Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04472130 |
| Other study ID # |
CRE-2019.371 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 9, 2019 |
| Est. completion date |
August 2024 |
Study information
| Verified date |
July 2021 |
| Source |
Chinese University of Hong Kong |
| Contact |
Elyia Han, Bachelor |
| Phone |
+852 2697 5027 |
| Email |
elyiahan[@]cuhk.edu.hk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
With the increase in life expectancy of our population due to advancement of medical
diagnosis and treatments, the incidence of age dependent neurodegenerative diseases
increased, including Alzheimer's disease (AD), parkinsonian syndromes (PS), small vessel
disease (SVD) and motor neuron disease (MND). In spite of the progress of knowing the
pathogenesis of various neurodegenerative diseases at molecular and genetic level, they are
still very incompletely understood and often cause diagnostic and therapeutic challenges to
physicians. Due to the overlapping presentation and similar brain pathology, especially in
the early stage of the diseases, it is difficult to differentiate idiopathic Parkinson's
disease (iPD) from atypical parkinsonian syndromes, such as multiple system atrophy (MSA) and
progressive supranuclear palsy (PSP). Similarly, distinguishing AD from other dementia
syndromes including frontotemporal dementia (FTD), dementia with Lewy Bodies (DLB),
corticobasal degeneration (CBD) and vascular dementia can be difficult. It is necessary to
develop accurate and comprehensive diagnostic tests to properly prognosticate the diseases,
start treatments in early stage of the diseases and maximize the accuracy of drug trials for
more effective preventive and therapeutic measures for these neurodegenerative diseases.
Therefore, the registry aims to generate a large database of cognitive, behavioral, lifestyle
and psychological information of the subjects who suffered from neurodegenerative diseases,
as well as to examine the genetic basis of neurodegenerative diseases to help decode the
pathogenic mechanisms of the diseases. The registry may provide important information to
understand symptom development of the neurodegenerative diseases, in which may help
physicians to diagnose the diseases more accurately and provide better treatment plans.
Description:
This is a cohort study. It involves baseline, 1st follow up visit and 2nd follow up visit. At
baseline visit, all participants will go through a list of assessments and questionnaires and
blood taking. Follow-up visit(s) will be scheduled every one to two years, in which the same
set of assessments and questionnaires will be administered.
1. Clinical assessments and questionnaires
Different clinical assessments would be administered depending on the group that the
participant belongs to:
- Hoehn and Yahr Stage and the Unified Parkinson's Disease Rating Scale (UPDRS) for
iPD, PSP and SVD patients with parkinsonism features
- Unified MSA Rating Scale (UMSARS) for MSA
- Levodopa Equivalent Dosage for medication burden for parkinsonian syndromes
patients
- Amyotrophic lateral sclerosis functional rating scale revised (ALSFRS-R), body
weight and forced vital capacity (FVC) for MND group
- Montreal Cognitive Assessment Hong Kong version (HK-MoCA), Olfactory Identification
Test (OIT) and Farnsworth-Munsell 100 Hue test for all groups
Video taking would be administered to record participants' eye movement if necessary.
For example, video of eye movement is useful to rate MSA patients' ocular motor
dysfunction, such as gaze-evoke nystagmus.
Patients with parkinsonian syndromes will fill in a set of questionnaires, including
demographic information, medical history, history and current medications, wearing-off
questionnaire, impulsiveness questionnaire, Buss-Perry Aggression Questionnaire (BPAQ),
rapid eye movement sleep behavior disorder questionnaire (RBDQ), Epworth Sleepiness
Scale (ESS), Morningness-Eveningness Questionnaire (MEQ), Insomnia Severity Index (ISI),
Beck's Scale for Suicide Ideation (BSSI), Scales for Outcomes in Parkinson's
Disease-Autonomic questionnaire (SCOPA-AUT), Hospital Anxiety and Depression Scale
(HADS), Patient Health Questionnaire (PHQ9), lifestyle and life history, and occupation
history.
2. Blood sampling Blood taking would be carried out at Prince of Wales Hospital and will be
processed and transported to the laboratory according to standard procedure.
Venous blood samples are collected into 6 EDTA tubes and 1 Heparin tube. The volume of
total blood samples will not exceed 23ml. Serum is obtained within 1 hour by
centrifugation at 3,000 rpm for 10 min and stored at -70°C until laboratory evaluation
for proteomics, SERS and other biochemical and genetics studies.
3. Sub-studies Selected participants in the cohort groups, especially those with early
disease onset and/or familial cases, would proceed to sub-studies which include brain
MRI, brain PET, lumbar puncture and/or skin biopsy. Subjects are voluntary to join one
or more sub-studies.
