An Efficacy and Safety Study of Sodium Oligomannate (GV-971) for the Treatment of Alzheimer's Disease

Green Valley Pharmaceuticals

Status and phase

Enrolling

Phase 4

Conditions

Alzheimer's Disease

Treatments

Drug: Placebo

Drug: GV-971

Study type

Interventional

Funder types

Industry

Identifiers

NCT05908695

GV-971-PoCT

Details and patient eligibility

About

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.

Enrollment

1,312 estimated patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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.