A Study of Sodium Oligomannate (GV-971) in Participants With Mild to Moderate Alzheimer's Disease

(GREEN MEMORY Trial)

Recruiting at 239 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

2046 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

This trial is testing a new drug called GV-971 to see if it is safe and effective for people with mild to moderate Alzheimer's disease. The drug aims to help by reducing inflammation in the brain and clearing out harmful proteins. Researchers hope this will slow down the progression of Alzheimer's symptoms.

Research Team

Study Director, Ph D

Principal Investigator

Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

Eligibility Criteria

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

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

Treatment Details

Interventions

• GV-971
• Placebo

Participant Groups

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+