Testing ARO-MAPT-SC against a placebo for alzheimer disease
Official title: Study of ARO-MAPT-SC in Healthy Participants and Participants With Early Alzheimer's Disease
A Phase 1/2a Placebo-Controlled Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARO-MAPT-SC in Healthy Subjects and Subjects With Early Alzheimer's Disease
Interventions
ARO-MAPT-SC
• single or multiple doses of ARO-MAPT-SC by subcutaneous (SC) injection
Placebo
• calculated volume to match active treatment by SC administration
Canadian Sites (2)
Research Site 3
East York, Ontario, Canada
Research Site 2
Toronto, Ontario, Canada
Eligibility Criteria
See who this study is looking for28 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Adults aged 50 to 80 years of age with a clinical diagnosis of early AD and plasma, CSF, or imaging biomarkersBiomarkerSomething measurable in the body used as a signal of what is happening.Read more → consistent with the diagnosis
- +Known allergy or possible allergy to either ARO-MAPT-SC or to its excipients
- +Human immunodeficiency virus (HIV) infection (seropositive at ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →)
- +Seropositive for hepatitis B (HBV) or hepatitis C (HCV) at Screening
- +(All Participants):
- +Body mass index between 18.0 and 35.0 kilograms (kg)/square meter (m\^2) at Screening
- +Able and willing to provide written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → prior to the performance of any study specific procedures
- +Inclusion CriteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → (Alzheimer's Disease):
- +If participant is on AD medications, the doses must be stable for ≥weeks prior to Screening.
- +a. Participants with early AD are not required to be on AD medications.
- +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 siteTrial siteA hospital or clinic where a study is actually run.Read more → staff by telephone as needed, and in the opinion of the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, be sufficiently familiar with the participant throughout the study in order to provide accurate and reliable information relevant to study outcome measuresEndpointThe specific thing a study measures to answer its question.Read more →
- +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → (All Participants):
- +Blood pressure outside of specified range in the protocolProtocolThe detailed plan a study must follow.Read more →
- +Intellectual disability or significant behavioral neuropsychiatric manifestation
- +Clinically significant cardiac, liver, or renal disease
- +Any contraindications to lumbar puncture
- +Note: Additional inclusion/exclusion criteria may apply per protocol.
- +Not pregnant or breast-feeding
- +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
Exclusion
- −Known allergy or possible allergy to either ARO-MAPT-SC or to its excipients
- −Human immunodeficiency virus (HIV) infection (seropositive at ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →)
- −Seropositive for hepatitis B (HBV) or hepatitis C (HCV) at Screening
- −(All Participants):
- −Blood pressure outside of specified range in the protocolProtocolThe detailed plan a study must follow.Read more →
- −Intellectual disability or significant behavioral neuropsychiatric manifestation
- −Clinically significant cardiac, liver, or renal disease
- −Any contraindications to lumbar puncture
- −Note: Additional inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →/exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → may apply per protocol.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more →/2 — a combined study that starts with early safety and continues into what the treatment does.
What is being given or done in this study: ARO-MAPT-SC, PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 18 years to 80 years.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 112 people.
The study is currently expected to finish around June 2027.
The main measurement is taken over: Through End of Study (EOS), Day 270.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Number of Participants with Treatment-Emergent Adverse EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (TEAEs) Over Time — measured over Through End of Study (EOS), Day 270.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07221344 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About ARO-MAPT-SCDrug
• single or multiple doses of ARO-MAPT-SC by subcutaneous (SC) injection
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
• calculated volume to match active treatment by SC administration
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 80 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 80 years.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Through End of Study (EOS), Day 270.
The study as a whole is currently expected to finish around 2027-06.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 112 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: East York, Ontario, Canada; Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of ARO-MAPT-SC compared to placebo in adult healthy volunteers and in participants with early Alzheimer's disease (AD), defined as mild cognitive impairment due to AD and mild AD dementia.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.