Alzheimer DiseaseNCT04575337
Study on Biomarkers for Early Diagnosis of Alzheimer's Disease
An observational study of Alzheimer Disease, run by Capital Medical University at 1 site in China.
Trial summary
The project of Bio-AD is a population- based cohort study among the elderly in China. The project includes not only Alzheimer's disease (AD including familial AD and sporadic AD), but also other clinical stage of AD, as well as elderly people with normal cognitive function. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- How many people
- 6,000 participants
- Where
- 1 siteChina
- Study dates
- 28 May 2020to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population was calculated according to objectives of this project. There are five gruops in this cohort, AD, MCI, pre-MCI, normal cognitive subjects and other neurodegenerative disease, respectively. AD gruop include familial AD and sporadic AD. The study population include subjects at different clinical stages of AD.
Who may be able to join
- Written informed consent obtained from participant or legal guardian prior to any study-related procedures.
- Aged 18 (inclusive) or older.
- Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-R). The diagnosis of AD is made using the National Institute of Neurologic and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS- ADRDA) or National Institute on Aging and the Alzheimer's Assocation (NIA-AA) criteria. A diagnosis of mild cognitive impairment (MCI) is assigned according to Petersen criteria. A diagnosis of pre-MCI group is assigned by β-Amyloid positive or APOE ε4 carrier or complains of cognitive impairment, but not up to MCI or cognitive impairment. Normal cognitive function assessed/evaluated by MMSE, CDR and other cognitive function scales.
- Follow up 5 years and collect the information.
Who cannot join
- Under age 18.
- Medical or psychiatric illness that would interfere in completing initial and follow-up visits.
- No one can serve as a study informant.
- With current or past neurological or psychiatric illnesses such as schizophrenia, epilepsy, brain tumors, severe head trauma and other diseases which can induce dementia.
- Refused to complete a cognitive test and provide biospecimen.
- With history of alcohol or drug abuse.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, 100053
Jianping Jia, Doctor
About this study
Official title: Study on Body Fluid, Gene and Neuroimaging Biomarkers for Early Diagnosis of Alzheimer's Disease
The project of Bio-AD is a population- based cohort study among the elderly in China.
The project includes not only Alzheimer's disease (AD including familial AD and sporadic AD), but also other clinical stage of AD, as well as elderly people with normal cognitive function.
Read more
The project will collect, detect and screen the special biomarkers at different clinical stage of AD based on body fluid, gene and brain image. The standard and consistent assessment protocols are employed to obtain clinical, cognitive, genetic, neuroimaging and biospecimen data.
The purpose of this project is to establish a panel of biomarkers which could be used to diagnose AD at the early stage, and to establish a risk prediction models for AD to predict the 5-years risk of the onset and progression of AD among elderly population in China.
Read the detailed description
- Set up a large population- based cohort including AD, MCI, pre-MCI, other neurodegenerative diseases, and elderly individuals with normal cognitive function.
- Collect the information of clinical and neuropsychological assessment, individual traits and social environmental factors, and neuroimaging data, as well as the biological samples, such as peripheral blood and cerebrospinal fluid.
- Screen biomarkers with high specificity and sensitivity from peripheral blood, cerebrospinal fluid and neuroimaging to distinguish different clinical stages of AD at baseline.
- Screen the AD-associated gene and their risk variants.
- Establish a panel of AD-specific biomarkers for the preliminary development of diagnostic kit.
- Identify AD-relevant factors and the special biomarkers to create a preliminary risk models to predict the onset and progression of AD.
- Follow up the cohort for next 5 years and collect the multiple information and biological samples each year to validate and revise the risk prediction models and the diagnostic kit of AD.
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer Disease
- Medical subject headings
- Alzheimer Disease
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 |
|---|---|---|
| AD group | Dementia is diagnosed according to the 2011 NIA-AA criteria. | |
| MCI group | aMCI diagnosed according to the criteria of 2004 Peterson. | |
| pre-MCI group | β-Amyloid positive or APOE ε4 carrier or complains of cognitive impairment; not up to MCI or cognitive impairment. | |
| Other neurodegenerative diseases | Frontotemporal Dementia; or Parkinson's disease | |
| Cognitive normal group | Individuals are with normal cognitive function and ≥ 60 years old. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A multiple diagnostic kit for early diagnosis of AD.
A panel of special biomarkers is identified for early diagnosis of AD.
