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Recruiting NCT07109999

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

— Observational Alzheimer Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: None-placebo.
Who it may be relevant to
Registry conditions: Alzheimer Disease. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other None-placebo
    This study is an observational study, and no interventions will be implemented.

Primary outcome measures

  • The event of conversion from mild cognitive impairment to dementia within three years. [Time frame: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.]
Secondary outcome measures (12)
  • Hachinski Ischemia Score [Time frame: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.]
  • Memory - Immediate Recall [Time frame: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.]
  • Digit Span Test [Time frame: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.]
  • Trail Making Test (TMT) [Time frame: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.]
  • Boston Naming Test [Time frame: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.]
  • Memory - Delayed Recall [Time frame: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.]
  • Memory - Cued Recall [Time frame: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.]
  • Subjective Cooperation Score [Time frame: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.]
  • Neuropsychiatric Inventory (NPI) [Time frame: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.]
  • Geriatric Depression Scale (GDS) [Time frame: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.]
  • Daily and Overall Functional Assessment [Time frame: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.]
  • Activities of Daily Living (ADL) [Time frame: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.]

Eligibility criteria

Inclusion criteria

  • (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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Xuanwu Hospital of Capital Medical University — Beijing

Identifiers

NCT: NCT07109999 · 2024347

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