Study on Clinical Characteristics of Patients With Probable Alzheimer's Dementia Stratified by Blood Biomarkers

NCT07875998 | Recruiting DMC

• 1 other identifier: Lunke Kuaishen No. 2026-30
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease Dementia

Outcome Measures

Primary Outcomes (3)

• Neuropsychiatric Inventory (NPI)

  The total score ranges from 0 to 144. Higher scores indicate more severe neuropsychiatric/behavioral symptoms (worse outcome).

  0Month、6Month、12Month、18Month

• Mini-Mental State Examination（MMSE）

  Score range: 0-30. Higher scores mean better outcome (better cognitive performance).

  0Month、6Month、12Month、18Month

• Montreal Cognitive Assessment（MoCA）

  Score range: 0-30. Higher scores mean better outcome (superior cognitive performance).

  0Month、6Month、12Month、18Month

Study Arms (1)

study group

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;

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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)

You may qualify if:

• 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.

You may not qualify if:

• Established diagnosis of vascular dementia, frontotemporal dementia, dementia with Lewy bodies, or neurocognitive disorders attributable to other etiologies;
• Concomitant definite neurological diseases;
• Presence of severe and unstable somatic diseases involving the respiratory, circulatory, immune, endocrine or other systems.

Sponsors & Collaborators

• Tianjin Anding Hospital: lead

Study Sites (1)

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

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

Central Study Contacts

Fengfeng Bai, Doctor

CONTACT

+86 88188156; lixue_cat860118@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief psychiatrist

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: October 15, 2026
• Study Start: January 31, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2031
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)