Neurodegenerative DiseasesNDD RegistryNCT04472130
Neurodegenerative Diseases Registry
An observational study of Neurodegenerative Diseases and Parkinson Disease, run by Vincent Mok at 1 site in Hong Kong.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurodegenerative Diseases, Parkinson Disease, Multiple System Atrophy
- How many people
- 1,400 participants
- Where
- 1 siteHong Kong
- Study dates
- 9 Oct 2019to 1 Aug 2031
- How long will I take part?
- 4 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be recruited in neurology outpatient clinic in Prince of Wales Hospital, Hong Kong, who meet the inclusion and exclusion criteria listed above.
Who may be able to join
- Age should be between 18-80 years old.
Who cannot join
- Patients with ongoing central nervous system infection and/or acute stroke or active brain tumor.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Chinese University of Hong Kong
Hong Kong
Elyia Han, Bachelor, +852 26975027, elyiahan@cuhk.edu.hk
About this study
Official title: Biomarkers in Neurodegenerative Diseases
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.
Read the detailed 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.
- 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.
- 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.
- 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.
- Conditions
- Neurodegenerative Diseases, Parkinson Disease, Multiple System Atrophy, Progressive Supranuclear Palsy
- Keywords
- Neurodegenerative Diseases, Parkinson Disease
- Medical subject headings
- Neurodegenerative Diseases, Parkinson Disease, Multiple System Atrophy, Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Early idiopathic Parkinson's Disease | 200 patients with iPD based on Movement Disorder Society clinical diagnostic criteria for Parkinson's disease with disease onset less than 5 years | |
| Non-early idiopathic Parkinson's Disease | 200 patients with iPD based on Movement Disorder Society clinical diagnostic criteria for Parkinson's disease with disease onset more than 5 years | |
| Multiple System Atrophy | 100 patients with Multiple System Atrophy based on Second consensus statement on the diagnosis of MSA | |
| Progressive Supranuclear Palsy | 100 patients with Progressive Supranuclear Palsy based on Clinical research criteria for diagnosis of PSP | |
| Alzheimer's Disease | 100 patients with Alzheimer's Disease by Diagnostic and Statistical Manual of Mental disorder, Fifth edition (DSM-5) criteria | |
| Motor Neuron Disease | 200 patients with Motor Neuron Diseases by revised El Escorial criteria or Awaji ALS criteria | |
| Small Vessel Disease | 200 patients with cerebral Small Vessel Diseases | |
| Frontotemporal Dementia | 100 patients with Frontotemporal Dementia by International consensus criteria for behavioral variant FTD (FTDC) or Primary Progressive Aphasia by Gorno-Tempini | |
| Healthy Control | 200 age and sex matched healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
the score change in Unified Parkinson's Disease Rating Scale (UPDRS)
The Unified Parkinson's Disease Rating Scale (UPDRS) would be administered to assess disease severity for iPD, PSP and SVD patients with parkinsonism features
Measured: baseline visit, 2 years after baseline visit, 4 years after baseline visit
the score change in Unified MSA Rating Scale (UMSARS)
The Unified MSA Rating Scale (UMSARS) would be administered to assess disease severity for patients with MSA
Measured: baseline visit, 2 years after baseline visit, 4 years after baseline visit
the score change in Montreal Cognitive Assessment Hong Kong version (HK-MoCA)
Montreal Cognitive Assessment Hong Kong version (HK-MoCA) is used to assess participants' cognitive functions for all groups
Measured: baseline visit, 2 years after baseline visit, 4 years after baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start9 Oct 2019
- Primary completion1 Aug 2031 (estimated)
- Study completion1 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodegenerative DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,400 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Vincent Mok
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vincent Mok, Chinese University of Hong Kong
- Investigators
- Vincent Mok, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472130
- Sponsor's protocol ID
- CRE-2019.371
- Acronym
- NDD Registry
- Status last verified
- Sep 2026
- First submitted
- 25 Jun 2020
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No