TML-6 for Alzheimer’s Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to evaluate the safety, tolerability, single-ascending dose (SAD), multiple-ascending dose (MAD), food effect, and pharmacokinetic (PK) Study of TML-6.
Will I have to stop taking my current medications?
Participants must stop taking any medications (except vitamins, food supplements, and hormonal contraceptives) within 14 days before the first dose of the study drug, unless the investigator and sponsor agree that the medication won't interfere with the study or compromise safety.
How does the drug TML-6 differ from other Alzheimer's treatments?
What data supports the effectiveness of the drug TML-6 for Alzheimer's disease?
The research suggests that using expanded criteria for treatment success, cholinesterase inhibitors, which are similar to TML-6, have shown clinically meaningful long-term benefits in multiple areas for Alzheimer's patients. Additionally, donepezil, a cholinesterase inhibitor, has been effective in improving cognitive and global function in patients with mild to moderately severe Alzheimer's disease.678910
Are You a Good Fit for This Trial?
This trial is for healthy adults and elderly volunteers who are interested in helping to find new treatments for Alzheimer's disease. Participants should not have any serious health issues that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Single-ascending Dose (SAD)
5 cohorts of subjects are planned to be orally dosed, ranging from 100 mg - 1000 mg
Food Effect
Subjects from Cohort 2 of Part 1 receive the same dose under fed and fasting conditions
Multiple-ascending Dose (MAD)
2 cohorts of subjects are dosed once daily for 7 consecutive days, ranging from 400 mg - 800 mg
Elderly Cohort
One cohort of elderly subjects receives a single dose of IP within the safe range defined in the SAD study
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- TML-6
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merry Life Biomedical Co., Ltd.
Lead Sponsor