RecruitingPhase 4NCT05908695
An Efficacy and Safety Study of Sodium Oligomannate (GV-971) for the Treatment of Alzheimer's Disease
A 36-week, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of Sodium Oligomannate (GV-971) in Treatment of Mild to Moderate Alzheimer's Disease
Sponsor
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
Enrollment
1,312 participants
Start Date
Aug 31, 2023
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 50 YearsMax Age: 85 Years
Inclusion Criteria8
- 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 Criteria8
- 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.
Interventions
DRUGGV-971
Administered PO
DRUGPlacebo
Administered PO
Locations(50)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05908695
Related Trials
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
NCT071696301 location
Lombard Cohort of Brain Health Services
NCT074571385 locations
Precision Medicine and Neurodegenerative Diseases: Advanced Systems for the Diagnosis and Treatment of Parkinson's Disease and Alzheimer's Disease.
NCT074674601 location
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants With Early Symptomatic Alzheimer's Disease (eAD)
NCT072349422 locations
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease
NCT06976216111 locations