NCT05908695 An Efficacy and Safety Study of Sodium Oligomannate (GV-971) for the Treatment of Alzheimer's Disease
| NCT ID | NCT05908695 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Green Valley (Shanghai) Pharmaceuticals Co., Ltd. |
| Condition | Alzheimer's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,312 participants |
| Start Date | 2023-08-31 |
| Primary Completion | 2029-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,312 participants in total. It began in 2023-08-31 with a primary completion date of 2029-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary purpose of this study is to confirm the clinical efficacy and mechanism of action of GV-971, and identify incidence of known adverse reactions in long-term use and observe new adverse reactions, providing more guidance for clinical use.
Eligibility Criteria
Inclusion Criteria: * Mild to moderate AD per NIA-AA. * History of cognitive and functional decline over at least 1 year. * MMSE scores between 11 and 24 (inclusive) at baseline. * Hachinski Ischemic Score (HIS) scale total score ≤ 4. * Hamilton Rating Scale for Depression/17 items (HAMD) total score ≤ 10. * Brain MRI scan show the highest possibility of AD. * Have a reliable study partner/caregiver. * Sign the informed consent form. Exclusion Criteria: * Diagnosis of a dementia-related central nervous system disease other than AD. * Major structural brain disease as judged by MRI. * A resting heart rate of \< 50 beats per minute (bpm) after 10 minutes of rest. * Major medical illness or unstable medical condition within 12 months of screening. * Concomitant use of donepezil, rivastigmine, galanthamine, huperzine A, memantine, or aducanumab within 6 moinths prior to baseline. * Inadequate hepatic function. * Inadequate organ function. * ECG clinically significant abnormalities.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05908695 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 85 Years, studying Alzheimer's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05908695 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05908695 currently recruiting?
Yes, NCT05908695 is actively recruiting participants. Contact the research team at xinxianliang@greenvalleypharma.com for enrollment information.
Where is the NCT05908695 trial being conducted?
This trial is being conducted at Huainan, China, Beijing, China, Beijing, China, Beijing, China and 11 additional locations.
Who is sponsoring the NCT05908695 clinical trial?
NCT05908695 is sponsored by Green Valley (Shanghai) Pharmaceuticals Co., Ltd.. The trial plans to enroll 1,312 participants.
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