Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study to Evaluate the Safety and Tolerability of ALN-APP in Patients With EOAD
Sponsor: Alnylam Pharmaceuticals
Summary
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.
Official title: A Randomized, Double-blind, Placebo-controlled Single Ascending Dose and Open-label Multi-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ALN-APP in Adult Patients With Early-onset Alzheimer's Disease (EOAD)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2022-02-04
Completion Date
2029-04-20
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
ALN-APP
ALN-APP will be administered intrathecally (IT)
Placebo
Placebo will be administered IT
Locations (8)
Clinical Trial Site
La Jolla, California, United States
Clinical Trial Site
Indianapolis, Indiana, United States
Clinical Trial Site
Montreal, Canada
Clinical Trial Site
Toronto, Canada
Clinical Trial Site
Amsterdam, Netherlands
Clinical Trial Site
Groningen, Netherlands
Clinical Trial Site
Huntley Street, United Kingdom
Clinical Trial Site
Sheffield, United Kingdom