RecruitingPHASE1INTERVENTIONAL

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL921 in Healthy Participants and Participants With Alzheimer's Disease

This study is testing a new potential medicine called DNL921 for Alzheimer's disease. It's an early-stage study, meaning it's one of the first times this medicine is being tested in humans. The main goals are to check if DNL921 is safe, how well people tolerate it, and how their bodies process the medicine. They also want to see what effects it has on the body. Researchers are giving DNL921 to both healthy volunteers and people with mild to moderate Alzheimer's. Some people will get the active medicine, while others will receive a dummy medicine (placebo). The information gathered will help decide if and how to continue studying DNL921 in the future.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Denali Therapeutics Inc.

Enrolment target

178

Start

07 Aug 2026

Estimated completion

01 Apr 2030

Alzheimer's Disease Healthy Participants

What is this study about?

This research study is about a new investigational medicine, DNL921, which could potentially help people with Alzheimer's disease. At this early stage (called Phase 1), the main focus is on understanding the medicine better, rather than seeing if it cures the disease. Researchers are particularly interested in two things: first, is DNL921 safe for people to take, and does it cause any side effects? Second, how does the body handle DNL921 – how does it absorb it, break it down, and get rid of it? They also want to see if DNL921 has any measurable effects on the body.

To find this out, the study involves two groups of people: healthy volunteers and people who have been diagnosed with early stages of Alzheimer's disease. Some participants will receive the active medicine, DNL921, while others will get a 'placebo' – a substance that looks exactly like the medicine but contains no active drug. This helps researchers fairly compare the effects of DNL921.

The information collected during this study is really important. It will help the researchers decide the best amount of the medicine to give and will guide future studies if DNL921 shows promise. It's a key step in developing new treatments for Alzheimer's.

Key takeaways

This is an early-stage study testing a new medicine (DNL921) for Alzheimer's disease.
The main goals are to check the medicine's safety and how the body handles it.
The study involves both healthy volunteers and people with early Alzheimer's.
Some participants will receive the active medicine, others a dummy medicine (placebo).
You will receive close medical monitoring if you take part.
You can withdraw from the study at any time without affecting your normal care.

Who may be eligible?

To be considered for this study, you would generally need to be between 18 and 75 years old. The study is looking for two groups of people: healthy volunteers and people who have been diagnosed with mild to moderate Alzheimer's disease. Both men and women can take part. Women must not be able to get pregnant (for example, if they've gone through menopause or had a hysterectomy).

If you're a healthy volunteer, you'll generally need to be aged 18 to 60. If you have Alzheimer's, you'll typically need to be aged 50 to 75. For both groups, your weight and height would need to be within a certain range. For those with Alzheimer's, doctors would need to confirm your diagnosis and show signs of the disease in your body, for example, through special blood tests or scans.

There are also reasons why you might not be able to join. For example, if you have other serious medical conditions like heart, lung, or kidney problems, or certain mental health issues, you might not be suitable. Women who are pregnant or breastfeeding cannot participate. The study team will review your full medical history carefully to make sure it's safe for you to take part.

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?
If you are a woman, are you unable to get pregnant?
Do you have a diagnosis of mild to moderate Alzheimer's, or are you a healthy adult?
Are you generally in good health, without other serious medical conditions?
Are you comfortable with regular hospital visits and health checks?
Are you prepared to potentially receive a dummy medicine (placebo)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit. This involves health checks, blood tests, and other assessments to ensure you meet the study's requirements.

After screening, you would receive either the new medicine (DNL921) or a dummy medicine (placebo). You wouldn't know which one you're getting. You would have several visits to the clinic or hospital, where doctors and nurses would monitor your health, check for any side effects, and take samples (like blood) to see how the medicine is affecting your body. These visits will be spread out over a period, and the team will explain the full schedule to you.

Throughout the study, you'd be asked to follow specific instructions about your diet, other medicines you might be taking, and your daily activities. There will also be follow-up appointments after you stop taking the study medicine to make sure you're well. The total duration of your involvement, including all visits and follow-ups, would be fully explained before you agree to join.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might feel you are contributing to medical research and helping others in the future, especially those with Alzheimer's disease. You would also receive close medical attention and monitoring from the study team. However, it's important to remember that DNL921 is an investigational medicine, and we don't yet know if it will be effective or if it has side effects. There's a chance you might experience side effects, some of which could be unexpected or serious. You can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

Common questions

What is a 'Phase 1' study?

Phase 1 means this is an early study, primarily focused on checking if the new medicine is safe for people to take and understanding how the body handles it. It's not mainly about whether it cures a disease yet.

What is a 'placebo'?

A placebo is a dummy medicine that looks exactly like the real medicine but contains no active drug. It helps researchers compare the effects of the active medicine fairly.

Who can take part in this study?

This study is looking for healthy volunteers aged 18-60 and people diagnosed with mild to moderate Alzheimer's disease aged 50-75. Both men and women can participate, but women must not be able to get pregnant.

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

No, this is a 'blinded' study, meaning neither you nor the study team will know whether you are receiving DNL921 or the placebo. This helps ensure the results are unbiased.

What does 'non-childbearing potential' mean for women?

It means you are unable to become pregnant. This could be because you've gone through menopause, had a hysterectomy, or other specific reasons. The study team will confirm this.

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.