Alzheimer DiseaseCHIMGENNCT02681822
Multi-center Imaging Genetics Studies in China
An observational study of Alzheimer Disease and Schizophrenia, run by Tianjin Medical University General Hospital at 1 site in China.
Trial summary
To study the impact of genetic and environmental factors on high-level cognition associated neural circuits among healthy young Chinese Han subjects. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Schizophrenia, Major Depressive Disorders
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy young Chinese Han subjects age 18-30
Who may be able to join
- aged 18-30
- Chinese Han
- right-handed
- without history of neuropsychiatric disease
- no substance addiction
- smoking
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Chunshui Yu, PhD contact
Qiang Xu, PhD contact
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Chunshui Yu, PhD, chunshuiyu@vip.163.com
Qiang Xu, PhD, xuqiang9042@gmail.com
About this study
To study the impact of genetic and environmental factors on high-level cognition associated neural circuits among healthy young Chinese Han subjects.
Read the detailed description
The investigators plan to collect behavioral assessment and environmental factors data,peripheral blood sample, MRI brain images in more than 10,000 healthy young Chinese Han individuals in order to build the pathway from gene to high-level cognitive phenotypes.
- Conditions
- Alzheimer Disease, Schizophrenia, Major Depressive Disorders
- Keywords
- Genome-wide association studies, Environmental factors, Behavioral Assessment, Pathway analysis
- Medical subject headings
- Alzheimer Disease, Schizophrenia, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy young subjects | Healthy young Chinese Han subjects aged 18-30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
Childhood adversities as assessed by Childhood Trauma Questionnaire-Short Form (Chinese Version)
To investigate impact of the adversities in early life of participants on brain structure and function as well as the interaction effect of childhood adversities and genetic variations,such as 5-HTTLPR polymorphism.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startNov 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University Cancer Institute and Hospital, Tianjin Medical University Second Hospital, Tianjin First Central Hospital, Pingjin Hospital,Logistics University of Chinese People's Armed Police Forces, School of Medical Imaging, Tianjin Medical University, Tianjin Huanhu Hospital, Beijing Hospital, Chinese PLA General Hospital, Beijing Tongren Hospital, Xuanwu Hospital, Beijing, Peking Union Medical College Hospital, Beijing Normal University, Chinese Academy of Sciences, The Second Hospital of Hebei Medical University, The First Affiliated Hospital of Shanxi Medical University, Inner Mongolia Medical College Hospital, The First Hospital of Jilin University, First Hospital of China Medical University, The First Affiliated Hospital of Dalian Medical University, RenJi Hospital, Huashan Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Nanjing PLA General Hospital, The First Affiliated Hospital with Nanjing Medical University, Xuzhou Medical University, Second Affiliated Hospital, Zhejiang University, School of Medicine, First Affiliated Hospital of Wenzhou Medical University, The First Affiliated Hospital of Anhui Medical University, Shan dong Medical Imaging Research Institute, Qilu Hospital of Shandong University, Yantai Yuhuangding Hospital, Henan Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, Tongji Hospital, Wuhan University, Xiangya Hospital of Central South University, Central South University, Guangdong Provincial People's Hospital, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, South China Normal University, First Affiliated Hospital Xi'an Jiaotong University, Xijing Hospital, Tang-Du Hospital, LanZhou University, West China Hospital, Second Affiliated Hospital of Wenzhou Medical University, University of Electronic Science and Technology of China, First Affiliated Hospital of Chongqing Medical University, Southwest Hospital, China, The University of Science and Technology of China, Guangdong No.2 Provincial People's Hospital
- Responsible party
- Principal investigator, Chunshui Yu, Tianjin Medical University General Hospital
- Investigators
- Chunshui Yu, PhD, Principal investigator, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681822
- Sponsor's protocol ID
- 81425013
- Acronym
- CHIMGEN
- Status last verified
- Apr 2019
- First submitted
- 7 Feb 2016
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The investigators plan to share the IPD with the member institutes or hospitals after the total completion of the investigation.
Publications
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.
PubMed 21543606Corder 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.
PubMed 8346443
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Imaging Genetics Studies in China
- ClinicalTrials.gov ID
- NCT02681822
- Acronym / sponsor ID
- CHIMGEN / 81425013
- Conditions
- Alzheimer Disease, Schizophrenia, Major Depressive Disorders
- Keywords
- Genome-wide association studies, Environmental factors, Behavioral Assessment, Pathway analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Collaborators
- Tianjin Medical University Cancer Institute and Hospital, Tianjin Medical University Second Hospital, Tianjin First Central Hospital, Pingjin Hospital,Logistics University of Chinese People's Armed Police Forces, School of Medical Imaging, Tianjin Medical University, Tianjin Huanhu Hospital, Beijing Hospital, Chinese PLA General Hospital, Beijing Tongren Hospital, Xuanwu Hospital, Beijing, Peking Union Medical College Hospital, Beijing Normal University, Chinese Academy of Sciences, The Second Hospital of Hebei Medical University, The First Affiliated Hospital of Shanxi Medical University, Inner Mongolia Medical College Hospital, The First Hospital of Jilin University, First Hospital of China Medical University, The First Affiliated Hospital of Dalian Medical University, RenJi Hospital, Huashan Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Nanjing PLA General Hospital, The First Affiliated Hospital with Nanjing Medical University, Xuzhou Medical University, Second Affiliated Hospital, Zhejiang University, School of Medicine, First Affiliated Hospital of Wenzhou Medical University, The First Affiliated Hospital of Anhui Medical University, Shan dong Medical Imaging Research Institute, Qilu Hospital of Shandong University, Yantai Yuhuangding Hospital, Henan Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, Tongji Hospital, Wuhan University, Xiangya Hospital of Central South University, Central South University, Guangdong Provincial People's Hospital, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, South China Normal University, First Affiliated Hospital Xi'an Jiaotong University, Xijing Hospital, Tang-Du Hospital, LanZhou University, West China Hospital, Second Affiliated Hospital of Wenzhou Medical University, University of Electronic Science and Technology of China, First Affiliated Hospital of Chongqing Medical University, Southwest Hospital, China, The University of Science and Technology of China, Guangdong No.2 Provincial People's Hospital
- Study start
- Nov 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 12 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the impact of genetic and environmental factors on high-level cognition associated neural circuits among healthy young Chinese Han subjects.
Detailed description
The investigators plan to collect behavioral assessment and environmental factors data,peripheral blood sample, MRI brain images in more than 10,000 healthy young Chinese Han individuals in order to build the pathway from gene to high-level cognitive phenotypes.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy young subjects | – | –Healthy young Chinese Han subjects aged 18-30 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy young Chinese Han subjects age 18-30
Key inclusion criteria (6 listed)
- aged 18-30
- Chinese Han
- right-handed
- without history of neuropsychiatric disease
- no substance addiction
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brain structure and function measured by MRI scans
Time frame: 2 years
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.
1 secondary outcome
Childhood adversities as assessed by Childhood Trauma Questionnaire-Short Form (Chinese Version)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Background: PubMed 21543606Braskie 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.
- Background: PubMed 8346443Corder 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.
- Individual participant dataSharing planned: Yes. The investigators plan to share the IPD with the member institutes or hospitals after the total completion of the investigation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunshui Yu, PhD contact
Qiang Xu, PhD contact
Chunshui Yu, PhD principal investigator
Tianjin Medical University General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Schizophrenia, run by Tianjin Medical University General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunshui Yu, PhD (chunshuiyu@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain structure and function measured by MRI scans (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02681822, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.