NCT03592563

Brief Summary

The goal of this study is to develop a large longitudinal cohort of individuals diagnosed with or at high risk for brain diseases (both neurological and psychiatric in nature), in order to identify risk factors that contribute to neurological and psychiatric diseases over time. The investigators seek to capture relevant information from medical records, electronically administered questionnaires and follow up phone-based interviews. The investigators expect to eventually have sufficient power from our dataset to examine risk factors for a variety of brain disorders, both individually and in aggregate. Our ultimate goal is to offer scientifically validated ways to preserve and promote brain health by working with our patients' needs and tracking their progress over time.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
274mo left

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress24%
Jul 2019Dec 2048

First Submitted

Initial submission to the registry

June 13, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
12 months until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
19.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2038

Expected
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2048

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

19.5 years

First QC Date

June 13, 2018

Last Update Submit

February 21, 2026

Conditions

Keywords

strokedementiaAlzheimer diseaseHealth BrainHealth knowledge

Outcome Measures

Primary Outcomes (1)

  • Risk factors contributing to neurological and psychiatric diseases

    The participants' electronic medical records and questionnaires done (either symptomatic or asymptomatic) would be compared with their follow-up electronic medical records/phone follow-up interview and questionnaires done over time.

    December, 2038

Study Arms (3)

Red group

Those participants who had established diagnosis of one or more neurological and/or psychiatric conditions Baseline: The participants' medical history, signs, symptoms and diagnoses of neurological and/or psychiatric disorders would be recorded. Neuro-QoL questionnaire plus an additional subset of questions based on their clinical diagnosis should be done.

Behavioral: Neuro-QoL questionnaire

Yellow group

Those participants who are high-risk to develop one or more neurological and/or psychiatric conditions, for example: 1. family history (first degree relative) one or more neurological and/or psychiatric conditions; 2. examination, imaging or laboratory findings consistent with pre-symptomatic stages of one or more neurological and/or psychiatric disorders. Baseline: The participants' medical history, signs, symptoms and diagnoses of neurological and/or psychiatric disorders would be recorded. Neuro-QoL questionnaire should be done.

Behavioral: Neuro-QoL questionnaire

Green group

Those participants who are not meeting criteria for Red or Yellow groups, but interested in longitudinal research on maintenance and/or improvement of their brain health. Baseline: The participants' medical history would be recorded and Neuro-QoL questionnaire should be done.

Behavioral: Neuro-QoL questionnaire

Interventions

Follow-up over time will continue (either in-person or over the phone) using the same questionnaires (depending on which group they are belongs to) at approximately 6-month intervals. During each follow-up, participants will be screened for any new signs, symptoms and diagnoses of neurological and/or psychiatric disorders, in order to correlate these outcomes with risk factors captured using the procedures described above.

Green groupRed groupYellow group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. Chinese ONLY 2. Hong Kong Resident

You may qualify if:

  • Adult ≥ 18 years of age
  • Fulfilling criteria for membership in one of these three groups:
  • Red group: established diagnosis of one or more neurological and/or psychiatric conditions
  • Yellow group: high-risk to develop one or more neurological and/or psychiatric conditions
  • family history (first degree relative) one or more neurological and/or psychiatric conditions
  • examination, imaging or laboratory findings consistent with pre-symptomatic stages of one or more neurological and/or psychiatric disorders
  • Green group: not meeting criteria for Red or Yellow groups, but interested in longitudinal research on maintenance and/or improvement of brain health
  • Subject provides informed consent by signing and dating the written informed consent form
  • Subject is willing to answer health questionnaires and be followed longitudinally

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

30ml of EDTA blood will be collected for genome sequencing or PCR gene expression. 5-10ml of stool will be collected for microbiome study.

MeSH Terms

Conditions

Ischemic StrokeStrokeDementiaBrain IschemiaBrain DiseasesAlzheimer DiseaseBehavior

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative Diseases

Study Officials

  • Thomas Wai Hong LEUNG, FRCP

    Division of Neurology, The Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Wai Hong LEUNG, FRCP

CONTACT

Tiffany Chung, M.Phil

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 13, 2018

First Posted

July 19, 2018

Study Start

July 1, 2019

Primary Completion (Estimated)

December 31, 2038

Study Completion (Estimated)

December 31, 2048

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

De-identified data and health information may be sent out to our research collaborators at Massachusetts General Hospital and Harvard Medical School, where there is a sister institute for brain health for additional analysis.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
The de-identified health information and data would be stored for more than 10 years, so that we can offer scientifically validated ways to preserve and promote brain health by working with our patients' needs and tracking their progress over time. This is because individuals diagnosed with neurological and psychiatric disorders can experience the very first symptoms up to 10-20 years before diagnosis.
Access Criteria
These de-identified data will be stored by collaborating institutions in a manner consistent with data storing secure procedures. Only principle investigator, study coordinator and related staffs can access.

Locations