Alzheimer's disease
Conditions
Interventions
gv-971 Group:All subjects received oral gv-971 at 900mg/ day
Sponsors
Beijing Anding Hospital affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Provide written informed consent; 2. Age 50-85 years; 3. Meet the criteria for a probable diagnosis of AD established by the National Neuropathic Speech Disorders Stroke - Alzheimer's Disease and Related Disorders Society (NINCDS-ADRDA); 4. Baseline 11 points = total MMSE score =24 points; 5. Hdrs-17 score >7 at baseline 6) Education level above primary school.
Exclusion criteria
Exclusion criteria: 1. Severe unstable physical diseases; 2. History of suicidal behavior in the past 12 months or C-SSRS suicide perception questions at screening 4 or 5 to determine current suicide risk; 3. Participated in another interventional clinical study within the past 1 month; 4. The past or at present the following mental disorders diagnosed by DSM - 5: organic mental disorders, other causes of dementia, schizophrenia, schizoaffective disorder, bipolar disorder, delusional disorders, undifferentiated patients with mental illness, has a history of substance abuse, including with alcohol, and active drug abuse in the past 12 months, except nicotine; 5. Taking medications that may affect cognition such as antihistamines, anticholinergics, and benzodiazepines in the last 2 weeks; 6. Select the patients who received electroconvulsive therapy and transcranial magnetic stimulation treatment in the first 3 months; 7. Those who have taken mannat sodium (GV-971) in the past or are allergic to GV-971; 8. Use other types of neurotropic drugs including cholinesterase inhibitors and NMDA receptor antagonists in the past 2 weeks; 9. Severe aphasia, vision and hearing impairment, etc., unable to complete the scale assessment; 10. Pregnant or breastfeeding women or those planning to become pregnant; 11. Unable to complete MRI; 12.MRI showed more than 2 lacunar infarcts, regional infarcts with a volume of more than 1cm3, and significant white matter lesions. The overall Fazekas score was 3. 13. Gastrointestinal diseases that may affect absorption; 14. Resting heart rate <50 beats/min after 10 minutes' rest; participated in other clinical studies in recent 1 month.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Change in ADAS-COG scale each factor score from baseline at the end of 36 weeks;36 weekend participants' HDRS-17 scores, total scores and sub-scores changed;36 weekend participants' HAMA scores, total scores and sub-scores changed;36 weekend participants' GDS scores, total scores and sub-scores changed;36 weekend participants' ADL scores, total scores and sub-scores changed;Differences in sleep structure among participants at 36 weeks;Differences in connectivity between different brain zones of functional MRI at 36 weeks;Changes in intestinal phages, bacteria and metabolites at 36 weeks;Changes in neuroinflammatory IL-6, IL-1ß, TNF a at 36 weeks;Treatment response rate;Treatment remission rate;the proportion of termination due to invalidity; | — |
Primary
| Measure | Time frame |
|---|---|
| Change in ADAS-COG scale total score from baseline at the end of 36 weeks; | — |
Countries
China
Contacts
Public ContactQinge Zhang
Beijing Anding Hospital affiliated to Capital Medical University
Outcome results
None listed