Study to Evaluate the Safety and Efficacy of AstroStem in Treatment of Alzheimer's Disease
Status:
Not yet recruiting
Trial end date:
2023-12-20
Target enrollment:
Participant gender:
Summary
This is a phase 2b randomized, double-blind, active-controlled study with 2 treatment arms,
to compare the efficacy and safety of AstroStem vs. Donepezil treatment in patients with mild
Alzheimer's Disease(AD). Eligible patients diagnosed with AD within one year of the start of
treatment will be enrolled. Patients who are randomized into the treatment group will be
administered via intravenously AstroStem and Donepezil Placebo every 4 weeks from Week 0 to
Week 16. On the other hand, patients who are randomized into the active control group will
receive 5 mg of Donepezil and AstroStem Placebo every 4 weeks from Week 0 to Week 16. After
the final administration, patients will be scheduled for two follow-up visits, at Weeks 28
and 40, to assess efficacy and safety endpoints.