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Alzheimer DiseasePhase 1/2NCT07221344

Study of ARO-MAPT-SC in Healthy Participants and Participants With Early Alzheimer's Disease

A Phase 1/2 study testing ARO-MAPT-SC in people with Alzheimer Disease and Alzheimer Disease, Early Onset, run by Arrowhead Pharmaceuticals at 4 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
What is being tested?
ARO-MAPT-SC
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
112 participants
Where
4 sitesin 2 countries
Study dates
18 Nov 2025to Jun 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
  • 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.
Show all 9Show fewer
  • Participants with early AD are not required to be on AD medications.
  • 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

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Medical Monitor contact

626-304-3400

AROMAPT-SC-1001@arrowheadpharma.com

4 sites in 2 countries

Canada3 sites, 3 recruiting

  • Research Site 3

    East York, Ontario, M4G 3E8

    Recruiting

  • Research Site 4

    Montreal, Quebec, H3G 1H9

    Recruiting

  • Research Site 2

    Toronto, Ontario, M3B2S7

    Recruiting

Other trials in Canada

New Zealand1 site, 1 recruiting

  • Research Site 1

    Grafton, Auckland, 1010

    Recruiting

Other trials in New Zealand

About this study

Official title: 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

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.

Being tested
ARO-MAPT-SC, Placebo
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ARO-MAPT-SCDrug

    • single or multiple doses of ARO-MAPT-SC by subcutaneous (SC) injection

  • PlaceboDrug

    • calculated volume to match active treatment by SC administration
Study groups in NCT07221344
Study groupRoleWhat they receive
ARO-MAPT-SCExperimentalARO-MAPT-SC injection
Receives: Drug: ARO-MAPT-SC
PlaceboPlacebo comparatorSterile normal saline (0.9%)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Over Time

    Measured: Through End of Study (EOS; Day 315)

Secondary outcomes (15)

  1. PK of ARO-MAPT-SC: Maximum Observed Plasma Concentration (Cmax)

    Measured: Through 48 hours postdose

  2. PK of ARO-MAPT-SC: Time to Maximum Plasma Concentration (Tmax)

    Measured: Through 48 hours postdose

  3. PK of ARO-MAPT-SC: Area Under the Plasma Concentration (AUC) Versus Time Curve From Time Zero to 24 Hours (AUC0-24)

    Measured: Through 24 hours postdose

  4. PK of ARO-MAPT-SC: AUC Versus Time Curve From Time Zero to 48 Hours (AUC0-48)

    Measured: Through 48 hours postdose

  5. PK of ARO-MAPT-SC: AUC Versus Time Curve From Time Zero to the Last Quantifiable Plasma Concentration (AUC0-t)

    Measured: Through 48 hours postdose

  6. PK of ARO-MAPT-SC: AUC Versus Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf)

    Measured: Through 48 hours post-dose

  7. PK of ARO-MAPT-SC: Apparent Terminal Elimination Half-life (t1/2)

    Measured: Through 48 hours postdose

  8. PK of ARO-MAPT-SC: Apparent Systemic Clearance (CL/F)

    Measured: Through 48 hours postdose

  9. PK of ARO-MAPT-SC: Apparent Terminal-phase Volume of Distribution (Vz/F)

    Measured: Through 48 hours postdose

  10. PK of ARO-MAPT-SC: Amount Excreted (Ae) of Unchanged Drug in Urine From Time Zero to 24 Hours Postdose

    Measured: Through 24 hours postdose

  11. PK of ARO-MAPT-SC: Percentage of Administered Drug Recovered (Fe) in Urine From Time Zero to 24 Hours Postdose

    Measured: Through 24 hours postdose

  12. PK of ARO-MAPT-SC: Renal Clearance (CLR)

    Measured: Through 24 hours postdose

  13. Change from Baseline in Total Protein in Cerebral Spinal Fluid (CSF) Over Time

    Measured: Baseline through EOS (Day 315)

  14. Change from Baseline in Glucose in CSF Over Time

    Measured: Baseline through EOS (Day 315)

  15. Change from Baseline in Cell Count in CSF Over Time

    Measured: Baseline through EOS (Day 315)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2025
  2. Study start18 Nov 2025
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07221344
Sponsor's protocol ID
AROMAPT-SC-1001
Status last verified
Sep 2026
First submitted
23 Oct 2025
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ARO-MAPT-SC in people with Alzheimer Disease and Alzheimer Disease, Early Onset, run by Arrowhead Pharmaceuticals at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Medical Monitor (626-304-3400, AROMAPT-SC-1001@arrowheadpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Over Time (time frame: Through End of Study (EOS; Day 315)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07221344.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

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