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A Study to Evaluate the Safety and Tolerability of ALN-APP in Patients With EOAD
NCT05231785 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05231785
The ClinicalTrials.gov registry entry for NCT05231785 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alnylam Pharmaceuticals, which has 81 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05231785 reports 8 study locations spanning 3 distinct geographic areas — top geographies include Other, California, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05231785?
The interventions under investigation include: Placebo (DRUG), ALN-APP (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05231785?
This trial is sponsored by Alnylam Pharmaceuticals, which has 81 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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