NCT05181475 · Phase 4 · ACTIVE NOT RECRUITING
Long-term Efficacy and Safety Study of GV-971
This study follows people with mild to moderate Alzheimer's who are already prescribed GV-971, a capsule taken by mouth. Researchers will track memory and thinking over time, safety, and changes in blood and gut bacteria markers. It is a Phase 4 study, meaning the drug is already approved in some places and is being watched in real-world use.
You may qualify if
- Aged 50 to 85 years (inclusive), with no restriction on gender;
- Patients who met criteria for "probable AD" by National Institute on Aging and Alzheimer's Association (NIA-AA) diagnostic criteria;
- Patients with mild to moderate AD as characterized by Mini-Mental State Examination (MMSE) scores between 11 and 26, inclusive;
- Patients who have received at least primary education and have capacity to complete the measurement of cognition and other tests as specified in the protocol;
- Patients receiving GV-971 treatment prescribed by clinicians;
- Sign the informed consent form.
You're excluded if
- Patients who have received GV-971 treatment within 6 months prior to screening;
- Patients who may be allergic to Sodium Oligomannate Capsules as judged by the investigator;
- Female participants who are pregnant or lactating;
- Patients who cannot cooperate to complete the follow-up inquiries;
- Any other diseases or conditions that are inappropriate to participate in this clinical trial in the opinion of the investigator.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2024-11-15