Biomarker-based Alzheimer's Disease Cohort Study (BASIC)

NCT07109999 | Recruiting

• 1 other identifier: 2024347
• Study Type: observational
• Target: 2,835
• Locations: 1 country
• Sites: 1

Brief Summary

This study adopts a prospective cohort design, constructing a single-center cohort by recruiting patients with Alzheimer's disease (AD) who are positive for AD biomarkers. First, the investigators aim to establish a cohort of AD patients with positive biomarkers, thereby reserving suitable patient resources for future AD-related clinical trials. Second, based on the established cohort, the investigators will explore the associations between AD-related biomarkers and clinical manifestations among the elderly population in China, and identify potential risk factors influencing the progression of AD. Third, according to the identified risk factors for AD progression, the investigators will construct a risk early warning model for the progression rate of AD based on biomarkers, in order to achieve early identification and precise prevention and control of the progression risk of AD.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• The event of conversion from mild cognitive impairment to dementia within three years.

  The event of conversion from mild cognitive impairment to dementia within three years. Cognitive status will be assessed using Clinical Dementia Rating scale-Global Score (CDR-GS): mild cognitive impairment: CDR-GS = 0.5; dementia: CDR-GS \> 0.5.

  Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.

Secondary Outcomes (20)

• Hachinski Ischemia Score

  Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.

• Memory - Immediate Recall

  Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.

• Digit Span Test

  Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.

• Trail Making Test (TMT)

  Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.

• Boston Naming Test

  Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.

Study Arms (1)

Patients diagnosed with Alzheimer's disease with AD biomarker positivity.

This cohort recruits patients diagnosed with Alzheimer's disease based on clinical symptoms, neuroimaging features and AD biomarkers. Biomarker positivity is necessary for inclusion.

Other: None-placebo

Interventions

None-placebo OTHER

This study is an observational study, and no interventions will be implemented.

Patients diagnosed with Alzheimer's disease with AD biomarker positivity.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study enrolls individuals aged 40 years or older who are under evaluation or care at Xuanwu Hospital, Capital Medical University. Eligible participants must meet the National Institute on Aging-Alzheimer's Association (NIA-AA) core clinical diagnostic criteria (2011) for Alzheimer's disease (AD)-related mild cognitive impairment or probable AD. All included individuals are required to demonstrate amyloid positivity via validated biomarker testing, such as amyloid positron emission tomography (PET) imaging or cerebrospinal fluid analysis. Participants must also provide written informed consent to participate in the study. Individuals with severe psychiatric or neurological conditions that would preclude their ability to complete standardized assessments or comply with study protocols are excluded from enrollment. This cohort aims to characterize a clinically and biomarker-confirmed AD population for research on disease progression or therapeutic interventions.

You may qualify if:

• (1) Patients aged 40 years or older;
• (2) Visiting Xuanwu Hospital, Capital Medical University;
• (3) Meeting the core clinical diagnostic criteria for Alzheimer's disease (AD) - related mild cognitive impairment or probable AD according to the NIA-AA (2011);
• (4) Amyloid positivity confirmed by amyloid PET or cerebrospinal fluid biomarker tests;
• (5) Providing informed consent.

You may not qualify if:

• (1) Individuals who are unable to complete the assessment due to severe psychological or physiological disorders.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

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

Liyang Liu

CONTACT

17888828131; liuliyang@xwhosp.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: August 7, 2025
• Study Start: January 1, 2019
• Primary Completion (Estimated): December 31, 2050
• Study Completion (Estimated): December 31, 2050
• Last Updated: August 7, 2025

Record last verified: 2025-07

Locations

CN (1)