About the study

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

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Has mild cognitive impairment or mild dementia due to EOAD
2. Has Clinical Dementia Rating (CDR) global score 0.5 or 1.0 and Mini Mental State Examination (MMSE) >20

Exclusion criteria

1. Has Non-Alzheimer's disease dementia
2. Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2×upper limit of normal (ULN)
3. Has estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m^2 at Screening
4. Has recently received an investigational agent
5. Has recent treatment with amyloid-targeting antibody

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.