A Study of the Metabolic Reconstruction Oral Biologics (Gut-X-001) Medication in People With Alzh… (NCT07591727) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Study of the Metabolic Reconstruction Oral Biologics (Gut-X-001) Medication in People With Alzheimer's Disease (ESCAPE-AD)
120 participantsStarted 2026-08-01
Plain-language summary
This is an exploratory clinical trial aimed at preliminarily evaluating the efficacy, safety, and feasibility of orally administered Gut-X-001 in patients with Alzheimer's disease (AD). An open-label extension (OLE) study will also be conducted to further investigate the effects of Gut-X-001. The study will assess the effects of Gut-X-001 on cognitive function, activities of daily living, neuroimaging indicators, and AD-related plasma biomarkers in AD patients. Safety will be systematically monitored, including the incidence of adverse events and changes in hematological and organ function parameters. Furthermore, the study will explore the regulatory effects of Gut-X-001 versus placebo on venous blood redox-related indicators and gut microbiota metabolite levels at different time points, providing a basis for multi-target intervention strategies and offering systematic evidence for the scientific rationale, feasibility, and safety of Gut-X-001 in the clinical management of AD.
Who can participate
Age range
50 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since ESCAPE-AD is a Phase 1/2 trial that hasn't started recruiting yet, what does that mean for what we currently know about the safety and effectiveness of Gut-X-001 in people with Alzheimer's disease?
2This trial measures changes in the ADAS-Cog13 cognitive score over 6 months — is that timeframe long enough to tell us something meaningful about whether this approach might help with my specific stage of Alzheimer's?
3Gut-X-001 is described as a 'metabolic reconstruction oral biologic' targeting the gut — can you explain what that means in the context of Alzheimer's treatment, and how it differs from approaches I might already be on or considering?
4Because the trial isn't recruiting yet, should we be pursuing standard-of-care options now, and could starting those affect whether I'd be eligible to join this study later if we decide it's worth pursuing?
5What questions would you want answered before recommending I consider enrolling in an early-phase trial like this one, given everything you know about my current health and how my Alzheimer's has progressed?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in ADAS-Cog13 score at Month 6
. The participant or their legally authorized representative is able and willing to provide written informed consent.
Exclusion criteria
. 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).
. Diagnosis of acute cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, myocardial infarction, or heart failure within the 3 months prior to screening.
. 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.
. 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 \[systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg\].
. Currently receiving medications that may interfere with study outcomes.
. Known hypersensitivity to the investigational drug or any of its excipients.
. Formal education of 1 year or less.
. Known history of severe organic disease or an anticipated survival of less than 12 months.