Measured: An Average of 1 year
A 5-years risk prediction model for onset and progression of AD among elderly population in China.
A 5-years risk prediction model including multiple factors to predict the onset and progression of AD in China.
Measured: An Average of 1 year
Secondary outcomes (4)
A panel of biomarker with high specificity and sensibility
Screening the biomarker with high specificity and sensibility in body fluid at different clinical stage of AD.
Measured: An Average of 1 year
AD-associated genes in Chinese.
AD-associated genes and their risk variants will be identified by whole exome sequencing in this project.
Measured: An Average of 1 year
Neuroimaging biomarkers for AD
The certain threshold on neuroimaging biomarkers will be established to distinguish the different clinical stage of AD.
Measured: An Average of 1 year
Risks and protective factors for AD among elderly in China
The risks and protective factors of individual and environment will be estimated in this project.
Measured: An Average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start28 May 2020
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianping Jia, Capital Medical University
- Investigators
- Jianping Jia, Doctor, Study chair, Xuanwu Hospital of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575337
- Sponsor's protocol ID
- Bio-AD
- Status last verified
- Mar 2026
- First submitted
- 29 Sep 2020
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jia L, Fu Y, Shen L, Zhang H, Zhu M, Qiu Q, Wang Q, Yan X, Kong C, Hao J, Wei C, Tang Y, Qin W, Li Y, Wang F, Guo D, Zhou A, Zuo X, Yu Y, Li D, Zhao L, Jin H, Jia J. PSEN1, PSEN2, and APP mutations in 404 Chinese pedigrees with familial Alzheimer's disease. Alzheimers Dement. 2020 Jan;16(1):178-191. doi: 10.1002/alz.12005.
PubMed 31914229Jia L, Quan M, Fu Y, Zhao T, Li Y, Wei C, Tang Y, Qin Q, Wang F, Qiao Y, Shi S, Wang YJ, Du Y, Zhang J, Zhang J, Luo B, Qu Q, Zhou C, Gauthier S, Jia J; Group for the Project of Dementia Situation in China. Dementia in China: epidemiology, clinical management, and research advances. Lancet Neurol. 2020 Jan;19(1):81-92. doi: 10.1016/S1474-4422(19)30290-X. Epub 2019 Sep 4.
PubMed 31494009Jia L, Qiu Q, Zhang H, Chu L, Du Y, Zhang J, Zhou C, Liang F, Shi S, Wang S, Qin W, Wang Q, Li F, Wang Q, Li Y, Shen L, Wei Y, Jia J. Concordance between the assessment of Abeta42, T-tau, and P-T181-tau in peripheral blood neuronal-derived exosomes and cerebrospinal fluid. Alzheimers Dement. 2019 Aug;15(8):1071-1080. doi: 10.1016/j.jalz.2019.05.002.
PubMed 31422798Qiu Q, Jia L, Wang Q, Zhao L, Jin H, Li T, Quan M, Xu L, Li B, Li Y, Jia J. Identification of a novel PSEN1 Gly111Val missense mutation in a Chinese pedigree with early-onset Alzheimer's disease. Neurobiol Aging. 2020 Jan;85:155.e1-155.e4. doi: 10.1016/j.neurobiolaging.2019.05.018. Epub 2019 May 31.
PubMed 31235344Shen L, Qin W, Wu L, Zhou A, Tang Y, Wang Q, Jia L, Jia J. Two novel presenilin-1 mutations (I249L and P433S) in early onset Chinese Alzheimer's pedigrees and their functional characterization. Biochem Biophys Res Commun. 2019 Aug 13;516(1):264-269. doi: 10.1016/j.bbrc.2019.05.185. Epub 2019 Jun 21.
PubMed 31235249Jia J, Li T, Yang J, Chen B, Qin W, Wei C, Song Y, Wang Q, Li Y, Jia L. Detection of plasma Abeta seeding activity by a newly developed analyzer for diagnosis of Alzheimer's disease. Alzheimers Res Ther. 2022 Feb 2;14(1):21. doi: 10.1186/s13195-022-00964-2.
PubMed 35109911Song Y, Quan M, Li T, Jia J. Serum Homocysteine, Vitamin B12, Folate, and Their Association with Mild Cognitive Impairment and Subtypes of Dementia. J Alzheimers Dis. 2022;90(2):681-691. doi: 10.3233/JAD-220410.
