ALN-APP for Early-Onset Alzheimer's Disease

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

Recruiting Phase 1 Interventional Study
Early-Onset Alzheimer Disease
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Alnylam Pharmaceuticals · Industry
Who this trial is looking for

This trial is looking for adults with early-onset Alzheimer's disease. Participants will receive ALN-APP through an injection to help assess its safety and how the body processes it.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have mild cognitive impairment or mild dementia due to early-onset Alzheimer's disease.
  • I have a Clinical Dementia Rating (CDR) score of 0.5 or 1.0.
  • I have a Mini Mental State Examination (MMSE) score greater than 20.

You may not be able to join if

  • I have non-Alzheimer's disease dementia.
  • I have liver enzyme levels significantly higher than normal.
  • My estimated kidney function is below 45 mL/min/1.73m².
  • I have received an investigational agent recently.
  • I have been treated with an amyloid-targeting antibody recently.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

Check Your Eligibility
About This Trial

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.

Trial Locations
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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 …
Contacts

Alnylam Clinical Trial Information Line

1-877-ALNYLAM

clinicaltrials@alnylam.com

CONTACT

Alnylam Clinical Trial Information Line

1-877-256-9526

clinicaltrials@alnylam.com

CONTACT