Alzheimer s DiseasePhase 1/2ESCAPE-ADNCT07591727
A Study of the Metabolic Reconstruction Oral Biologics (Gut-X-001) Medication in People With Alzheimer's Disease (ESCAPE-AD)
A Phase 1/2 study testing Gut-X-001 in people with Alzheimer s Disease, run by Beijing Tiantan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer s Disease
- What is being tested?
- Gut-X-001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Formal education of 1 year or less.
- Known history of severe organic disease or an anticipated survival of less than 12 months.
- Pregnant or breastfeeding women, or women of childbearing potential who refuse to use contraceptive measures.
- Participation in another clinical study within 30 days prior to screening, or currently enrolled in another clinical study.
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy, Safety, and Feasibility of Metabolic ReConstruction Oral Biologics (Gut-X-001) in Patients With Alzheimer's Disease: An Exploratory Clinical Trial （ESCAPE-AD）
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.
- Conditions
- Alzheimer s Disease
- Being tested
- Gut-X-001 + Placebo capsule, Gut-X-001, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gut-X-001 + Placebo capsuleDrug
Participants will receive Gut-X-001 orally at a dose of 2 active capsules (10 mg of active ingredient per capsule) plus 2 placebo capsules (0 mg of active ingredient per capsule) per administration, 3 times daily (at 8:00 AM, 12:00 PM, and 10:00 PM), administered before meals and before bedtime. Total active ingredient per administration: 20 mg; total daily dose: 60 mg.
Gut-X-001Drug
Participants will receive Gut-X-001 orally at a dose of 4 active capsules (10 mg of active ingredient per capsule) per administration, 3 times daily (at 8:00 AM, 12:00 PM, and 10:00 PM), administered before meals and before bedtime. Total active ingredient per administration: 40 mg; total daily dose: 120 mg.
PlaceboDrug
Participants will receive 4 placebo capsules (0 mg of active ingredient per capsule) orally per administration, 3 times daily (at 8:00 AM, 12:00 PM, and 10:00 PM), administered before meals and before bedtime. Placebo capsules are identical in appearance to the active Gut-X-001 capsules to maintain blinding.
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose Group | Experimental | Low-Dose Gut-X-001 Receives: Drug: Gut-X-001 + Placebo capsule |
| High-Dose Group | Experimental | High-Dose Gut-X-001 Receives: Drug: Gut-X-001 |
| Control Group | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in ADAS-Cog13 score at Month 6
Change from baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale 13-item version (ADAS-Cog13) score. Higher scores indicate greater cognitive impairment.
Measured: Baseline, Month 6
Secondary outcomes (7)
Change from baseline in ADAS-Cog13 score at Month 12 (OLE)
Change from baseline and from Month 6 in ADAS-Cog13 score during the open-label extension (OLE) phase. Higher scores indicate greater cognitive impairment.
Measured: Baseline, Month 6, Month 12 (OLE)
Change from baseline in ADCS-ADL score at Month 6 and Month 12 (OLE)
Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) scale score. Lower scores indicate greater functional impairment.
Measured: Baseline, Month 6, Month 12 (OLE)
Change from baseline in PSQI score at Month 6 and Month 12 (OLE)
Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) score. Higher scores indicate poorer sleep quality.
Measured: Baseline, Month 6, Month 12 (OLE)
Change from baseline in NPI score at Month 6 and Month 12 (OLE)
Change from baseline in the Neuropsychiatric Inventory (NPI) score. Higher scores indicate more severe neuropsychiatric symptoms.
Measured: Baseline, Month 6, Month 12 (OLE)
Change from baseline in brain volume and hippocampal volume at Month 6 and Month 12 (OLE)
Change from baseline in brain volume and hippocampal volume as measured by structural neuroimaging (MRI).
Measured: Baseline, Month 6, Month 12 (OLE)
Change from baseline in SCD-Q9 score at Month 6 and Month 12 (OLE)
Change from baseline in the Subjective Cognitive Decline Questionnaire 9-item version (SCD-Q9) score.
