The Effect of CB-Exo-A600 in Mild to Moderate Alzheimer's Disease (NCT07457125) | Clinical Trial Compass
RecruitingPhase 1/2
The Effect of CB-Exo-A600 in Mild to Moderate Alzheimer's Disease
China33 participantsStarted 2026-05-30
Plain-language summary
This study is divided into two phases: a dose-escalation phase and an expansion cohort phase. The dose-escalation phase is a single-center study, while the expansion cohort phase is a multicenter, prospective, randomized, double-blind, placebo-controlled study.
Who can participate
Age range
50 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 years, male or female.
* Clinical diagnosis of AD (mild to moderate stage, corresponding to clinical stage 4-5 at screening according to the 2024 National Institute on Aging/Alzheimer's Association \[NIA/AA\] criteria).
* Patients with cerebrospinal fluid biomarker data supporting an AD diagnosis within the past 3 years, or a positive amyloid Positron Emission Tomography (PET) scan result within the past 3 years, or a plasma p-tau217 test result indicating brain amyloid positivity.
* Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan performed within 6 months prior to screening shows findings consistent with the clinical diagnosis of mild to moderate AD and no other clinically significant comorbid pathologies, particularly cerebrovascular disease. If an MRI or CT scan is not available within the 6 months prior to screening, an MRI must be completed and results confirmed before the subject initiates treatment.
* Modified Hachinski Ischemic Score (mHIS) ≤ 4.
* Mini-Mental Status Examination (MMSE) score between 10 and 24 (inclusive).
* The subject has a clearly identified and reliable caregiver who meets the following criteria: able to independently read and understand relevant study documents at the study site and communicate necessary information with the investigator; willing to comply with clinical study procedures and ensure the provision of accurate information regarding the subject's status throughout the study; resides with…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.