RecruitingAlzheimer's Disease
An Efficacy and Safety Study of Sodium Oligomannate (GV-971) for the Treatment of Alzheimer's Disease
Eligible age
50–85 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Source: ClinicalTrials.gov · NCT05908695 · last updated 2023-11-09