Trials / Recruiting
RecruitingNCT05231785
A Study to Evaluate the Safety and Tolerability of ALN-APP in Patients With EOAD
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)
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Alnylam Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALN-APP | ALN-APP will be administered intrathecally (IT) |
| DRUG | Placebo | Placebo will be administered IT |
Timeline
- Start date
- 2022-02-04
- Primary completion
- 2029-04-20
- Completion
- 2029-04-20
- First posted
- 2022-02-09
- Last updated
- 2026-03-31
Locations
8 sites across 4 countries: United States, Canada, Netherlands, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05231785. Inclusion in this directory is not an endorsement.