Overall aim: To examine the association between olfactory function, motor, and non-motor symptoms in a longitudinal cohort of PD patients.Specific objective(s): 1. To determine whether the degree of hyposmia in PD is associated with disease duration…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Olfactory function, measured with University of Pennsylvania Smell
Identification Test (UPSIT)
Secondary outcome
-disease duration (years)
-Unified Parkinson's disease Rating Scale - motor score (UPDRS III)
-Mini-Mental State Exam (MMSE)
-Montreal cognitive assessment (MoCA)
-scales for outcomes of Parkinson's disease (SCOPA)-Sleep
-SCOPA-autonomic dysfunction
-SCOPA-psychiatric complications
-Beck Depression Inventory (BDI)
-Beck Anxiety Inventory (BAI)
-Cognitive tests: Digit Span, Stroop Color-Word test, Letter fluency, Category
fluency, Rey's auditory Verbal Learning Test, clock drawing
-Modified Hoehn & Yahr stage
-Body Mass index (length/weight)
-Blood pressure (lying down, 1 min standing, 3 min standing)
-Medication Use (levodopa equivalent dose)
Background summary
Parkinson*s disease (PD) is a neurodegenerative disorder characterized by a
combination of motor and non-motor symptoms (i.e. hyposmia, psychiatric
symptoms, cognitive decline, sleeping disorders and autonomic dysfunction). It
is a highly heterogeneous disorder, in which the individual disease course is
variable and cannot be predicted. Hyposmia (olfactory loss) is highly prevalent
(up to 90%) and may precede the first motor symptoms for 5-10 years. In an
earlier cross-sectional study (Roos et al, 2019), we observed a correlation
between the degree of hyposmia and various motor and non-motor symptoms as well
as a marker of presynaptic dopamine neuronal function as assessed with dopamine
transporter single-photon emission computed tomography (DaT-SPECT). It is
unclear, however, to what extent hyposmia is longitudinally related to the
other PD-related (non-) motor symptoms and may be useful as a marker of disease
progression.
Study objective
Overall aim:
To examine the association between olfactory function, motor, and non-motor
symptoms in a longitudinal cohort of PD patients.
Specific objective(s):
1. To determine whether the degree of hyposmia in PD is associated with disease
duration.
2. To determine whether olfactory function is related to other (non-)motor
symptoms in PD patients.
3. To examine whether or not baseline hyposmia predicts more rapid disease
progression in PD.
Study design
Longitudinal observational study.
Study burden and risks
The risks associated with participation are negligible. For patients still
under treatment at Amsterdam UMC, location VUmc, the study visit will be
combined with a regular visit to the outpatient clinic for movement disorders,
or a home visit. For patients not under treatment at Amsterdam UMC, location
VUmc, the study procedure will be performed during a single visit to the
hospital or a home visit. The full assessment, including clinical neurological
exam (focussing on parkinsonism), evaluation of olfactory function, various
scales and questionnaires, and cognitive testing will take approximately three
hours.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
*Included in the baseline cohort with a diagnosis of Parkinson's disease
according to the UK PD Society Brain Bank criteria
*Be able to understand the aim of the current follow-up study, understand the
study procedure and be able to give written informed consent
Exclusion criteria
*Diagnosis changed from PD to another form of parkinsonism
*Unwillingness to be informed of unexpected medical findings
*Lack of mastery of Dutch language
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 | NL71019.029.19 |