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Neurodegenerative Diseases Registry (NDD Registry)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04472130
Recruitment Status : Recruiting
First Posted : July 15, 2020
Last Update Posted : July 15, 2020
Information provided by (Responsible Party):
Vincent Mok, Chinese University of Hong Kong

Brief 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.

Condition or disease
Neurodegenerative Diseases Parkinson Disease Multiple System Atrophy Progressive Supranuclear Palsy

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.

  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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years
Official Title: Biomarkers in Neurodegenerative Diseases
Actual Study Start Date : October 9, 2019
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024

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

Primary Outcome Measures :
  1. the score change in Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: baseline visit, 2 years after baseline visit, 4 years after baseline visit ]
    The Unified Parkinson's Disease Rating Scale (UPDRS) would be administered to assess disease severity for iPD, PSP and SVD patients with parkinsonism features

  2. the score change in Unified MSA Rating Scale (UMSARS) [ Time Frame: baseline visit, 2 years after baseline visit, 4 years after baseline visit ]
    The Unified MSA Rating Scale (UMSARS) would be administered to assess disease severity for patients with MSA

  3. the score change in Montreal Cognitive Assessment Hong Kong version (HK-MoCA) [ Time Frame: baseline visit, 2 years after baseline visit, 4 years after baseline visit ]
    Montreal Cognitive Assessment Hong Kong version (HK-MoCA) is used to assess participants' cognitive functions for all groups

Biospecimen Retention:   Samples With DNA
Plasma, blood cells, cerebrospinal fluid

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04472130

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Contact: Elyia Han, Bachelor +852 2697 5027
Contact: Pauline Kwan, Master +852 2635 2160

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Hong Kong
Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Elyia Han, Bachelor    +852 26975027   
Sponsors and Collaborators
Vincent Mok
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Principal Investigator: Vincent Mok, PhD Chinese University of Hong Kong
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Responsible Party: Vincent Mok, Professor, Chinese University of Hong Kong Identifier: NCT04472130    
Other Study ID Numbers: CRE-2019.371
First Posted: July 15, 2020    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vincent Mok, Chinese University of Hong Kong:
Neurodegenerative Diseases
Parkinson Disease
Additional relevant MeSH terms:
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Parkinson Disease
Neurodegenerative Diseases
Multiple System Atrophy
Shy-Drager Syndrome
Supranuclear Palsy, Progressive
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ocular Motility Disorders
Cranial Nerve Diseases
Neurologic Manifestations
Eye Diseases
Signs and Symptoms