Alzheimer DiseaseNCT07109999
Biomarker-based Alzheimer's Disease Cohort Study (BASIC)
An observational study of Alzheimer Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Alzheimer Disease
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,835 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2050
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- (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.
Who cannot join
- (1) Individuals who are unable to complete the assessment due to severe psychological or physiological disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, 100053
Liu Liyang Liu, 17888828131, liuliyang@xwhosp.org
About this study
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
- Being tested
- None-placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None-placeboOther
This study is an observational study, and no interventions will be implemented.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: None-placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Secondary outcomes (20)
Hachinski Ischemia Score
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.
Measured: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Memory - Immediate Recall
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.
Measured: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Digit Span Test
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.
Measured: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Trail Making Test (TMT)
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.
Measured: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Boston Naming Test
Boston Naming Test quantifies confrontation naming ability by the number of spontaneously correct responses; lower scores indicate lexical-semantic impairment.
Measured: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Memory - Delayed Recall
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.
Measured: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Memory - Cued Recall
Cued Recall evaluates the number of previously learned items correctly retrieved following semantic prompts (range 0-15); lower scores reflect deficient retrieval efficiency.
Measured: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Subjective Cooperation Score
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.
Measured: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Neuropsychiatric Inventory (NPI)
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.
Measured: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Geriatric Depression Scale (GDS)
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.
Measured: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Daily and Overall Functional Assessment
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.
Measured: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Activities of Daily Living (ADL)
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.
Measured: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Clinical events
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.
Measured: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Blood biomarkers
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.
Measured: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Magnetic resonance imaging (MRI) examination
Structural imaging and functional imaging.
Measured: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Electroencephalogram (EEG)
Power of each EEG frequency band
Measured: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Polysomnography
Measured: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Positron Emission Tomography (PET) scan
Brain metabolic imaging and amyloid imaging
Measured: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Cerebrospinal fluid (CSF) examination
Routine and biochemical analysis of cerebrospinal fluid (CSF), as well as the measurement of Aβ and tau proteins
Measured: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Near-infrared brain functional imaging
Measured: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 Jan 2019
- Primary completion31 Dec 2050 (estimated)
- Study completion31 Dec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,835 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109999
- Sponsor's protocol ID
- 2024347
- Status last verified
- Jul 2025
- First submitted
- 25 May 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker-based Alzheimer's Disease Cohort Study (BASIC)
- ClinicalTrials.gov ID
- NCT07109999
- Acronym / sponsor ID
- 2024347
- Conditions
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,835 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2050 (estimated)
- Study completion
- 31 Dec 2050 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with Alzheimer's disease with AD biomarker positivity. | – | Other: None-placeboThis cohort recruits patients diagnosed with Alzheimer's disease based on clinical symptoms, neuroimaging features and AD biomarkers. Biomarker positivity is necessary for inclusion. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- (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.
Key exclusion criteria (1 listed)
- (1) Individuals who are unable to complete the assessment due to severe psychological or physiological disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None-placeboThis study is an observational study, and no interventions will be implemented. | Other | Patients diagnosed with Alzheimer's disease with AD biomarker positivity. |
Primary outcome
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.
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.
20 secondary outcomes
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.
Clinical events
Time frame: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Blood biomarkers
Time frame: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Magnetic resonance imaging (MRI) examination
Time frame: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Electroencephalogram (EEG)
Time frame: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Polysomnography
Time frame: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Positron Emission Tomography (PET) scan
Time frame: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Cerebrospinal fluid (CSF) examination
Time frame: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Near-infrared brain functional imaging
Time frame: Assessments will be conducted every 6 months to 1 year upto 15 years for each participant.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liyang Liu (17888828131, liuliyang@xwhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.