Early-Onset Alzheimer Disease study: ALN-APP
Official title A Study to Evaluate the Safety and Tolerability of ALN-APP in Patients With EOAD
ClinicalTrials.gov ID: NCT05231785
What this study is testing
What is ALN-APP?
An investigational intrathecal injection being studied for early‑onset Alzheimer disease.
Also referred to as mivelsiran.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will look at how safe and well the drug is tolerated, and how it behaves in the body after one or more injections.
- Who it's for
- Adults who have early‑onset Alzheimer’s disease.
- What's involved
- Participants will receive a single or multiple spinal injections of ALN-APP and will have blood and other tests to monitor safety and drug levels.
- Time commitment
- Part A lasts up to one injection; Part B can last up to 12 months with scheduled visits for monitoring.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Has mild cognitive impairment or mild dementia due to EOAD
- Has Clinical Dementia Rating (CDR) global score 0.5 or 1.0 and Mini Mental State Examination (MMSE) \>20
You likely can't join if
- Has Non-Alzheimer's disease dementia
- Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2×upper limit of normal (ULN)
- Has estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73m\^2 at Screening
- Has recently received an investigational agent
- Has recent treatment with amyloid-targeting antibody Note: other protocol defined inclusion / exclusion criteria apply
The study team makes the final eligibility decision.
Where it is enrolling
- Indianapolis, Indiana, United States
- Montreal, Canada
- Toronto, Canada
- Amsterdam, Netherlands
- Huntley Street, United Kingdom
- Sheffield, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Indianapolis, Indiana, United States; Montreal, Canada; Toronto, Canada; Amsterdam, Netherlands; Huntley Street, United Kingdom; Sheffield, United Kingdom. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.