Alzheimer Disease
Conditions
Brief summary
Sodium Oligomannate Capsules (GV-971) has been approved for treatment of mild to moderate Alzheimer's disease and improving the cognitive function of patients. This study plans to observe, in the clinical patients, the long-term efficacy and safety of GV-971, as well as the changes in blood and gut microbiota biomarkers after treatment, to validate the mechanism of action of GV-971, in order to better guide the rational use of drug in clinical practice.
Interventions
DRUGSodium Oligomannate Capsules (GV-971)
Sodium Oligomannate Capsules, each capsule contains 150 mg of sodium oligomannate. The recommended treatment is oral administration, 450 mg (3 capsules) per dose, bid, in morning and evening.
Sponsors
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 50 to 85 years (inclusive), with no restriction on gender; 2. Patients who met criteria for probable AD by National Institute on Aging and Alzheimer's Association (NIA-AA) diagnostic criteria; 3. Patients with mild to moderate AD as characterized by Mini-Mental State Examination (MMSE) scores between 11 and 26, inclusive; 4. Patients who have received at least primary education and have capacity to complete the measurement of cognition and other tests as specified in the protocol; 5. Patients receiving GV-971 treatment prescribed by clinicians; 6. Sign the informed consent form.
Exclusion criteria
1. Patients who have received GV-971 treatment within 6 months prior to screening; 2. Patients who may be allergic to Sodium Oligomannate Capsules as judged by the investigator; 3. Female participants who are pregnant or lactating; 4. Patients who cannot cooperate to complete the follow-up inquiries; 5. Any other diseases or conditions that are inappropriate to participate in this clinical trial in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the ADAS-cog/11 score | Baseline, 48 weeks | Change from baseline in Alzheimer's Disease Assessments Scale - cognitive (ADAS-cog/11) scale total score. The total score of ADAS-cog/11 is 0-70, with higher scores mean a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in ADAS-Cog/11 score | Baseline, 96 weeks | Change from baseline in Alzheimer's Disease Assessments Scale - cognitive (ADAS-cog/11) scale total score. The total score of ADAS-cog/11 is 0-70, with higher scores mean a worse outcome. |
| Change from baseline in MMSE score | Baseline, 48 weeks, 96 weeks | Change from baseline in Mini Mental State Examination (MMSE) score. The total score of MMSE is 0-30, with higher scores mean a better outcome. |
| Change from baseline in ADCS-ADL score | Baseline, 48 weeks, 96 weeks | Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living; 23-item Scale (ACDS-ADL23) score. The total score of ADCS-ADL23 is 0-78, with higher scores mean a better outcome. |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 48 weeks, 96 weeks | The incidence of adverse events and adverse reactions of vital signs, laboratory tests, electrocardiogram, and early withdrawal from the study in patients treated with GV-971. |
Countries
China
Outcome results
None listed