PubMed 36155508Gong M, Jia J. Contribution of blood-brain barrier-related blood-borne factors for Alzheimer's disease vs. vascular dementia diagnosis: A pilot study. Front Neurosci. 2022 Aug 8;16:949129. doi: 10.3389/fnins.2022.949129. eCollection 2022.
PubMed 36003963
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Body Fluid, Gene and Neuroimaging Biomarkers for Early Diagnosis of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04575337
- Acronym / sponsor ID
- Bio-AD
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 28 May 2020 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 5 Oct 2020 (actual)
- 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.
The project of Bio-AD is a population- based cohort study among the elderly in China.
The project includes not only Alzheimer's disease (AD including familial AD and sporadic AD), but also other clinical stage of AD, as well as elderly people with normal cognitive function.
The project will collect, detect and screen the special biomarkers at different clinical stage of AD based on body fluid, gene and brain image. The standard and consistent assessment protocols are employed to obtain clinical, cognitive, genetic, neuroimaging and biospecimen data.
The purpose of this project is to establish a panel of biomarkers which could be used to diagnose AD at the early stage, and to establish a risk prediction models for AD to predict the 5-years risk of the onset and progression of AD among elderly population in China.
Detailed description
- Set up a large population- based cohort including AD, MCI, pre-MCI, other neurodegenerative diseases, and elderly individuals with normal cognitive function.
- Collect the information of clinical and neuropsychological assessment, individual traits and social environmental factors, and neuroimaging data, as well as the biological samples, such as peripheral blood and cerebrospinal fluid.
- Screen biomarkers with high specificity and sensitivity from peripheral blood, cerebrospinal fluid and neuroimaging to distinguish different clinical stages of AD at baseline.
- Screen the AD-associated gene and their risk variants.
- Establish a panel of AD-specific biomarkers for the preliminary development of diagnostic kit.
- Identify AD-relevant factors and the special biomarkers to create a preliminary risk models to predict the onset and progression of AD.
- Follow up the cohort for next 5 years and collect the multiple information and biological samples each year to validate and revise the risk prediction models and the diagnostic kit of AD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| AD group | – | –Dementia is diagnosed according to the 2011 NIA-AA criteria. |
| MCI group | – | –aMCI diagnosed according to the criteria of 2004 Peterson. |
| pre-MCI group | – | –β-Amyloid positive or APOE ε4 carrier or complains of cognitive impairment; not up to MCI or cognitive impairment. |
| Other neurodegenerative diseases | – | –Frontotemporal Dementia; or Parkinson's disease |
| Cognitive normal group | – | –Individuals are with normal cognitive function and ≥ 60 years old. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population was calculated according to objectives of this project. There are five gruops in this cohort, AD, MCI, pre-MCI, normal cognitive subjects and other neurodegenerative disease, respectively. AD gruop include familial AD and sporadic AD. The study population include subjects at different clinical stages of AD.
Key inclusion criteria (4 listed)
- Written informed consent obtained from participant or legal guardian prior to any study-related procedures.
- Aged 18 (inclusive) or older.
- Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-R). The diagnosis of AD is made using the National Institute of Neurologic and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS- ADRDA) or National Institute on Aging and the Alzheimer's Assocation (NIA-AA) criteria. A diagnosis of mild cognitive impairment (MCI) is assigned according to Petersen criteria. A diagnosis of pre-MCI group is assigned by β-Amyloid positive or APOE ε4 carrier or complains of cognitive impairment, but not up to MCI or cognitive impairment. Normal cognitive function assessed/evaluated by MMSE, CDR and other cognitive function scales.
- Follow up 5 years and collect the information.
Key exclusion criteria (6 listed)
- Under age 18.
- Medical or psychiatric illness that would interfere in completing initial and follow-up visits.
- No one can serve as a study informant.
- With current or past neurological or psychiatric illnesses such as schizophrenia, epilepsy, brain tumors, severe head trauma and other diseases which can induce dementia.
- Refused to complete a cognitive test and provide biospecimen.
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
A multiple diagnostic kit for early diagnosis of AD.
Time frame: An Average of 1 year
A panel of special biomarkers is identified for early diagnosis of AD.
A 5-years risk prediction model for onset and progression of AD among elderly population in China.
Time frame: An Average of 1 year
A 5-years risk prediction model including multiple factors to predict the onset and progression of AD in China.
