The Dutch Parkinson and Cognition Study
NCT04180865, Unknown, University Medical Center Groningen
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | The Dutch Parkinson and Cognition Study | ClinicalTrials.gov |
| NCT number | NCT04180865 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Enrollment | 150 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University Medical Center Groningen | ClinicalTrials.gov |
| Conditions | Parkinson Disease | ClinicalTrials.gov |
| First posted | 2019-11-29 | ClinicalTrials.gov |
| Last updated | 2019-11-29 | ClinicalTrials.gov |
Registered outcomes 34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | [18F]FEOBV PET | Baseline | Cortical and subcortical cholinergic innervation as measured by \[18F\] FEOBV PET imaging | ClinicalTrials.gov |
| Secondary | Cognitive screening | baseline | General cognitive performance will be assessed using a cognitive screening; the Montreal Cognitive Assessment (MOCA). The MOCA test covers the important cognitive domains including memory, attention, executive function, language and visuospatial abilities, resulting in one total score of cognitive performance. MOCA score ranges between 0 and 30, with higher scores representing better performance. | ClinicalTrials.gov |
| Secondary | Memory performance | baseline | Memory performance will be calculated as an average Z-score of two cognitive tests; the Rey auditory verbal learning test for measuring verbal memory and the location learning test for measuring visual memory. Based on established normative data, a z-score for each test outcome will be calculated, representing performance compared to an age-, gender- and educational level-matched control group. A Z-score of 0 (zero) represents a performance similar to the normative data. A positive z-score represents better performance, while a negative z-score represents worse performance. There is no minimum or maximum z-score. These z-scores from both tests will be averages to form one outcome measurement representing memory performance. | ClinicalTrials.gov |
| Secondary | Attention and working memory performance | baseline | Attention performance will be calculated as an average Z-score of three cognitive tests; the Stroop color-word test, the digit span and the Vienna test system reaction time measurement. Based on established normative data, a z-score for each test outcome will be calculated, representing performance compared to an age-, gender- and educational level-matched control group. A Z-score of 0 (zero) represents a performance similar to the normative data. A positive z-score represents better performance, while a negative z-score represents worse performance. There is no minimum or maximum z-score. These z-scores from all three tests will be averages to form one outcome measurement representing attention performance. | ClinicalTrials.gov |
| Secondary | Executive function performance | baseline | Executive function performance will be calculated as an average Z-score of four cognitive tests; the trail making test, the Wisconsin card sorting test, the Hayling Sentence completion test and the letter fluency test. Based on established normative data, a z-score for each test outcome will be calculated, representing performance compared to an age-, gender- and educational level-matched control group. A Z-score of 0 (zero) represents a performance similar to the normative data. A positive z-score represents better performance, while a negative z-score represents worse performance. There is no minimum or maximum z-score. These z-scores from all tests will be averages to form one outcome measurement representing executive performance. | ClinicalTrials.gov |
| Secondary | Visouspatial abilities | baseline | Cognitive visuospatial abilities will be calculated as an average Z-score of two cognitive tests; the Judgement of line orientation and the Map search subtest of the test of everyday attention. Based on established normative data, a z-score for each test outcome will be calculated, representing performance compared to an age-, gender- and educational level-matched control group. A Z-score of 0 (zero) represents a performance similar to the normative data. A positive z-score represents better performance, while a negative z-score represents worse performance. There is no minimum or maximum z-score. These z-scores from all tests will be averages to form one outcome measurement representing visuospatial abilities. | ClinicalTrials.gov |
| Secondary | Language performance | baseline | Language performance will be calculated as an average Z-score of two cognitive tests; the Boston Naming test and the verbal fluency test. Based on established normative data, a z-score for each test outcome will be calculated, representing performance compared to an age-, gender- and educational level-matched control group. A Z-score of 0 (zero) represents a performance similar to the normative data. A positive z-score represents better performance, while a negative z-score represents worse performance. There is no minimum or maximum z-score. These z-scores from all tests will be averages to form one outcome measurement representing language performance. | ClinicalTrials.gov |
| Secondary | Social cognition | baseline | Social cognition abilities will be represented as a z-score calculated from the performance on the FEEST; Facial Expression of Emotion Stimuli and tests. Based on established normative data, a z-score of the test outcome will be calculated, representing performance compared to an age-, gender- and educational level-matched control group. A Z-score of 0 (zero) represents a performance similar to the normative data. A positive z-score represents better performance, while a negative z-score represents worse performance. There is no minimum or maximum z-score. These z-scores from the FEEST test represents social cognition performance. | ClinicalTrials.gov |
| Secondary | Brain grey matter volume | Baseline, 3 year follow-up | Grey matter volume as measured by structural MRI. | ClinicalTrials.gov |
| Secondary | resting state functional MRI | Baseline, 3 year follow-up | resting state functional MRI | ClinicalTrials.gov |
| Secondary | MRI: Arterial spin labeling | Baseline, 3 year follow-up | cerebral blood perfusion as measured by arterial spin labeling MRI | ClinicalTrials.gov |
| Secondary | MRI: Diffusion weighted image | Baseline, 3 year follow-up | White matter assessment as measured by diffusion weighted image | ClinicalTrials.gov |
| Secondary | MRI: susceptibility weighted image | Baseline, 3 year follow-up | Brain hemorrhage and iron storage as measured by susceptibility weighted image | ClinicalTrials.gov |
| Secondary | Optical Coherence tomography | Baseline and 3 year follow-up | Imaging of the retinal cell layers | ClinicalTrials.gov |
| Secondary | fecal zonulin | baseline | fecal zonulin as one of the measures of intestinal wall permeability | ClinicalTrials.gov |
| Secondary | Microbiota composition | Baseline and 1 year follow-up | Taxonomic classification of gut microbiota composition based on 16s ribosomal RNA-gene sequencing. | ClinicalTrials.gov |
| Secondary | fecal alpha1-antitrypsin | baseline | fecal alpha1-antitrypsin as one of the measures of intestinal wall permeability | ClinicalTrials.gov |
| Secondary | serum zonulin | baseline | serum zonulin as one of the measures of intestinal wall permeability | ClinicalTrials.gov |
| Secondary | serum lipopolysaccharide binding protein | baseline | serum lipopolysaccharide binding protein as one of the measures of intestinal wall permeability | ClinicalTrials.gov |
| Secondary | multi-sugar urinary excretion test | baseline | multi-sugar urinary excretion test as one of the measures of intestinal wall permeability | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 2
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 9
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Card Sorting Test (Berg) | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Picture Naming Test | Secondary outcome | ConductCognition |
| Sentence Completion Inhibition Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)