonitis, severe endometriosis, abdominal, intestinal or urogenital fistula,
* Hepatobiliary or pancreatic disease (except asymptomatic cholecystolithiasis)
* History of abdominal or anorectal surgery, except minor surgery such as uncomplicated appendectomy or cholecystectomy (\>6 months ago).
* Severe gynaecological prolapse (grade III)
* Cancer and/or adjuvant treatment within the last 6 months
* Within the last three months: severe hypo- or hyperkalemia, narcosis, analgosedation, endoscopic procedure of the gastrointestinal tract, abdominal trauma
* Within the last three months: gastrointestinal tract infection, food intoxication
18 Years
ALL
Yes
Sponsors
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Parkinson Platform Noord Nederland
UNKNOWN
University Medical Center Groningen
OTHER
Responsible Party
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Teus van Laar
Professor of Neurology
Principal Investigators
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Teus van Laar, MD PhD
Role: STUDY_CHAIR
University Medical Center Groningen
Locations
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University Medical Center Groningen
Groningen, , Netherlands
Countries
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Central Contacts
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References
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Chrysou A, Heikka T, van der Zee S, Boertien JM, Jansonius NM, van Laar T. Reduced Thickness of the Retina in de novo Parkinson's Disease Shows A Distinct Pattern, Different from Glaucoma. J Parkinsons Dis. 2024;14(3):507-519. doi: 10.3233/JPD-223481.
Boertien JM, van der Zee S, Chrysou A, Gerritsen MJJ, Jansonius NM, Spikman JM, van Laar T; PPNN Study Group. Study protocol of the DUtch PARkinson Cohort (DUPARC): a prospective, observational study of de novo Parkinson's disease patients for the identification and validation of biomarkers for Parkinson's disease subtypes, progression and pathophysiology. BMC Neurol. 2020 Jun 13;20(1):245. doi: 10.1186/s12883-020-01811-3.
Other Identifiers
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NL60540.042.17
Identifier Type: REGISTRY
Identifier Source: secondary_id
201700171
Identifier Type: -
Identifier Source: org_study_id