A Study to Evaluate the Safety, Tolerability, and Efficacy of TML-6 in Participants With Early Al… (NCT07612150) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study to Evaluate the Safety, Tolerability, and Efficacy of TML-6 in Participants With Early Alzheimer's Disease
210 participantsStarted 2026-08-01
Plain-language summary
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.
Who can participate
Age range
60 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male participants or post-menopausal female participants (defined as women who have not had a menstrual period for at least 12 consecutive months, without the influence of medications known to cause amenorrhea) aged 60 to 85 years (inclusive) at the time of informed consent. If the male participant is sexually active with a female partner of childbearing potential, he must be willing and able to comply with the protocol-specified contraception and reproductive risk management requirements and agree to refrain from sperm donation, in accordance with the protocol.
. Screening of blood biomarkers: local p-Tau217 or p-Tau181 should meet the National Institute of Aging - Alzheimer's Association (NIA-AA) core clinical criteria, Revised Criteria for Diagnosis and Staging of Alzheimer's Disease, 2024 Updated.
. Have a clinical diagnosis of Mild Cognitive Impairment (MCI) due to AD - intermediate likelihood (Alzheimer's Association International Conference \[AAIC\] Stage 2 to 3):
. Meet the NIA-AA core clinical criteria for MCI due to AD.
. Blood biomarkers cut-off value (any one of the following):
. Mini-Mental State Examination (MMSE) score of 24 to 28 (inclusive) at screening.
. CDR-Global Score of 0.5 at screening. OR
. Have a clinical diagnosis of mild AD dementia (Alzheimer's Association International Conference Alzheimer's Disease \[AAIC AD\] staging 4):
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Clinical Dementia Rating -Sum of Boxes (CDR-SB) Score at Week 52
. Have an identified study partner who in the opinion of the investigator, has contact with the participant for 10 hours or more per week. The study partner must provide separate written informed consent. In addition, this person must be willing and able to provide follow-up information on the participant throughout the course of the study. For study partners not residing with the participant, the investigator has to be satisfied that the participant can contact the study partner readily during the times when the study partner is not with the participant. If in doubt about whether a participant's care arrangements are suitable for inclusion, the investigator should discuss this with the medical monitor. Study partners need to participate in person for visits where clinical assessments take place.
. Be able to provide written informed consent.
0. Willing and able to comply with all aspects of the protocol.
1. Participants who received treatment or participated in a clinical trial with curcumin and ginkgo can be enrolled after 1 month of treatment discontinuation. In addition, participants who received treatment or participated in a clinical trial with noncurcumin, non-ginkgo or have been enrolled in a clinical trial for any type of cognitive treatment can only be enrolled after 3 months or 5 half-lives (whichever is longer) of treatment discontinuation.
2. Have adequate premorbid literacy, and current adequate vision, hearing, and motor skills to complete neuropsychological testing in the opinion of the investigator. Corrective aids are allowed.
. Female participants who are not yet menopausal or have not reached 1-year post-menopause are excluded.
. Any participant who has received anti-amyloid therapy.
. Any laboratory values with the following deviations at screening and admission. The laboratory test may be repeated once during the screening period.