Study on Biomarkers for Early Diagnosis of Alzheimer's Disease

NCT04575337 | Recruiting DMC

• 1 other identifier: Bio-AD
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Alzheimer Disease

Keywords

Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

• A multiple diagnostic kit for early diagnosis of AD.

  A panel of special biomarkers is identified for early diagnosis of AD.

  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.

  An Average of 1 year

Secondary Outcomes (4)

• A panel of biomarker with high specificity and sensibility

  An Average of 1 year

• AD-associated genes in Chinese.

  An Average of 1 year

• Neuroimaging biomarkers for AD

  An Average of 1 year

• Risks and protective factors for AD among elderly in China

  An Average of 1 year

Study Arms (5)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Related Publications (8)

• 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.

  PMID: 31914229 BACKGROUND

• Jia 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.

  PMID: 31494009 BACKGROUND

• Jia 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.

  PMID: 31422798 BACKGROUND

• Qiu 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.

  PMID: 31235344 BACKGROUND

• Shen 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.

  PMID: 31235249 BACKGROUND

• Jia 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.

  PMID: 35109911 RESULT

• Song 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.

  PMID: 36155508 RESULT

• Gong 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.

  PMID: 36003963 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood, cerebral spinal fluid, saliva, and urine

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jianping Jia, Doctor

  Xuanwu Hospital of Capital Medical University

  STUDY CHAIR

Central Study Contacts

Jianping Jia, Doctor

CONTACT

#8610-83199449; jiajp@vip.126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Director

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 5, 2020
• Study Start: May 28, 2020
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

CN (1)