NCT02681822

Brief Summary

To study the impact of genetic and environmental factors on high-level cognition associated neural circuits among healthy young Chinese Han subjects.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 12, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

4.1 years

First QC Date

February 7, 2016

Last Update Submit

April 8, 2019

Conditions

Alzheimer DiseaseSchizophreniaMajor Depressive Disorders

Keywords

Genome-wide association studiesEnvironmental factorsBehavioral AssessmentPathway analysis

Outcome Measures

Primary Outcomes (1)

  • Brain structure and function measured by MRI scans

    The participants will receive non-interventional multi-modal MRI scans, such as 3D-T1WI, DTI, DKI, ASL, REST-fmri, then the investigators can acquire the brain volume in region of interest, such as bilateral hippocampus.

    2 years

Secondary Outcomes (1)

  • Childhood adversities as assessed by Childhood Trauma Questionnaire-Short Form (Chinese Version)

    2 years

Study Arms (1)

Healthy young subjects

Healthy young Chinese Han subjects aged 18-30

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy young Chinese Han subjects age 18-30

You may qualify if:

  • aged 18-30
  • Chinese Han
  • right-handed
  • without history of neuropsychiatric disease
  • no substance addiction
  • smoking

You may not qualify if:

  • younger or elder than 18-30 year-old
  • other ethnics
  • with history of neuropsychiatric disease
  • with history of neuropsychiatric disease among first,second and third degree relatives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

RECRUITING

Related Publications (2)

  • Braskie MN, Jahanshad N, Stein JL, Barysheva M, McMahon KL, de Zubicaray GI, Martin NG, Wright MJ, Ringman JM, Toga AW, Thompson PM. Common Alzheimer's disease risk variant within the CLU gene affects white matter microstructure in young adults. J Neurosci. 2011 May 4;31(18):6764-70. doi: 10.1523/JNEUROSCI.5794-10.2011.

    PMID: 21543606BACKGROUND

  • Corder EH, Saunders AM, Strittmatter WJ, Schmechel DE, Gaskell PC, Small GW, Roses AD, Haines JL, Pericak-Vance MA. Gene dose of apolipoprotein E type 4 allele and the risk of Alzheimer's disease in late onset families. Science. 1993 Aug 13;261(5123):921-3. doi: 10.1126/science.8346443.

    PMID: 8346443BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

The investigators retain the peripheral blood drawn from antecubital vein in order to acquire the genotype, whether the healthy young participants carry the risk allele of one specific gene or not. No matter what genotypes the participants own, no specific intervention measure will be done among the participants.

MeSH Terms

Conditions

Alzheimer DiseaseSchizophreniaDepressive Disorder, Major

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic DisordersDepressive DisorderMood Disorders

Study Officials

  • Chunshui Yu, PhD

    Tianjin Medical University General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunshui Yu, PhD

CONTACT

chunshuiyu@vip.163.com

Qiang Xu, PhD

CONTACT

xuqiang9042@gmail.com

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Radiology and Tianjin Key Laboratory of Functional Imaging

Study Record Dates

First Submitted

February 7, 2016

First Posted

February 12, 2016

Study Start

November 1, 2015

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

April 10, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will share

The investigators plan to share the IPD with the member institutes or hospitals after the total completion of the investigation.

Locations

CN(1)