ClinicalTrials.gov record NCT04472130
Neurodegenerative Diseases Registry
Biomarkers in Neurodegenerative Diseases
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This prospective registry collects clinical assessments, questionnaires and blood samples from people with several neurodegenerative diseases and from healthy controls. Participants have a baseline visit and are followed with similar assessments about every 1–2 years for up to 4 years. Selected participants may be offered optional sub-studies such as brain MRI, PET, lumbar puncture, or skin biopsy.
What it is studying. The study aims to build a large database of clinical, cognitive, behavioral, lifestyle and blood-based biomarker and genetic information across multiple neurodegenerative conditions and healthy controls, and to track how symptoms and measurements change over time.
What the researchers hope to learn. To generate data and samples that can help identify diagnostic biomarkers, clarify genetic and molecular contributors to neurodegenerative diseases, describe symptom development over time, and support more accurate diagnostic tests and future clinical research.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Age should be between 18-80 years old.
Exclusion criteria
- Patients with ongoing central nervous system infection and/or acute stroke or active brain tumor.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants attend a baseline visit and then follow-up visits every 1–2 years over a total of about 4 years, repeating the same assessments and questionnaires. Visits include clinical rating scales and questionnaires about symptoms, cognition, sleep, mood and daily function; some groups receive additional disease‑specific scales. Video recordings of eye movements may be taken when needed. Blood samples are collected (total blood volume will not exceed 23 ml) for laboratory and genetic studies, and selected participants may be invited, voluntarily, to sub-studies such as brain MRI, brain PET, lumbar puncture, and/or skin biopsy.
How the study is structured. A prospective observational cohort (registry) with a baseline visit and scheduled follow-ups roughly every 1–2 years over a 4-year period. Participants are enrolled into disease-specific groups and an age- and sex-matched healthy control group. At each visit participants complete clinical assessments and questionnaires; blood samples are taken and stored for biomarker and genetic analyses. Some participants may voluntarily join optional sub-studies (brain MRI, brain PET, lumbar puncture, skin biopsy) and video recordings of eye movements may be done when relevant.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in Hong Kong. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on multiple system atrophy
This trial is also listed on this site under progressive supranuclear palsy.
Important dates
- Study start
- Oct 9, 2019
- Primary completion
- Aug 1, 2031 (estimated)
- Study completion
- Aug 1, 2031 (estimated)
- Target enrollment
- 1400 participants (estimated)
- Last updated on registry
- Sep 18, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Vincent Mok
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Elyia Han, Bachelor 📞 +852 2697 5027 ✉ elyiahan@cuhk.edu.hk
- Pauline Kwan, Master 📞 +852 2635 2160 ✉ paulinekwan@cuhk.edu.hk
Participating sites (1)
- Chinese University of Hong KongRecruiting
Hong Kong · Hong Kong
- Elyia Han, Bachelor · +852 26975027 · elyiahan@cuhk.edu.hk
Terms used on this page · explanations by MedicalUpdates.ai
- life expectancy
- Some studies require that, in the investigator's judgement, a participant is likely to live long enough to complete the study period. It is a study requirement, not a prediction about any individual.
- registry
- An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- cohort study
- A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
- baseline
- Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
- follow up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- forced vital capacity
- A breathing test that measures the total amount of air a person can blow out after a full breath in. It is often given as a percentage of what is expected for a person's age and size.
- MRI
- A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
- PET
- A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
- lumbar puncture
- A procedure in which a needle is placed between the bones of the lower back to collect spinal fluid or to give a treatment.
- biopsy
- Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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