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A Phase 2 Study of TML-6 in Adults with Early Alzheimer’s Disease to Evaluate Safety, Tolerability, and Efficacy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on Early Alzheimer’s Disease, a condition that causes gradual loss of memory and everyday abilities. The investigational medicine being examined is called TML-6, which is taken as a tablet once daily. The aim of the trial is to determine whether a year of treatment with this drug can slow, stop, or improve the decline in thinking skills and daily function compared with a placebo.

Participants are randomly assigned to receive either the study drug at two possible doses or the placebo, and neither the participants nor the study staff know which treatment is given. Over 52 weeks, participants attend regular clinic visits where safety is checked through physical exams, vital signs, weight measurements, and questionnaires about mood. Cognitive and functional abilities are measured using the clinical dementia rating - sum of boxes, a score that reflects the severity of dementia, and the integrated Alzheimer’s disease rating scale, a test that looks at memory and daily tasks. Blood samples are taken to assess proteins linked to Alzheimer’s, such as p-Tau217 (a form of tau protein), amyloid β-protein Aβ40 and Aβ42 (building blocks of plaque), as well as markers of nerve damage (neurofilament light chain) and brain inflammation (glial fibrillary acidic protein). Brain imaging includes a size‑measuring scan called volumetric magnetic resonance imaging and a special scan that visualizes amyloid plaques known as amyloid positron emission tomography. All data are collected to evaluate whether the medication is safe and whether it helps preserve thinking and daily abilities.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study enrollment confirmed
You have been confirmed as a participant in a phase 2 study that will last for 52 weeks.
The study will compare the effects of tml-6 with a matching placebo in people with early alzheimer’s disease.
Step 2
Baseline assessments
Before starting any medication, a series of tests will be done to record your current condition.
These include cognitive and functional questionnaires, blood samples to measure specific proteins, and brain imaging scans.
The results will be used as a reference point for later comparisons.
Step 3
Randomization
After the baseline assessments, you will be randomly assigned to one of three groups:
• a group that receives a 100 mg oral tablet of tml-6 each day,
• a group that receives a 200 mg oral tablet of tml-6 each day, or
• a group that receives a matching placebo tablet each day.
The assignment is done by a computer and you will not know which group you are in.
Step 4
Start of study medication
You will begin taking the assigned tablet by mouth once daily.
The tablet should be swallowed with water and taken at the same time each day.
The medication will be continued for the full 52‑week period unless a safety concern requires stopping it.
Step 5
Regular safety checks
Throughout the 52 weeks you will attend scheduled clinic visits where staff will:
• ask about any new symptoms or side effects,
• perform routine laboratory tests on blood samples,
• measure vital signs such as blood pressure and body weight,
• conduct brief physical and neurological examinations, and
• complete a short questionnaire to assess thoughts of self‑harm (columbia suicide severity rating scale).
These checks help ensure the medication is safe for you.
Step 6
Mid‑study monitoring (optional)
If the study protocol includes intermediate visits, additional blood samples may be taken to track changes in protein markers.
No new medication changes will be made during these visits.
Step 7
Final assessments at week 52
At the end of the 52‑week treatment period you will undergo the same set of assessments performed at baseline.
These include the cognitive and functional questionnaires, blood biomarker tests, and brain imaging scans.
The results will be compared with the baseline data to determine whether tml-6 affected the progression of early alzheimer’s disease.
Step 8
Study completion
After the final assessments, the study medication will be stopped.
You will receive information about any follow‑up care that may be recommended by your regular doctor.

Who can join the trial?

4 criteria

Be a man or a post‑menopausal woman (a woman who has not had a menstrual period for at least 12 months and is not taking medicines that stop periods), aged between 60 and 85 years, and if you are a man who has sexual activity with a woman who could become pregnant, you must agree to use birth‑control methods and not donate sperm.
Have a blood test that shows elevated levels of specific proteins called p‑Tau217 or p‑Tau181 (these are blood biomarkers used to help identify early Alzheimer’s disease) that meet the study’s required cut‑off values.
Have been diagnosed by a doctor with mild cognitive impairment (MCI) due to Alzheimer’s disease (an early stage of memory problems) and meet all of the following: a) meet standard clinical criteria for MCI, b) have at least one of the required biomarker levels, c) score between 24 and 28 on the Mini Mental State Examination (a short test of thinking and memory), and d) have a Clinical Dementia Rating (CDR) Global Score of 0.5, which indicates very mild dementia.
Alternatively, have been diagnosed by a doctor with mild Alzheimer’s dementia and meet all of the following: a) meet standard clinical criteria for probable Alzheimer’s dementia, b) have at least one of the required biomarker levels, c) score between 20 and 26 on the Mini Mental State Examination, and d) have a Clinical Dementia Rating Global Score of 0.5 or 1, indicating mild dementia.

Who cannot join the trial?

12 criteria

Women who have not yet stopped having periods (not menopausal) and have not been at least one year after menopause cannot join the study.
Anyone who has previously received anti‑amyloid therapy (treatment that targets amyloid proteins) is not allowed to participate.
A blood test showing an ALT level (a liver enzyme called alanine aminotransferase) higher than the normal range excludes the person.
A blood test showing an AST level (a liver enzyme called aspartate aminotransferase) higher than the normal range excludes the person.
A blood test showing a total bilirubin level (a substance processed by the liver) higher than the normal range excludes the person.
A low absolute neutrophil count (a type of white blood cell) below 1,500 cells per microliter, unless this is the person's usual level, excludes the person.
A hemoglobin level (the protein in red blood cells that carries oxygen) below 12 g/dL excludes the person.
An estimated glomerular filtration rate (a measure of kidney function) lower than 50 mL/min/1.73 m² excludes the person.
A total cholesterol level (a type of fat in the blood) of 240 mg/dL or higher excludes the person.
A positive test for HIV (human immunodeficiency virus) excludes the person.
A positive test for hepatitis B surface antigen (HBsAg), indicating hepatitis B infection, excludes the person.
A positive test for hepatitis C virus by PCR (a DNA test) or a history of treatment for hepatitis C excludes the person.

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Verified sites

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University Of Skane
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Malmo, Sweden
Uppsala University Hospital
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Uppsala, Sweden

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Investigated drugs

TML-6 is an experimental oral tablet being studied as a possible treatment for early Alzheimer’s disease. In the trial, participants take the tablet once daily for one year. Researchers are looking to see if TML-6 can slow down, stop, or even improve the loss of memory and daily functioning that occurs with Alzheimer’s. The medication is still under investigation, so its safety and how well it works are being closely monitored throughout the study.

What is already known about the treatment

TML-6 - TML-6 is taken as an oral tablet, usually 100 mg or 200 mg once daily. It is an experimental small‑molecule drug that is still in early clinical testing and has not been approved for any use. The drug is being studied for people with early Alzheimer’s disease, aiming to slow or improve memory loss and daily function. It works by blocking the formation of harmful protein clumps in the brain and reducing inflammation, placing it in the class of neuroprotective agents.

Investigated diseases

Early Alzheimer’s disease - Early Alzheimer’s disease is a stage of Alzheimer’s disease where memory problems and mild thinking difficulties first appear. People may notice forgetting recent events, misplacing items, or having trouble finding words. As the condition progresses, these cognitive changes become more noticeable and affect daily activities such as managing finances or driving. Over time, the disease spreads to other brain areas, leading to increasing confusion, difficulty with planning, and reduced ability to perform familiar tasks. The progression is usually gradual, with symptoms worsening over several years.