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NCT05231785 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety and Tolerability of ALN-APP in Patients With EOAD
A Phase 1 study of Early Onset Alzheimer Disease, sponsored by Alnylam Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 8
- Study locations
NCT05231785: Recruiting Phase 1 study of Early Onset Alzheimer Disease, sponsored by Alnylam Pharmaceuticals.
NCT05231785 is a Phase 1 study of Early Onset Alzheimer Disease that is actively recruiting participants, run by Alnylam Pharmaceuticals. The registered enrollment target is 60 participants, below the 623-participant average among 3 other Early Onset Alzheimer Disease trials with a reported enrollment target (90% lower). The trial reports 8 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05231785, a Phase 1 study of Early Onset Alzheimer Disease, is actively recruiting participants, sponsored by Alnylam Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 8
- Study locations
Study 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 Studied
Interventions
- DRUG Placebo
- DRUG ALN-APP
Study Locations (8)
Other
- Clinical Trial Site - Montreal
- Clinical Trial Site - Toronto
- Clinical Trial Site - Amsterdam
- Clinical Trial Site - Groningen
- Clinical Trial Site - Huntley Street
- Clinical Trial Site - Sheffield
California
- Clinical Trial Site - La Jolla
Indiana
- Clinical Trial Site - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-02-04 |
| Est. Completion | 2029-04-20 |
| Phase | Phase 1 |
What NCT05231785 shows while recruiting
NCT05231785 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 623-participant average among 3 other Early Onset Alzheimer Disease trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Early Onset Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05231785 lists 8 locations in 3 states (Other, California, Indiana).
Frequently Asked Questions
What is clinical trial NCT05231785 about?
NCT05231785 is a clinical study titled "A Study to Evaluate the Safety and Tolerability of ALN-APP in Patients With EOAD". 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 P...
What is the current status of trial NCT05231785?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2022-02-04. Estimated completion is 2029-04-20.
What conditions does trial NCT05231785 study?
This clinical trial studies the following conditions: Early Onset Alzheimer Disease.
What interventions are being tested in trial NCT05231785?
The interventions under investigation include: Placebo (DRUG), ALN-APP (DRUG).
Who is sponsoring clinical trial NCT05231785?
This trial is sponsored by Alnylam Pharmaceuticals, which has 49 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05231785 being conducted?
This trial has 8 study locations across California, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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