RecruitingPHASE1INTERVENTIONAL

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease

This Phase 1 study is looking into a new medication called DNL628 for individuals in the early stages of Alzheimer's disease, including those with mild memory problems or mild Alzheimer's. The main goals are to understand if the drug is safe and well-tolerated, how the body processes it, and what effects it might have. This is a "blinded" study, meaning neither the participants nor the doctors will know who is receiving DNL628 and who is getting a placebo (a dummy drug). Participants will take a dose of the medication, which will be gradually increased, over time. This helps researchers carefully monitor safety and gather important information about its potential. Researchers are particularly interested in people who show signs of Alzheimer's proteins in their brain.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Denali Therapeutics Inc.

Enrolment target

Start

30 Jan 2026

Estimated completion

01 Feb 2027

Alzheimer Disease, Early Onset

What is this study about?

This research is investigating a new medication called DNL628, which is in the early stages of development. It's specifically for people who have been diagnosed with early Alzheimer's disease. "Early Alzheimer's" here means having mild memory or thinking problems, or a mild form of Alzheimer's itself, where there's also evidence of particular protein changes in the brain linked to the condition.

The main purpose of this study is to find out if DNL628 is safe for people to take and how well their bodies tolerate it. Researchers will also be looking at how the body absorbs, distributes, metabolises, and gets rid of the drug, and what effects it might have on the body. This kind of early-stage study is crucial for learning about new potential treatments before they can be tested more widely.

Participants will be placed into groups that receive different dosages of DNL628, or a placebo, which looks like the drug but contains no active medicine. This is a "blinded" study, so neither you nor your doctor will know which you are receiving. This is a standard way to make sure the study results are as unbiased as possible. The information gathered from this study will help determine if DNL628 could be a promising treatment for Alzheimer's and if it should be studied further.

Key takeaways

Tests a new drug (DNL628) for early Alzheimer's disease.
Aims to check safety, how the body handles the drug, and its effects.
Some participants will receive a placebo (dummy drug).
Open to individuals aged 18-75 with mild Alzheimer's symptoms and specific brain changes.
Participation involves regular clinic visits and various assessments.
Results could help develop future Alzheimer's treatments.

Who may be eligible?

To join this study, people generally need to be between 18 and 75 years old and have a confirmed diagnosis of probable Alzheimer's disease. This diagnosis needs to be supported by evidence of specific Alzheimer's-related proteins in the brain. Their Alzheimer's symptoms should be mild, as measured by certain medical scores that assess thinking and memory.

There are also some reasons why someone might not be able to join. For example, if they have other significant brain conditions apart from Alzheimer's, or serious mental health problems. People with uncontrolled chronic health conditions, a recent history of cancer, or those who have had certain previous treatments for Alzheimer's (like specific anti-amyloid or anti-tau immunotherapy, or gene therapy) would also not be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 75 years old?
Have you been diagnosed with probable early Alzheimer's disease?
Do you have evidence of Alzheimer's proteins in your brain?
Are your Alzheimer's symptoms currently mild?
Do you have any other significant brain conditions?
Have you had certain previous treatments for Alzheimer's?

Answer every question to see your result.

What does participation involve?

If you decide to participate, you will regularly visit the clinic, where doctors and nurses will monitor your health and how you respond to the study medication. You will receive either DNL628 or a placebo, and the dose may be gradually increased over time. Assessments will include various tests to check your memory and thinking, blood tests, and possibly brain scans to help researchers understand the drug's effects. You may need to come to the clinic for several appointments over the study period. The exact duration and number of visits would be fully explained before you agree to take part.

Potential risks and benefits

Participating in research always comes with potential benefits and risks. You might not directly benefit from taking the study drug, as it's an early-stage investigation, and some participants will receive a placebo. However, your participation could help researchers learn more about Alzheimer's disease and contribute to the development of future treatments, which could benefit others. Potential risks include side effects from the medication or discomfort from tests, which would be fully explained to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Clinical Site(s)
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is a 'placebo'?

A placebo is a substance that looks like the study drug but doesn't contain any active medicine. It helps researchers compare the effects of the active drug.

What does 'early Alzheimer's disease' mean in this study?

In this study, it refers to people with mild memory problems (mild cognitive impairment) or mild Alzheimer's disease, with evidence of Alzheimer's-related proteins in their brain.

Will I know if I'm getting the real drug or the placebo?

No, this is a 'blinded' study, meaning neither you nor your study doctor will know whether you are receiving DNL628 or the placebo until the study is over.

How long will I need to be in the study?

The information provided doesn't specify the exact duration, but the full details would be discussed with you before you decide to join.

Can I stop participating in the study at any time?

Yes, you have the right to withdraw from the study at any point, and your decision will not affect your regular medical care.

How to find out more

Clinical Trials at Denali Therapeutics

clinical-trials@dnli.com Email: Official trial record

Always speak to your GP or specialist before deciding to take part in a study.