Can a new drug tame Alzheimer's? early trial aims to find out
NCT ID NCT07758595
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 178 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Apr 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Clinical Site(s)
RECRUITINGManchester, United Kingdom
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