Epigenetic Biomarkers for Alzheimer's Disease | NCT04081285

Studies
Epigenetic Biomarkers for Alzheimer's Disease

NCT04081285

Sponsor

Chinese University of Hong Kong

Status

Completed

Last Update Posted

Apr 29, 2025Actual

Enrollment

250Actual

Phase

Not provided

Conditions

Alzheimer Disease

Interventions

Not provided

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2019Actual

Primary Completion Date

Nov 30, 2024Actual

Completion Date

Nov 30, 2024Actual

First Submitted Date

Jul 23, 2019

First Submission Date that Met QC Criteria

Sep 4, 2019

First Posted Date

Sep 9, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2025

Last Update Posted Date

Apr 29, 2025Actual

Name	Class
Hong Kong University of Science and Technology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Alzheimer's disease (AD) is a neurodegenerative disorder with no know cure. The pathogenesis of late onset AD (LOAD) is complex and multifactorial in nature, with multiple susceptibility genes and environmental factors at interplay.

The objective of this study is to improve our understanding of the risk factors of LOAD by conducting an epigenome wide study within patients of LOAD contrasted against their cognitively normal siblings.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
DNA methylation		5 years
RNA-seq microbiome		5 years
Alzheimer's disease Assessment Scale-cognitive subscale (Adas-Cog)		5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Sufficient Cantonese competency for cognitive test
Written informed consent given
Have at least one gender-matched cognitively normal sibling

Exclusion Criteria:

Subjects who refuse blood taking procedure
Do not have a reliable family/caregiver informant (personal contact at least once a month)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Alzheimer's disease patients and normal siblings

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Timothy Kwok	Chinese University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Chinese University of Hong Kong		Hong Kong			Hong Kong

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided