Evaluating ALN-APP for Early-Onset Alzheimer's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the safety and tolerability of ALN-APP, an investigational treatment, in patients with early-onset Alzheimer's Disease (EOAD). Participants will receive either a single dose or multiple doses of ALN-APP via intrathecal injection, with the first part of the study focusing on a single dose and the second part lasting up to 12 months. The study will also evaluate the pharmacodynamics and pharmacokinetics of the treatment. Patients will be monitored for cognitive impairment and overall health throughout the trial.

Why it matters

Who can join: the full rules

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

Where it's running

• Clinical Trial Site
  Indianapolis, Indiana, United States Recruiting
• Clinical Trial Site
  Montreal, Canada Recruiting
• Clinical Trial Site
  Toronto, Canada Recruiting
• Clinical Trial Site
  Amsterdam, Netherlands Recruiting
• Clinical Trial Site
  Huntley Street, United Kingdom Recruiting
• Clinical Trial Site
  Sheffield, United Kingdom Recruiting

Study contacts

• Study coordinator: Alnylam Clinical Trial Information Line
• Email: clinicaltrials@alnylam.com
• Phone: 1-877-ALNYLAM

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.