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

Recruiting

• Conditions: Alzheimer Disease

• Registration Number: NCT07109999
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2025-05-25
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-31
• Last Update Submitted: 2025-07-31
• Study First Posted: 2025-08-07
• Last Update Posted: 2025-08-07
• Primary Completion: 2050-12-31
• Study Completion: 2050-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2835

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The event of conversion from mild cognitive impairment to dementia within three years.	Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.	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.

Secondary Outcome Measures

Name	Time	Method
Hachinski Ischemia Score	Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.	The Hachinski Ischemic Score (HIS) is a brief 13-item scale (range 0-18) in which scores ≤4 favor Alzheimer's disease and ≥7 suggest vascular dementia, based on clinical features such as abrupt onset, vascular risk factors, and focal neurological signs.
Memory - Immediate Recall	Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.	Immediate Recall assesses short-term auditory-verbal memory by recording the number of words correctly repeated after a single presentation (typically 0-15); lower scores indicate poorer encoding.
Digit Span Test	Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.	Digit Span Test quantifies auditory-verbal working memory via the longest sequence of digits correctly repeated forward (attention) and backward (manipulation); score = maximum span length.
Trail Making Test (TMT)	Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.	Trail Making Test (TMT) measures processing speed and executive function via completion time (seconds) for Part A (number sequencing) and Part B (alternating numbers-letters); higher scores indicate poorer performance.
Boston Naming Test	Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.	Boston Naming Test quantifies confrontation naming ability by the number of spontaneously correct responses; lower scores indicate lexical-semantic impairment.
Memory - Delayed Recall	Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.	Delayed Recall quantifies the number of previously learned items correctly reproduced after a ≥20-minute unfilled interval (range 0-15); lower scores signal impaired consolidation.
Memory - Cued Recall	Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.	Cued Recall evaluates the number of previously learned items correctly retrieved following semantic prompts (range 0-15); lower scores reflect deficient retrieval efficiency.
Subjective Cooperation Score	Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.	Subjective Cooperation Score is a single-item rater judgment (0-10 scale) quantifying participant engagement and compliance during cognitive testing; higher values denote greater cooperation.
Neuropsychiatric Inventory (NPI)	Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.	The Neuropsychiatric Inventory (NPI) is a validated informant-based scale assessing 12 neuropsychiatric domains (range 0-144); higher scores denote greater symptom frequency and severity.
Geriatric Depression Scale (GDS)	Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.	The 15-item Geriatric Depression Scale (GDS-15) is a self-report screen for depressive symptoms in older adults; total score 0-15, with ≥5 indicating probable depression.
Daily and Overall Functional Assessment	Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.	Daily and Overall Functional Assessment quantifies independence in basic and instrumental activities of daily living (ADL/IADL) via standardized informant or performance-based scales; higher scores denote greater functional ability.
Activities of Daily Living (ADL)	Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.	The Activities of Daily Living (ADL) Scale is a brief, validated instrument that rates independence in basic self-care tasks; scores range from 0 (total dependence) to 6 (full independence), with lower values indicating greater functional impairment.
Clinical events	Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.	The events of transitioning from mild dementia to moderate dementia, and from moderate dementia to severe dementia.Cognitive status will be assessed using Clinical Dementia Rating scale-Global Score (CDR-GS): mild cognitive impairment: CDR-GS = 0.5; moderate dementia: CDR-GS = 2; severe dementia: CDR-GS = 3.
Blood biomarkers	Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.	Amyloid-beta (Aβ), tau, neurofilament light chain protein (NFL), brain-derived neurotrophic factor (BDNF), glial fibrillary acidic protein (GFAP), and markers related to chronic inflammation, etc.
Magnetic resonance imaging (MRI) examination	Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.	Structural imaging and functional imaging.
Electroencephalogram (EEG)	Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.	Power of each EEG frequency band
Polysomnography	Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Positron Emission Tomography (PET) scan	Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.	Brain metabolic imaging and amyloid imaging
Cerebrospinal fluid (CSF) examination	Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.	Routine and biochemical analysis of cerebrospinal fluid (CSF), as well as the measurement of Aβ and tau proteins
Near-infrared brain functional imaging	Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.

Trial Locations

Locations (1)

Xuanwu Hospital of Capital Medical University; 🇨🇳 Beijing, Beijing, China