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RecruitingNCT07221344Updated Sep 18, 2026

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

A Phase 1/2 interventional study of ARO-MAPT-SC and Placebo in Alzheimer Disease and Alzheimer Disease, Early Onset, sponsored by Arrowhead Pharmaceuticals. Recruiting at 4 sites in 2 countries. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by Arrowhead Pharmaceuticals · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alzheimer Disease
  • Alzheimer Disease, Early Onset

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03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.

04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
112 participants (estimated)

Study arms

  • Experimental
    ARO-MAPT-SC

    ARO-MAPT-SC injection

    Drug: ARO-MAPT-SC

  • Placebo comparator
    Placebo

    Sterile normal saline (0.9%)

    Drug: Placebo

Interventions

  • DrugARO-MAPT-SC

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

  • DrugPlacebo

    • calculated volume to match active treatment by SC administration

05

What researchers measure

Primary outcomes

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

    Time frame: Through End of Study (EOS; Day 315)

Secondary outcomes

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

    Time frame: Through 48 hours postdose

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

    Time frame: 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)

    Time frame: Through 24 hours postdose

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

    Time frame: 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)

    Time frame: Through 48 hours postdose

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

    Time frame: Through 48 hours post-dose

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

    Time frame: Through 48 hours postdose

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

    Time frame: Through 48 hours postdose

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

    Time frame: 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

    Time frame: 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

    Time frame: Through 24 hours postdose

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

    Time frame: Through 24 hours postdose

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

    Time frame: Baseline through EOS (Day 315)

  14. Change from Baseline in Glucose in CSF Over Time

    Time frame: Baseline through EOS (Day 315)

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

    Time frame: Baseline through EOS (Day 315)

06

Study locations

4 of 4 sites recruiting
  • Research Site 3
    East York, Ontario M4G 3E8, Canada
    Recruiting
  • Research Site 2
    Toronto, Ontario M3B2S7, Canada
    Recruiting
  • Research Site 4
    Montreal, Quebec H3G 1H9, Canada
    Recruiting
  • Research Site 1
    Grafton, Auckland 1010, New Zealand
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07221344
Lead sponsor
Arrowhead Pharmaceuticals
Responsible party
Sponsor
First posted
Oct 27, 2025
Start date
Nov 18, 2025
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Sep 18, 2026

Study contacts

Medical Monitor
Contact
AROMAPT-SC-1001@arrowheadpharma.com
626-304-3400

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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