Sodium Oligomannate for Alzheimer's Disease

(GREEN MEMORY Trial)

Not currently recruiting at 251 trial locations

Overseen By Medical Director, Ph D

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Shanghai Greenvalley Pharmaceutical Co., Ltd.

Must not be taking: AChEIs, Memantine

Disqualifiers: Other dementia, Major brain disease, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called GV-971 for individuals with mild to moderate Alzheimer's disease. The goal is to determine if GV-971 is safe and effective in slowing symptoms such as memory loss and cognitive decline. Participants will receive either GV-971 or a placebo (a substance with no active medication). Those who have experienced noticeable memory and thinking problems for over a year and have a partner or caregiver to assist may be a good fit. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial requires that you stop taking AChEIs (medications for Alzheimer's) and memantine at least 30 days before starting the study and during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that GV-971, also known as sodium oligomannate, is generally safe and well-tolerated. Studies found that healthy volunteers tolerated doses of up to 1500 mg per day without problems. Trials with Alzheimer's patients revealed no unexpected safety issues. However, any treatment can have side effects, and individual experiences may vary. Consulting a healthcare professional is important when considering participation in a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Alzheimer's disease?

Unlike the standard Alzheimer's treatments that often focus on managing symptoms or temporarily boosting cognitive function, GV-971 offers a fresh approach by targeting inflammation in the brain. This treatment is derived from marine algae and works by modulating the gut microbiota to reduce neuroinflammation, which is a key contributor to Alzheimer's progression. Researchers are excited because this novel mechanism could potentially slow down the disease itself, offering hope for more than just symptom relief.

What evidence suggests that GV-971 might be an effective treatment for Alzheimer's?

Research suggests that GV-971, which participants in this trial may receive, might help people with mild to moderate Alzheimer's disease. One study showed that it slows down issues with brain energy use, often seen in Alzheimer's. Another analysis found that GV-971's benefits are similar to those of donepezil, a common Alzheimer's treatment. Further assessments show GV-971 can improve scores on memory and thinking tests like the ADAS-cog. Overall, these studies provide promising evidence that GV-971 could effectively treat Alzheimer's disease. ^{2 3 6 7 8}

Who Is on the Research Team?

Study Director, Ph D

Principal Investigator

Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

Are You a Good Fit for This Trial?

Inclusion Criteria

NIA-AA defines mild to moderate AD as those patients with an MMSE score of 20 to 26.

The person has had a cognitive and functional decline over the course of at least one year.

The brain MRI scan reveals the highest chance of developing Alzheimer's disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive GV-971 or placebo for the treatment of mild to moderate Alzheimer's disease

52 weeks

Regular visits for assessments and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term to assess efficacy of GV-971

26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GV-971
• Placebo

How Is the Trial Designed?

Group I: GV-971 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Shanghai Greenvalley Pharmaceutical Co., Ltd.

Lead Sponsor

Trials

8

Recruited

36,300+

Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

Lead Sponsor

Trials

4

Recruited

6,700+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7489025/

A phase II randomized trial of sodium oligomannate in ... F-FDG-PET data showed that treatment with GV-971 at 900 mg/day slowed the impairment of cerebral glucose metabolism in several AD-associated brain regions.

2. neurology.org neurology.org/doi/10.1212/WNL.0000000000205757

Sodium Oligomannate (GV-971) Safety and Efficacy in the ... In terms of efficacy, GV-971 is shown to be similarly beneficial in treating Alzheimer's disease as donepezil. This meta-analysis supports the ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0306452224006110

Comparison of the efficacy of updated drugs for ... SUCRA values showed that GV-971 (76.1 % and 68.7 %) could achieve better therapeutic effects in ADAS-cog) and NPI, and Lecanema (98.1 %) was more effective in ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02293915

An Efficacy and Safety Study of Sodium Oligo-mannurarate ... The primary purpose of this study is to determine the efficacy and safety of Sodium Oligo-mannurarate (GV-971) in 36-week treatment of mild to moderate ...

5. ejnpn.springeropen.com ejnpn.springeropen.com/articles/10.1186/s41983-023-00682-y

Safety and efficacy of sodium oligomannate in patients with ... We aim to evaluate the efficacy and safety of a new marine oligosaccharide drug, sodium oligomannate (GV-971), developed in China to treat Alzheimer's disease ...

6. alzdiscovery.org alzdiscovery.org/uploads/cognitive_vitality_media/Sodium_Oligomannate_(GV-971).pdf

Sodium Oligomannate (GV-971) In addition, these reports include evaluation of safety data, from clinical trials if available, and from preclinical models. Sodium Oligomannate (GV-971).

7. greenvalleypharma.com greenvalleypharma.com/En/Index/pageView/catid/48/id/39.html

Announcement on Early Termination of GV-971 Global ... On 21 January 2022, the third-party Data and Safety Monitoring Board (DSMB) analyzed the safety data of GV-971 global phase III trial when the enrollment ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05058040

NCT05058040 | A Clinical Study to Evaluate the Long- ... Phase I clinical study shows GV-971 was safe and tolerated in healthy adult volunteers when administered continuously at 1200 mg/dose or 1500 mg/day (750 mg/ ...