4 secondary outcomes
A panel of biomarker with high specificity and sensibility
Time frame: An Average of 1 year
AD-associated genes in Chinese.
Time frame: An Average of 1 year
Neuroimaging biomarkers for AD
Time frame: An Average of 1 year
Risks and protective factors for AD among elderly in China
Time frame: An Average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Background: PubMed 31914229Jia L, Fu Y, Shen L, Zhang H, Zhu M, Qiu Q, Wang Q, Yan X, Kong C, Hao J, Wei C, Tang Y, Qin W, Li Y, Wang F, Guo D, Zhou A, Zuo X, Yu Y, Li D, Zhao L, Jin H, Jia J. PSEN1, PSEN2, and APP mutations in 404 Chinese pedigrees with familial Alzheimer's disease. Alzheimers Dement. 2020 Jan;16(1):178-191. doi: 10.1002/alz.12005.
- Background: PubMed 31494009Jia L, Quan M, Fu Y, Zhao T, Li Y, Wei C, Tang Y, Qin Q, Wang F, Qiao Y, Shi S, Wang YJ, Du Y, Zhang J, Zhang J, Luo B, Qu Q, Zhou C, Gauthier S, Jia J; Group for the Project of Dementia Situation in China. Dementia in China: epidemiology, clinical management, and research advances. Lancet Neurol. 2020 Jan;19(1):81-92. doi: 10.1016/S1474-4422(19)30290-X. Epub 2019 Sep 4.
- Background: PubMed 31422798Jia L, Qiu Q, Zhang H, Chu L, Du Y, Zhang J, Zhou C, Liang F, Shi S, Wang S, Qin W, Wang Q, Li F, Wang Q, Li Y, Shen L, Wei Y, Jia J. Concordance between the assessment of Abeta42, T-tau, and P-T181-tau in peripheral blood neuronal-derived exosomes and cerebrospinal fluid. Alzheimers Dement. 2019 Aug;15(8):1071-1080. doi: 10.1016/j.jalz.2019.05.002.
- Background: PubMed 31235344Qiu Q, Jia L, Wang Q, Zhao L, Jin H, Li T, Quan M, Xu L, Li B, Li Y, Jia J. Identification of a novel PSEN1 Gly111Val missense mutation in a Chinese pedigree with early-onset Alzheimer's disease. Neurobiol Aging. 2020 Jan;85:155.e1-155.e4. doi: 10.1016/j.neurobiolaging.2019.05.018. Epub 2019 May 31.
- Background: PubMed 31235249Shen L, Qin W, Wu L, Zhou A, Tang Y, Wang Q, Jia L, Jia J. Two novel presenilin-1 mutations (I249L and P433S) in early onset Chinese Alzheimer's pedigrees and their functional characterization. Biochem Biophys Res Commun. 2019 Aug 13;516(1):264-269. doi: 10.1016/j.bbrc.2019.05.185. Epub 2019 Jun 21.
- Results publication: PubMed 35109911Jia J, Li T, Yang J, Chen B, Qin W, Wei C, Song Y, Wang Q, Li Y, Jia L. Detection of plasma Abeta seeding activity by a newly developed analyzer for diagnosis of Alzheimer's disease. Alzheimers Res Ther. 2022 Feb 2;14(1):21. doi: 10.1186/s13195-022-00964-2.
- Results publication: PubMed 36155508Song Y, Quan M, Li T, Jia J. Serum Homocysteine, Vitamin B12, Folate, and Their Association with Mild Cognitive Impairment and Subtypes of Dementia. J Alzheimers Dis. 2022;90(2):681-691. doi: 10.3233/JAD-220410.
- Results publication: PubMed 36003963Gong M, Jia J. Contribution of blood-brain barrier-related blood-borne factors for Alzheimer's disease vs. vascular dementia diagnosis: A pilot study. Front Neurosci. 2022 Aug 8;16:949129. doi: 10.3389/fnins.2022.949129. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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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.
Jianping Jia, Doctor study chair
Xuanwu Hospital of Capital Medical University
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, run by Capital Medical University 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 23 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianping Jia, Doctor (#8610-83199449, jiajp@vip.126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A multiple diagnostic kit for early diagnosis of AD. (time frame: An Average of 1 year). The study lists 2 primary outcomes in all. 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 NCT04575337, which also lists 8 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 23 Mar 2026.