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RECRUITING
NCT05231785
PHASE1

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

Sponsor: Alnylam Pharmaceuticals

View on ClinicalTrials.gov

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

Interventions

DRUG

ALN-APP

ALN-APP will be administered intrathecally (IT)

DRUG

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