Detection of Alzheimer's Disease (AD)-Related Seeds for AD Diagnosis

NCT04850053 | Recruiting

• 1 other identifier: AD-seeds-detector
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

The study will investigate the biomarkers of Aβ and Tau seeds in plasma detected by Alzheimer's disease (AD) related seeds quantitative detector (AD-seeds-detector), and their sensitivity and specificity in diagnosing AD, compared with those from age-matched cognitively normal controls, and those with other types of dementia. To perform a high throughput analysis of the amount of Aβ and Tau seeds, the investigators have developed an AD-seeds-detector, in which a fluorescence microplate reader was combined with an oscillating mixer or water-bath-type ultrasonicator.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease

Outcome Measures

Primary Outcomes (1)

• The area under curve of the AD-seeds-detector for the accurate diagnosis of AD

  The area under curve is used to show the ability of the AD-seeds-detector to diagnose AD. The value of area under curve is higher, then the ability of the AD-seeds-detector to diagnose AD is stronger.

  two years

Secondary Outcomes (6)

• The sensitivity

  two years

• The specificity

  two years

• The positive predictive value

  two years

• The negative predictive value

  two years

• Cellular toxcity of Aβ seeds protein

  two years

Study Arms (3)

Alzheimer's disease

Criteria for AD according to the 2011 NIA-AA

Non-AD dementia

Frontotemporal dementia (FTD); or Parkinson's disease dementia (PDD); or dementia with Lewy bodies (DLB); or vascular dementia (VaD); or corticobasal degeneration (CBD); or dementia not otherwise specified.

Cognitively normal controls

Individuals with normal cognitive function

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study one: (1) AD patients (n=150); (2) cognitively normal controls (n=100); (3) non-AD dementia patients (n=50). Study two: (1) AD patients (n=400); (2) cognitively normal controls (n=400); (3) non-AD dementia patients (n=400).

You may qualify if:

• Aged 55-75. Written informed consent obtained from participant or legal guardian prior to any study-related procedures. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. As for non-AD dementia, the McKeith criteria are used for DLB,the revised diagnostic criteria proposed by the International behavioral variant (bvFTD) Criteria Consortium for bvFTD,the Gorno-Tempini criteria for the semantic variant FTD or non-fluent aphasia, the Movement Disorder Society Task Force criteria for PDD, the vascular behavioral and cognitive disorders (Vas-Cog) criteria for VaD, the Armstrong's criteria for CBD, the CDC's diagnostic criteria for CJD, etc. In addition, normal cognition is supported by MMSE, CDR and other cognitive function scales.

You may not qualify if:

• Other medical or psychiatric illness. No one can serve as an informant. Refused to complete a cognitive test and provide biospecimen.

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: collaborator
• Kaifeng Central Hospital: collaborator
• Huashan Hospital: collaborator
• West China Hospital: collaborator
• Henan Provincial People's Hospital: collaborator
• Xiangya Hospital of Central South University: collaborator
• Beijing Geriatric Hospital: collaborator
• The First Affiliated Hospital of Chongqing Medical Universty: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• Capital Medical University: lead
• Shandong Provincial Hospital: collaborator

Study Sites (1)

Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Related Publications (1)

• 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood,cerebral spinal fluid

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

Central Study Contacts

Jianping Jia, Doctor

CONTACT

8610-83199449; jiajp@vip.126.com

Study Design

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

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 20, 2021
• Study Start: August 26, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

CN (1)