An Efficacy and Safety Study of Sodium Oligomannate (GV-971) for the Treatment of Alzheimer's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GV-971, Placebo.
- Who it may be relevant to
- Registry conditions: Alzheimer's Disease. Basic parameters: 50 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug GV-971
Administered PO - Drug Placebo
Administered PO
Primary outcome measures
- Change from baseline in the ADAS-cog/12 score [Time frame: Baseline, 36 weeks]
- Change from baseline in ADCS-ADL23 score [Time frame: Baseline, 36 weeks]
Secondary outcome measures (4)
- Change from baseline in MMSE score [Time frame: Baseline, 36 weeks]
- Change from baseline in the CIBIC-Plus score [Time frame: Baseline, 36 weeks]
- Change from baseline in NPI score [Time frame: Baseline, 36 weeks]
- Change from baseline in ADCS-ADL23 score [Time frame: Baseline, 36 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 50 centers
- Huainan First People's Hospital — Huainan
- Beijing Anding Hospital, Capital Medical University — Beijing
- Beijing Anzhen Hospital, Capital Medical University — Beijing
- Beijing Hospital — Beijing
- Beijing Tongren Hospital, Capital Medical University — Beijing
- Peking University Shougang Hospital — Beijing
- The First Medical Center, Chinese PLA General Hospital — Beijing
- Xuanwu Hospital, Capital Medical University — Beijing
- … and 42 more centers
Identifiers
NCT: NCT05908695 · GV-971-PoCT