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

RecruitingPhase 1Ages 18 Years - anyAllAlnylam Pharmaceuticals
NCT05231785 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • ALN-APP
  • Placebo
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Where

8 sites
Clinical Trial Site
La Jolla, United States
Clinical Trial Site
Indianapolis, 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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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