72 Participants Needed

TML-6 for Alzheimer’s Disease

CH
CT
Overseen ByClare Ting-Yi Hou
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Merry Life Biomedical Co., Ltd.

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?

TML-6 is unique because it may involve targeting the TREML2 gene, which is associated with Alzheimer's disease risk and neurodegeneration, potentially offering a novel approach compared to existing treatments that focus on amyloid plaques or tau proteins.12345

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

Subjects who are deemed to be in satisfactory health by the investigator through an assessment of their medical history, physical examinations, and routine laboratory tests.
I am a healthy volunteer.
I am of child-bearing age and my pregnancy tests are negative.
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Exclusion Criteria

I am not pregnant or breastfeeding.
Subjects had a history of substance use disorders according to the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-V) criteria.
Subjects with underlying medical, mental, or psychological conditions that may impede study compliance, or, at the discretion of the investigator, preclude participation in the study.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single-ascending Dose (SAD)

5 cohorts of subjects are planned to be orally dosed, ranging from 100 mg - 1000 mg

3 days per cohort
Multiple visits for dosing and safety assessments

Food Effect

Subjects from Cohort 2 of Part 1 receive the same dose under fed and fasting conditions

48 hours
Visits for dosing and PK sampling

Multiple-ascending Dose (MAD)

2 cohorts of subjects are dosed once daily for 7 consecutive days, ranging from 400 mg - 800 mg

7 days
Daily visits for dosing and PK sampling

Elderly Cohort

One cohort of elderly subjects receives a single dose of IP within the safe range defined in the SAD study

3 days
Visits for dosing and safety assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 days
Safety assessments post-dose

What Are the Treatments Tested in This Trial?

Interventions

  • TML-6
Trial Overview The study is testing TML-6, a potential treatment for Alzheimer's. It will look at how people handle different doses, how food affects it, and what happens to TML-6 in the body over time compared to a placebo.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TML-6 GranulesExperimental Treatment1 Intervention
This study consists of 5 parts, Part 1 (SAD): 5 cohorts of subjects are planned to be orally dosed, ranging from 100 mg - 1000 mg. Part 2 (Food effect): All subjects in Cohort 2 of Part 1 will constitute Period 1 of Part 2 and will move to Period 2 to receive the same Investigational Product (IP) dose as in Period 1. Part 3 (Elderly): One cohort of elderly subjects will receive a single dose of IP. A dose level of IP within the safe range defined in the Part 1 SAD study will be chosen Part 4 (MAD): 2 cohorts of subjects are planned to be orally dosed once daily for 7 consecutive days, ranging from 400 mg - 800 mg. Part 5 (MAD+Cerebrospinal Fluid, CSF PK): One cohort of elderly subjects will receive orally once daily for 7 consecutive days of IP. The dose level of IP defined in the Part 4 MAD study will be chosen.
Group II: PlaceboPlacebo Group1 Intervention
Placebo

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merry Life Biomedical Co., Ltd.

Lead Sponsor

Trials
1
Recruited
70+

Published Research Related to This Trial

The study identified that using the Functional Activities Questionnaire and the Clinical Dementia Rating Sum of Boxes as endpoints can detect significant changes in Alzheimer's disease progression, particularly in patients with Late Mild Cognitive Impairment, suggesting these measures are effective for future trials.
Composite measures showed even greater sensitivity, indicating that using a combination of endpoints could enhance the success rate of Alzheimer's clinical trials by better capturing the disease's progression.
The importance of endpoint selection: How effective does a drug need to be for success in a clinical trial of a possible Alzheimer's disease treatment?Evans, S., McRae-McKee, K., Wong, MM., et al.[2019]
Early diagnosis of Alzheimer's disease is crucial for initiating treatment with cholinesterase inhibitors, which can help stabilize or reduce cognitive and functional decline in patients with mild-to-moderate Alzheimer's disease.
Cholinesterase inhibitors like rivastigmine, donepezil, and galantamine are recommended as first-line therapies, while memantine can be used alone or with these inhibitors for moderate to severe cases, emphasizing the importance of tailored pharmacologic management based on disease stage.
Effective pharmacologic management of Alzheimer's disease.Farlow, MR., Cummings, JL.[2022]
In the TRAILBLAZER-ALZ study, treatment with donanemab, an amyloid-lowering drug, significantly delayed disease progression in Alzheimer's disease by approximately 5.3 months according to the Integrated Alzheimer's Disease Rating Scale and 5.2 months according to the Clinical Dementia Rating Sum of Boxes.
Expressing treatment effects as 'months saved' provides a clearer understanding of the clinical relevance of donanemab's efficacy compared to traditional metrics, making it easier for patients and clinicians to interpret the benefits of the therapy.
'Time Saved' As a Demonstration of Clinical Meaningfulness and Illustrated Using the Donanemab TRAILBLAZER-ALZ Study Findings.Dickson, SP., Wessels, AM., Dowsett, SA., et al.[2023]

Citations

The importance of endpoint selection: How effective does a drug need to be for success in a clinical trial of a possible Alzheimer's disease treatment? [2019]
Effective pharmacologic management of Alzheimer's disease. [2022]
'Time Saved' As a Demonstration of Clinical Meaningfulness and Illustrated Using the Donanemab TRAILBLAZER-ALZ Study Findings. [2023]
Pharmacotherapy of Alzheimer's disease: is there a need to redefine treatment success? [2022]
Clinical efficacy and safety of donepezil on cognitive and global function in patients with Alzheimer's disease. A 24-week, multicenter, double-blind, placebo-controlled study in Japan. E2020 Study Group. [2018]
TREML2 Mutation Mediate Alzheimer's Disease Risk by Altering Neuronal Degeneration. [2020]
Common Variant in TREM1 Influencing Brain Amyloid Deposition in Mild Cognitive Impairment and Alzheimer's Disease. [2022]
The Role of TREML2 in Alzheimer's Disease. [2021]
"New Old Pathologies": AD, PART, and Cerebral Age-Related TDP-43 With Sclerosis (CARTS). [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Anti-human TREM2 induces microglia proliferation and reduces pathology in an Alzheimer's disease model. [2021]
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