Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05269173 | Efficacy and Safety of Flos Gossypii Flavonoids Tablet in the Treatment of Alzheimer's Disease | PHASE2 | COMPLETED | 240 | — | — | Oct 29, 2020 | Nov 5, 2024 | Nov 12, 2024 | 19 | China |
Differences between the low-dose and high-dose groups in changes in ADAS cog/11 scores (relative to baseline) at weeks 13 and 26 were compared with the placebo group. The ADAS-cog/11 measures 11 items: word recall, commands, constructional praxis, naming objects or fingers, ideational praxis, orientation, word recognition, remembering word recognition test instructions, spoken language ability, word-finding difficulty and comprehension. The total score ranges from 0 to 70, with lower scores representing milder disease.
| Arm | Type | Description |
|---|---|---|
| Active group(low dose group) | ACTIVE_COMPARATOR | Take 5 tablets each time (including 3 tablets of study drug and 2 tablets of placebo), 3 times a day, a total of 2.7g per day. Take it with warm water half an hour before meals. |
| Active group(high dose group) | ACTIVE_COMPARATOR | Take 5 tablets of the study drug each time, 3 times a day, a total of 4.5g per day. Take it with warm water half an hour before meals. |
| Control group | PLACEBO_COMPARATOR | Take 5 tablets of the control drug (placebo) each time, 3 times a day, 4.5g a day. Take it with warm water half an hour before meals. |
| Name | Type | Description |
|---|---|---|
| Flos gossypii flavonoids tablet | DRUG | The distribution ratio between the groups was 1:1:1, and the stratification factor was the degree of illness CDR score. In the study, the entry of each subject into the high-dose group, low-dose group or placebo group will be determined by the randomized system. |
Inclusion Criteria: 1. Age 50 to 85 years old (including 50 and 85 years old), male or female; 2. Meet the diagnostic criteria of "likely ad dementia" of the National Institute on aging Alzheimer's disease association (NIA-AA) (2011); 3. The subjects are primary school graduates / graduates and abo...