Measured: Baseline, Month 6, Month 12 (OLE)
Change from baseline in CDR-SB score at Month 6 and Month 12 (OLE)
Change from baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) score. Higher scores indicate greater disease severity.
Measured: Baseline, Month 6, Month 12 (OLE)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer s DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing University of Chemical Technology, Jilin University
- Responsible party
- Principal investigator, yilong Wang, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591727
- Sponsor's protocol ID
- KY2026-015
- Acronym
- ESCAPE-AD
- Status last verified
- Jun 2026
- First submitted
- 11 May 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety, and Feasibility of Metabolic ReConstruction Oral Biologics (Gut-X-001) in Patients With Alzheimer's Disease: An Exploratory Clinical Trial （ESCAPE-AD）
- ClinicalTrials.gov ID
- NCT07591727
- Acronym / sponsor ID
- ESCAPE-AD / KY2026-015
- Conditions
- Alzheimer s Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Beijing University of Chemical Technology, Jilin University
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-Dose Group | Experimental | Drug: Gut-X-001 + Placebo capsuleLow-Dose Gut-X-001 |
| High-Dose Group | Experimental | Drug: Gut-X-001High-Dose Gut-X-001 |
| Control Group | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gut-X-001 + Placebo capsuleParticipants will receive Gut-X-001 orally at a dose of 2 active capsules (10 mg of active ingredient per capsule) plus 2 placebo capsules (0 mg of active ingredient per capsule) per administration, 3 times daily (at 8:00 AM, 12:00 PM, and 10:00 PM), administered before meals and before bedtime. Total active ingredient per administration: 20 mg; total daily dose: 60 mg. | Drug | Low-Dose Group |
| Gut-X-001Participants will receive Gut-X-001 orally at a dose of 4 active capsules (10 mg of active ingredient per capsule) per administration, 3 times daily (at 8:00 AM, 12:00 PM, and 10:00 PM), administered before meals and before bedtime. Total active ingredient per administration: 40 mg; total daily dose: 120 mg. | Drug | High-Dose Group |
| PlaceboParticipants will receive 4 placebo capsules (0 mg of active ingredient per capsule) orally per administration, 3 times daily (at 8:00 AM, 12:00 PM, and 10:00 PM), administered before meals and before bedtime. Placebo capsules are identical in appearance to the active Gut-X-001 capsules to maintain blinding. | Drug | Control Group |
Primary outcome
Change from baseline in ADAS-Cog13 score at Month 6
Time frame: Baseline, Month 6
Change from baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale 13-item version (ADAS-Cog13) score. Higher scores indicate greater cognitive impairment.
7 secondary outcomes
Change from baseline in ADAS-Cog13 score at Month 12 (OLE)
Time frame: Baseline, Month 6, Month 12 (OLE)
Change from baseline in ADCS-ADL score at Month 6 and Month 12 (OLE)
Time frame: Baseline, Month 6, Month 12 (OLE)
Change from baseline in PSQI score at Month 6 and Month 12 (OLE)
Time frame: Baseline, Month 6, Month 12 (OLE)
Change from baseline in NPI score at Month 6 and Month 12 (OLE)
Time frame: Baseline, Month 6, Month 12 (OLE)
Change from baseline in brain volume and hippocampal volume at Month 6 and Month 12 (OLE)
Time frame: Baseline, Month 6, Month 12 (OLE)
Change from baseline in SCD-Q9 score at Month 6 and Month 12 (OLE)
Time frame: Baseline, Month 6, Month 12 (OLE)
Change from baseline in CDR-SB score at Month 6 and Month 12 (OLE)
Time frame: Baseline, Month 6, Month 12 (OLE)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gut-X-001 in people with Alzheimer s Disease, run by Beijing Tiantan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yilong Wang (13911666571, Yilong528@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in ADAS-Cog13 score at Month 6 (time frame: Baseline, Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.