New injection aims to tackle Alzheimer's at its roots
NCT ID NCT07221344
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
This study tests a new drug called ARO-MAPT-SC in healthy people and those with early Alzheimer's. The goal is to check if it is safe and how the body processes it. Participants receive either the drug or a placebo by injection under the skin. The trial is still in early stages, so it focuses on safety and dosing, not yet on curing the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ARO-MAPT-SC (a drug given by injection under the skin)
- What this could lead to
- If successful, this could point toward a treatment that slows or stops early Alzheimer's disease by targeting a key protein in the brain.
- What could go wrong
- This is an early-phase trial with only 112 participants, so safety and effectiveness are not yet proven. The drug may cause side effects or fail to show benefit.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 112 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Nov 2025
- Expected to finish
-
Jun 2027
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 80 years
- Sex
-
Anyone
- Healthy volunteers
-
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.
Inclusion Criteria (All Participants): * Body mass index between 18.0 and 35.0 kilograms (kg)/square meter (m\^2) at Screening * Not pregnant or breast-feeding * Able and willing to provide written informed consent prior to the performance of any study specific procedures * Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later; participants must not donate sperm or eggs during the study and for at least 90 days following the end of the study or last dose of study drug whichever is later Inclusion Criteria (Alzheimer's Disease): * Adults aged 50 to 80 years of age with a clinical diagnosis of early AD and plasma, CSF, or imaging biomarkers consistent with the diagnosis * If participant is on non-disease-modifying AD medications, the doses must be stable for ≥weeks prior to Screening. 1. Participants with early AD are not required to be on AD medications. 2. Participants previously treated or currently receiving anti-amyloid therapies, including lecanemab and donanemab, are not eligible. * Have a reliable and competent caregiver or trial partner who is ≥18 years of age, able and willing to accompany the participant to study visits involving informant-based assessments, to be available to site staff by telephone as needed, and in the opinion of the Investigator, be sufficiently familiar with the participant throughout the study in order to provide accurate and reliable information relevant to study outcome measures Exclusion Criteria (All Participants): * Blood pressure outside of specified range in the protocol * Human immunodeficiency virus (HIV) infection (seropositive at Screening) * Seropositive for hepatitis B (HBV) or hepatitis C (HCV) at Screening * Intellectual disability or significant behavioral neuropsychiatric manifestation * Clinically significant cardiac, liver, or renal disease * Any contraindications to lumbar puncture * Known allergy or possible allergy to either ARO-MAPT-SC or to its excipients Note: Additional inclusion/exclusion criteria may apply per protocol.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Alzheimer disease are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
4 sites in 2 countries. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Research Site 1
RECRUITINGGrafton, Auckland, 1010, New Zealand
-
Research Site 2
RECRUITINGToronto, Ontario, M3B2S7, Canada
-
Research Site 3
RECRUITINGEast York, Ontario, M4G 3E8, Canada
-
Research Site 4
RECRUITINGMontreal, Quebec, H3G 1H9, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a massive data registry crack the code of Parkinson's and related brain diseases?
- Can a gentle electric current calm the mind in Alzheimer's?
- Alzheimer's vaccine aims to clear amyloid before memory fades
- Blood, eye, and brain scans team up to spot Alzheimer's earlier
- Can a home device slow Alzheimer's? pilot study tests pulsed electromagnetic therapy
- Eye scans as a window to the body: study probes retinal imaging across diseases