NCT05055310

Brief Summary

MicroRNAs network, such as MicRNA107 et al, regulate the pathology of Alzheimer's disease and the clinical validation in diagnosis AD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2020

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

September 24, 2021

Completed
Last Updated

September 24, 2021

Status Verified

January 1, 2021

Enrollment Period

3.2 years

First QC Date

January 8, 2020

Last Update Submit

September 21, 2021

Conditions

Alzheimer Disease

Keywords

MicroRNAsAlzheimer's DiseaseValidation

Outcome Measures

Primary Outcomes (1)

  • MicRNAs diagnosis validation for aMCI

    MicRNAs concentration in plasma among three groups

    5 years

Study Arms (3)

Normal elderly

normal cognitive group

Diagnostic Test: MicRNAs test

aMCI

amnestic mild cognitive impairment

Diagnostic Test: MicRNAs test

AD

Alzhiemer's disease

Diagnostic Test: MicRNAs test

Interventions

MicRNAs testDIAGNOSTIC_TEST

plasma micRNAs concentration

ADNormal elderlyaMCI

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

age between 60 to 90 years old.

You may qualify if:

  • NIA-AA MCI due to AD clinical criteria for MCI due to AD
  • NIA-AA AD clinical criteria for AD

You may not qualify if:

  • Other type of dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychogeriatrics，Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2020

First Posted

September 24, 2021

Study Start

October 1, 2016

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

September 24, 2021

Record last verified: 2021-01

Locations

CN(1)