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Recruiting NCT07221344

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

Phase I / Phase II Interventional Alzheimer Disease Alzheimer Disease, Early Onset

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ARO-MAPT-SC, Placebo.
Who it may be relevant to
Registry conditions: Alzheimer Disease, Alzheimer Disease, Early Onset. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada, New Zealand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug ARO-MAPT-SC
    • single or multiple doses of ARO-MAPT-SC by subcutaneous (SC) injection
  • Drug Placebo
    • calculated volume to match active treatment by SC administration

Primary outcome measures

  • Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Over Time [Time frame: Through End of Study (EOS), Day 270]
Secondary outcome measures (12)
  • PK of ARO-MAPT-SC: Maximum Observed Plasma Concentration (Cmax) [Time frame: Through 48 hours postdose]
  • PK of ARO-MAPT-SC: Time to Maximum Plasma Concentration (Tmax) [Time frame: Through 48 hours postdose]
  • 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]
  • PK of ARO-MAPT-SC: AUC Versus Time Curve From Time Zero to 48 Hours (AUC0-48) [Time frame: Through 48 hours postdose]
  • 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]
  • PK of ARO-MAPT-SC: AUC Versus Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) [Time frame: Through 48 hours post-dose]
  • PK of ARO-MAPT-SC: Apparent Terminal Elimination Half-life (t1/2) [Time frame: Through 48 hours postdose]
  • PK of ARO-MAPT-SC: Apparent Systemic Clearance (CL/F) [Time frame: Through 48 hours postdose]
  • PK of ARO-MAPT-SC: Apparent Terminal-phase Volume of Distribution (Vz/F) [Time frame: Through 48 hours postdose]
  • 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]
  • 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]
  • PK of ARO-MAPT-SC: Renal Clearance (CLR) [Time frame: Through 24 hours postdose]

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 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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Canada · 2 centers
  • Research Site 3 — East York
  • Research Site 2 — Toronto
New Zealand · 1 center
  • Research Site 1 — Grafton

Identifiers

NCT: NCT07221344 · AROMAPT-SC-1001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