A Study of the Metabolic Reconstruction Oral Biologics (Gut-X-001) Medication in People With Alzheimer's Disease (ESCAPE-AD)

Prior treatment

• Diagnosis of acute cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, myocardial infarction, or heart failure within the 3 months prior to screening.
• Currently receiving medications that may interfere with study outcomes.
• Known hypersensitivity to the investigational drug or any of its excipients.
• Participation in another clinical study within 30 days prior to screening, or currently enrolled in another clinical study.

Other illness

• Presence of other conditions that may contribute to cognitive impairment, including neurological disorders (e.g., vascular cognitive impairment, Parkinson's disease, frontotemporal dementia, Lewy body dementia) or psychiatric and affective disorders (e.g., severe anxiety/depression, schizophrenia).
• Presence of other active or significant neurological conditions, including recurrent epileptic seizures, intracranial space-occupying tumors, vascular malformations (including arteriovenous malformations, arterial malformations, or cavernous malformations), or untreated aneurysms with a diameter \>3 mm.
• Known history of severe organic disease or an anticipated survival of less than 12 months.
• Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment or unable to complete the study procedures and follow-up visits, such as psychiatric illness or physical conditions that preclude compliance with study requirements.

Lab values

• Severe hepatic impairment \[ALT or AST \>3× upper limit of normal (ULN), or concurrent acute hepatitis, chronic active hepatitis, or liver cirrhosis\], renal impairment \[estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m²\], active malignancy, severe anemia, chronic obstructive pulmonary disease (COPD), immune system disorders, uncontrolled diabetes, or uncontrolled hypertension \[systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg\].

Other

• Formal education of 1 year or less.
• Pregnant or breastfeeding women, or women of childbearing potential who refuse to use contraceptive measures.

• Age ≥50 and ≤85 years.
• Diagnosis of Alzheimer's disease confirmed by a qualified neurologist based on the 2024 National Institute on Aging - Alzheimer's Association (NIA-AA) diagnostic criteria, with at least one abnormal core biomarker, including amyloid PET, CSF Aβ42/40, phosphorylated tau181 (p-tau181)/Aβ42, total tau (t-tau)/Aβ42, or plasma p-tau217.
• MMSE score meeting the following criteria:
  • If years of education ≤6: MMSE score between 16 and 24 (inclusive); If years of education \>6: MMSE score between 18 and 27 (inclusive).
• Clinical Dementia Rating (CDR) global score of 0.5 (for MCI due to AD) or 1.0 (for mild AD dementia).
• If receiving acetylcholinesterase inhibitor (AChEI) and/or memantine therapy, the dose must have been stable for at least 3 months prior to screening.
• Participants must have a reliable caregiver who has frequent contact with the participant (at least 4 days per week and at least 2 hours per day). The caregiver must accompany the participant to all study visits, provide meaningful input for scale assessments through sufficient interaction with the participant, and remain consistent throughout the study period wherever possible.
• The participant or their legally authorized representative is able and willing to provide written informed consent.