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

NCT05231785

RecruitingPhase 1

Sponsor: Alnylam Pharmaceuticals

Conditions: Early-Onset Alzheimer Disease

Interventions: ALN-APP, Placebo

Countries: United States, Canada, Netherlands, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (8)
  • La Jolla, California, United States
  • Indianapolis, Indiana, United States
  • Montreal, Canada
  • Toronto, Canada
  • Amsterdam, Netherlands
  • Groningen, Netherlands
  • Huntley Street, United Kingdom
  • Sheffield, United Kingdom