NCT07875998 Study on Clinical Characteristics of Patients With Probable Alzheimer's Dementia Stratified by Blood Biomarkers
| NCT ID | NCT07875998 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tianjin Anding Hospital |
| Condition | Alzheimer's Disease Dementia |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-01-31 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2026-01-31 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective, observational cohort study. The primary objective is to characterize the clinical features and mechanisms of behavioral and psychological symptoms of dementia (BPSD) in patients with probable Alzheimer's disease (AD) who are plasma p-Tau217 negative, and to compare them with p-Tau217-positive patients. After grouping participants by an authoritative p-Tau217 cutoff value, the negative and positive groups will be systematically compared across all 12 domains of the Neuropsychiatric Inventory (NPI). Participants will be followed up at 6, 12, and 18 months to compare the incidence of cognitive decline, new-onset severe BPSD (hallucinations, agitation/aggression, depression, etc.), cerebrovascular events, and hospitalization between the two groups. As an exploratory objective, baseline BPSD domains combined with imaging (white matter hyperintensity burden) and blood biomarkers (NfL, IL-6, GFAP, etc.) will be used to construct a simple prognostic risk-stratification model within the negative group and to validate its predictive performance. The study aims to improve the recognition of non-AD-driven dementia with overlapping clinical presentations, thereby informing clinical management and care planning in the era of biology-based AD diagnosis.
Eligibility Criteria
Inclusion Criteria: 1. Aged between 50 and 90 years, without gender restriction; 2. Meet the diagnostic criteria for probable Alzheimer's disease dementia (probable AD) proposed by the National Institute on Aging and Alzheimer's Association (2011 NIA-AA); 3. Mini-Mental State Examination (MMSE) score \< 24; 4. Clinical Dementia Rating (CDR) score \> 0.5; 5. Hachinski Ischemic Scale score ≤ 4 (to exclude prominent vascular contributions); 6. Understand the entire study procedure; written informed consent is obtained from participants or their legal guardians. Exclusion Criteria: 1. Established diagnosis of vascular dementia, frontotemporal dementia, dementia with Lewy bodies, or neurocognitive disorders attributable to other etiologies; 2. Concomitant definite neurological diseases; 3. Presence of severe and unstable somatic diseases involving the respiratory, circulatory, immune, endocrine or other systems.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07875998 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 90 Years, studying Alzheimer's Disease Dementia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07875998 currently recruiting?
Yes, NCT07875998 is actively recruiting participants. Contact the research team at lixue_cat860118@163.com for enrollment information.
Where is the NCT07875998 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07875998 clinical trial?
NCT07875998 is sponsored by Tianjin Anding Hospital. The trial plans to enroll 200 participants.
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