Behavior and mood symptoms in probable Alzheimer's dementia, grouped by blood p-tau217 results
Compares behavioral symptoms in people with probable Alzheimer's dementia who test p-tau217 negative or positive.
Plain-language title generated from the registry record
Registry title: Study on Clinical Characteristics of Patients With Probable Alzheimer's Dementia Stratified by Blood Biomarkers
Key facts
- Where
- Tianjin, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 55 and 90 years old?
Source: NCT07875998, who can take part
Where in China
- Tianjin Anding Hospital,No. 13 Liulin Road, Hexi District, Tianjin, ChinaTianjin, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tianjin Anding Hospital
- Trial code
- NCT07875998
- Record updated
- 15 October 2026
- Original description
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.Read full original descriptionShow less
Characteristics and Mechanism Research of Probable Alzheimer's Disease With Behavioral and Psychological Symptoms of Dementia With Negative Plasma p-tau217
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.
Inclusion: 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.
Exclusion: Concomitant definite neurological diseases; 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.