Actively Recruiting
A Study to Evaluate the Safety and Tolerability of ALN-APP in Patients With EOAD
Led by Alnylam Pharmaceuticals · Updated on 2026-05-07
60
Participants Needed
8
Research Sites
376 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
A Study to Evaluate the Safety and Tolerability of ALN-APP in Patients With EOAD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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/1.73m² at Screening
- Has recently received an investigational agent
- Has recent treatment with amyloid-targeting antibody
- Other protocol defined inclusion/exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Clinical Trial Site
La Jolla, California, United States, 92037
Completed
2
Clinical Trial Site
Indianapolis, Indiana, United States, 46202
Actively Recruiting
3
Clinical Trial Site
Montreal, Canada, H3A 2B4
Actively Recruiting
4
Clinical Trial Site
Toronto, Canada, M3B 2S7
Actively Recruiting
5
Clinical Trial Site
Amsterdam, Netherlands, 1081 BT
Actively Recruiting
6
Clinical Trial Site
Groningen, Netherlands, 9713 GG
Completed
7
Clinical Trial Site
Huntley Street, United Kingdom, WC1E 6AG
Actively Recruiting
8
Clinical Trial Site
Sheffield, United Kingdom, S10 2JF
Actively Recruiting
Research Team
A
Alnylam Clinical Trial Information Line
CONTACT
A
Alnylam Clinical Trial Information Line
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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