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RECRUITING Phase 1 ClinicalTrials.gov

A Study to Evaluate the Safety and Tolerability of ALN-APP in Patients With EOAD

Sponsor: Alnylam Pharmaceuticals • ClinicalTrials.gov ID: NCT05231785

Registry updated: 2026-10-20
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Description

The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of a single dose and multiple doses of ALN-APP administered by intrathecal (IT) injection in adult patients with early-onset Alzheimer's Disease (EOAD). Maximum treatment duration for Part A: single dose. Maximum treatment duration for Part B: 12 months.

Interventions

  • ALN-APP (Drug)
    ALN-APP will be administered intrathecally (IT)
  • Placebo (Drug)
    Placebo will be administered IT

Eligibility criteria

Inclusion Criteria: * Has mild cognitive impairment or mild dementia due to EOAD * Has Clinical Dementia Rating (CDR) global score 0.5 or 1.0 and Mini Mental State Examination (MMSE) \>20 Exclusion Criteria: * Has Non-Alzheimer's disease dementia * Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2×upper limit of normal (ULN) * Has estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73m\^2 at Screening * Has recently received an investigational agent * Has recent treatment with amyloid-targeting antibody Note: other protocol defined inclusion / exclusion criteria apply

Conditions

Early-Onset Alzheimer Disease

Locations

  • Clinical Trial Site — La Jolla, California, United States
  • Clinical Trial Site — Indianapolis, Indiana, United States
  • Clinical Trial Site — Montreal, Canada
  • Clinical Trial Site — Toronto, Canada
  • Clinical Trial Site — Amsterdam, Netherlands
  • Clinical Trial Site — Groningen, Netherlands
  • Clinical Trial Site — Huntley Street, United Kingdom
  • Clinical Trial Site — Sheffield, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record