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Association Between APOE4 Genotype and Gut Microbiota Interaction in the Progression of Alzheimer’s Disease: A Single-Center ProspectiveCohort Study

Association Between APOE4 Genotype and Gut Microbiota Interaction in the Progression of Alzheimer’s Disease: A Single-Center ProspectiveCohort Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600126349
Enrollment
Unknown
Registered
2026-06-08
Start date
2026-06-23
Completion date
Unknown
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurodegenerative disease

Interventions

cognitively normal individuals group:None

Sponsors

Affiliated Hospital of Guangdong Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for AD (SCD, MCI, or mild dementia: biomarkers supporting AD) or cognitively normal (CN) individuals; 2. Agree to provide fecal and plasma samples for testing, as well as imaging data, and be willing to undergo follow-up. 3. Participants voluntarily enroll in the study and provide written informed consent. For patients lacking full legal capacity, consent must be provided by their legal guardian.

Exclusion criteria

Exclusion criteria: 1. Individuals who have used broad-spectrum antibiotics within the past 2 months. 2. Individuals who have undergone bowel preparation within the past 2 months, or have inflammatory bowel disease, recent infection, or immunosuppressive therapy that may affect the study results; 3. Presence of serious diseases that may affect the study results (e.g., active malignancy, severe hepatic or renal insufficiency, severe cardiovascular disease, serious infectious diseases, etc.); 4. Participants whose blood or stool samples are of inadequate volume, poor quality, or cannot be analyzed due to technical issues. 5. Participants who cannot adhere to the study protocol or are likely to discontinue participation prematurely, including those with severe psychiatric disorders or language/communication impairments; 6. Participants who decline to provide informed consent, or individuals whose involvement in the study raises legal or ethical concerns. 7. Other conditions that the investigator determines make the participant unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
APOE genotype;Clinical Dementia Rating Scale Sum of Boxes, CDR-SB;Composition and diversity of gut microbiota;

Secondary

MeasureTime frame
Mini-Mental State Examination, MMSE;Brain MRI;Body Composition;Ptau181? Ptau217?GFAP?Nfl?Aß42/40 in serum;MoCA;

Countries

China

Contacts

Public ContactLiu Zhou

Affiliated Hospital of Guangdong Medical University

liuzhou102@126.com+86 759 238 7612

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 21, 2026