The main objective of this study is to predict the rate of decline for both motor and cognitive function in an existing PD patient cohort using a combination of baseline CSF and blood biomarker profiles (T0). The secondary objective is to determine…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* UPDRS III score (T1-T0)
* MMSE score (T1-T0)
Secondary outcome
* 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
Background summary
Parkinson*s disease (PD) is a neurodegenerative disorder characterized by
progressive decline involving a broad range of functional domains. There is
considerable variability in the rate of progression of motor manifestations and
in the prevalence of non-motor manifestations. Unfortunately, prediction of the
differences in clinical expression is difficult and currently there is no
effective biomarker to robustly predict or monitor disease progression in PD.
Study objective
The main objective of this study is to predict the rate of decline for both
motor and cognitive function in an existing PD patient cohort using a
combination of baseline CSF and blood biomarker profiles (T0). The secondary
objective is to determine whether changes in the level of CSF and/or
blood-based biomarkers over time correlate with clinical measures of motor
progression, cognitive decline, neuropsychiatric symptoms and Activities of
Daily Living (ADL) functions (T1 versus T0).
Study design
longitudinal cohort study
Study burden and risks
For patients still under treatment in the VU university medical centre, study
procedures will be combined with a regular visit to the outpatient clinic for
movement disorders. For patients under treatment in other clinics, study
procedures will be performed during a single visit to the outpatient clinic.
Clinical examination, cognitive testing and filling out questionnaires will
take approximately four hours, depending on the functional state of the
participating patients, including 60 minutes for breaks. Lumbar puncture and
venous blood puncture will take approximately 30 minutes; a total amount of 12
ml CSF and 25 ml blood will be obtained from each patient. Risks associated
with a venous blood puncture include a local haematoma and, rarely, an
infection. Risks associated with a lumbar puncture include post lumbar puncture
headache, infection (arachnoiditis, meningitis or abscess) and haemorrhage.
These risks will be minimized by the applied puncture procedures and
experienced physicians/nurses. As the main objective of this project is
prediction of the rate of cognitive decline, it is inevitable that some
patients will have developed cognitive impairment at follow-up (8-9 years after
baseline) and/or are diagnosed with dementia. Therefore, this study cannot be
conducted without the participation of subjects suffering from cognitive
deficits.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
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
* 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL60345.029.17 |