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

Alnylam Pharmaceuticals · NCT05231785

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1
Target enrollment
60
US sites recruiting
1
Study start
February 4, 2022
Record last updated
October 20, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: ALN-APP; Placebo

Conditions: Early-Onset Alzheimer Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

Study contacts (from the official record)

  • Alnylam Clinical Trial Information Line · 1-877-ALNYLAM · clinicaltrials@alnylam.com
  • Alnylam Clinical Trial Information Line · 1-877-256-9526 · clinicaltrials@alnylam.com
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A Study to Evaluate the Safety and Tolerability of ALN-APP in… (NCT05231785) | Bored Studies