NCT07875998Recruiting
Study on Clinical Characteristics of Patients With Probable Alzheimer's Dementia Stratified by Blood Biomarkers
Characteristics and Mechanism Research of Probable Alzheimer's Disease With Behavioral and Psychological Symptoms of Dementia With Negative Plasma p-tau217
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 8 Sept 2026
- Start date
- 31 Jan 2026
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Tianjin Anding Hospital
- Diseases
- Alzheimer disease
- NCT number
- NCT07875998
What you commit to
- Study type: Observational
- Planned participants: 200
- From 31 Jan 2026 to the primary completion date, 31 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant definite neurological diseases;
Other illness
- Established diagnosis of vascular dementia, frontotemporal dementia, dementia with Lewy bodies, or neurocognitive disorders attributable to other etiologies;
- Presence of severe and unstable somatic diseases involving the respiratory, circulatory, immune, endocrine or other systems.
Who the study is looking for
- Aged between 50 and 90 years, without gender restriction;
- 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);
- Mini-Mental State Examination (MMSE) score \< 24;
- Clinical Dementia Rating (CDR) score \> 0.5;
- Hachinski Ischemic Scale score ≤ 4 (to exclude prominent vascular contributions);
- Understand the entire study procedure; written informed consent is obtained from participants or their legal guardians.
Age in the registry: 55 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Anding Hospital,No. 13 Liulin Road, Hexi District, Tianjin, China Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.