A Study to Evaluate the Safety, Tolerability, and Efficacy of TML-6 in Participants With Early Alzheimer's Disease

Sponsor
Merry Life Biomedical Co., Ltd.
Study ID
NCT07612150
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • TML-6 — DRUG
    TML-6 tablets for oral administration.
  • Placebo — OTHER
    TML-6 matching placebo tablets for oral administration.

Study Details

The primary purpose of the study is to assess if treatment with TML-6 for 52 weeks will be effective in slowing, stopping, or improving cognitive and functional decline in participants with early Alzheimer's Disease (AD) as compared to participants receiving placebo.

Key Dates

First listed
May 28, 2026
Start date
Aug 1, 2026
Status verified
May 2026
Primary completion
Apr 30, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
210 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Participants will TML-6 matching placebo tablets, orally, once daily for up to Week 52.
  • Experimental: TML-6 100 mg
    Participants will receive TML-6 100 milligram (mg), tablet, orally, once daily for up to Week 52.
  • Experimental: TML-6 200 mg
    Participants will receive TML-6 200 mg, tablet, orally, once daily for up to Week 52.

Primary Outcome Measure

Change From Baseline in Clinical Dementia Rating -Sum of Boxes (CDR-SB) Score at Week 52 [ Time Frame: Baseline and at Week 52 ]

Central Contacts

Find similar trials

Nationwide
Alzheimer's disease trialsNeurology trialsDementia care trialsBrain disorders trialsGeriatrics trials

Related Studies