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Can a new drug tame Alzheimer's? early trial aims to find out

NCT ID NCT07758595

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This early-stage trial is testing an experimental drug called DNL921 to see if it is safe and tolerable for people. It will involve healthy volunteers and people with Alzheimer's disease, who will receive either the drug or a placebo. The main goal is to gather safety data and understand how the drug moves through the body, which will help plan future, larger studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DNL921, an experimental drug being tested as a potential treatment for Alzheimer's disease
What this could lead to
If successful, this early trial could pave the way for a new treatment that slows or alters the course of Alzheimer's disease.
What could go wrong
This is a very early (Phase 1) study focused on safety and dosing, not effectiveness. The drug may not work or could have side effects, and much more research is needed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 178 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Apr 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria (Healthy Participants): * Are male or female of non-childbearing potential and are aged 18 through 60 years at the time of screening * Have a BMI of 18 through 32 kg/m2 and a body weight of at least 50 kg * For female participants: Are of non-childbearing potential * For male participants: Are surgically sterile by bilateral orchidectomy, or are abstinent, or agree to use two acceptable forms of contraception Key Exclusion Criteria (Healthy Participants): * Have any history of clinically significant neurological, psychiatric, endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematological, immunological, or allergic disease, or other major disorders * Have a positive serum pregnancy test or are currently lactating or breastfeeding * Have been hospitalized during the 4 weeks prior to screening Key Inclusion Criteria (Participants with AD): * Are male or female of non-childbearing potential and aged 50 to 75 years at the time of screening * Have a BMI between 18 and 32 kg/m2 and a body weight of at least 45 kg * Have a diagnosis of probable mild to moderate AD dementia based on NIA AA 2011 criteria, including amnestic or nonamnestic presentation at screening or prodromal AD (consistent with the NIA-AA diagnostic criteria and guidelines for mild cognitive impairment due to AD) * Have supportive evidence of AD pathology by the following: * Plasma ptau217/Abeta42 positive * Positive amyloid PET scan * For female participants: Are of non-childbearing potential * For male participants: Are surgically sterile by bilateral orchidectomy, or are abstinent, or agree to use two acceptable forms of contraception Key Exclusion Criteria (Participants with AD): * Have other clinically significant neurological or cognitive disorders affecting the CNS, as determined by the investigator, other than AD * Have specific psychiatric conditions * Have any history of unstable or poorly controlled endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, hematological, or other significant medical condition that, in the opinion of the investigator, may interfere with the completion or interpretation of study assessment * Have had a malignancy within 5 years before screening, except fully resected basal cell carcinoma or other malignancies treated with curative intent (such as prostate cancer) at low risk of recurrence * Have a positive serum pregnancy test or are currently lactating or breastfeeding * Have been hospitalized during the 4 weeks prior to screening * Have had previous anti-amyloid or anti-tau immunotherapy (including active immunization) or have participated in experimental gene therapy or cell therapy at any time

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clinical Site(s)

    RECRUITING

    Manchester, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.