Linking protein profiles to disease progression and clinical expression in Parkinson*s disease: part two, longitudinal outcomes

Linking protein profiles to disease progression and clinical expression in Parkinson*s disease: part two, longitudinal outcomes - PROGRESS-PD

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47594

Enrollment

Registered

2018-04-30

Start date

2018-01-10

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Parkinson's disease

Interventions

biochemical biomarkers

cognitive decline

motor progression

Parkinson's disease

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: * Patients from the baseline cohort diagnosed with Parkinson*s disease according to the MDS Clinical Diagnostic Criteria for Parkinson*s Disease * Mini-Mental State Examination (MMSE) score *18 at recruitment * Being able to understand the aim of the study and the study procedure and give written informed consent

Exclusion criteria

Exclusion criteria: * A history of neurological disorders other than PD, that affect the central nervous system or are known to influence CSF proteins * Unwillingness to be informed of unexpected medical findings;Potential subjects are eligible to participate in this study if they cannot undergo lumbar puncture due to the following reasons: * No CSF collected at baseline * Use of anticoagulants or a history of coagulation disorders * Infected skin over the needle entry site for lumbar puncture * Signs of raised intracranial pressure * Travelling to the VUmc outpatient clinic is too burdensome * Unwillingness to undergo lumbar puncture These subjects we will undergo all study procedures with the exception of CSF collection.

Design outcomes

Primary

Measure	Time frame
* UPDRS III score (T1-T0) * MMSE score (T1-T0)	—

Secondary

Measure	Time frame
* Hoehn and Yahr stage (T1) * Test scores representing the five most affected cognitive domains in PD (attention, executive function, memory, visuospatial function and language) (T1) * Presence of PD mild cognitive impairment (PD-MCI) and PD dementia (PD-D) according to the MDS diagnostic criteria (T1) * Activity of Daily Living (T1): UPDRS part II, Schwab and England ADL scale * CSF and blood-based biomarker concentration (T1) * Predefined genetic factors associated with cognitive decline in PD * Test scores for neuropsychiatric symptoms in PD (T1): SCOPA Psychiatrische Complicaties (SCOPA-PC), Beck Depression Inventory, Beck Anxiety Inventory	—

Measure

Time frame

* Hoehn and Yahr stage (T1) * Test scores representing the five most affected cognitive domains in PD (attention, executive function, memory, visuospatial function and language) (T1) * Presence of PD mild cognitive impairment (PD-MCI) and PD dementia (PD-D) according to the MDS diagnostic criteria (T1) * Activity of Daily Living (T1): UPDRS part II, Schwab and England ADL scale * CSF and blood-based biomarker concentration (T1) * Predefined genetic factors associated with cognitive decline in PD * Test scores for neuropsychiatric symptoms in PD (T1): SCOPA Psychiatrische Complicaties (SCOPA-PC), Beck Depression Inventory, Beck Anxiety Inventory

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)