Alzheimer's disease dementia: see how blood biomarkers like p-Tau217 relate to behavioral symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter prospective observational cohort study conducted at Tianjin Anding Hospital. Participants with probable Alzheimer's disease dementia will be stratified by plasma p-Tau217 status (negative, positive, and grey-zone) using validated cutoffs. Baseline assessments include cognitive scales, neuropsychiatric profiling, imaging, and blood biomarkers, with follow-up at 6, 12, and 18 months to compare progression of cognitive decline, new severe behavioral and psychological symptoms, cerebrovascular events, and hospitalizations across groups. An exploratory objective will build a simple risk stratification model combining baseline BPSD, white-matter changes, and blood biomarkers. Participants will receive standard clinical care without study-mandated treatments.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tianjin Anding Hospital,No. 13 Liulin Road, Hexi District, Tianjin, China
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Fengfeng Bai, Doctor
• Email: lixue_cat860118@163.com
• Phone: +86 88188156

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.