BridgeMD
New treatment option for Cerebral Amyloid Angiopathy
Official title A Phase 2 Trial of ALN-APP in Patients With Cerebral Amyloid Angiopathy
ClinicalTrials.gov ID: NCT06393712
What this study is testing
What is ALN-APP?
ALN-APP is an investigational medicine, being studied as a potential treatment for cerebral amyloid angiopathy.
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 purpose of the study is to evaluate the effect of ALN-APP on measures of CAA disease progression and to characterize the safety, tolerability, and pharmacodynamics (PD) of ALN-APP in adult patients with sporadic CAA (sCAA) and Dutch-type CAA (D-CAA). The study will be conducted over 2 periods: a 24-month double-blind treatment period and an optional 18-month open-label extension (OLE) period.
- Phase 2: a mid-size study of how well it works
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 and older
You may be able to join if
- (sporadic CAA patients):
- Is 50 years or older
- Has probable CAA per the Boston Criteria Version 2.0 (Dutch-type CAA patients):
- Is 30 years or older
- Has known E693Q amyloid precursor protein (APP) gene mutation for Dutch-type CAA
You likely can't join if
- Moderate or severe stage Alzheimer's disease (AD) or significant cognitive impairment (CI)
- Has a history of previous clinical intracerebral hemorrhage (ICH) with onset less than 90 days prior to anticipated randomization in the study
- Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3×upper limit of normal (ULN) at Screening
- Has estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m\^2 at Screening
- Has recently received an investigational agent
- Has had treatment with amyloid-targeting antibody Note: other protocol defined inclusion / exclusion criteria apply
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Maitland, Florida, United States
- Naples, Florida, United States
- Chicago, Illinois, United States
- Lexington, Kentucky, United States
- New Orleans, Louisiana, United States
- Boston, Massachusetts, United States
- Plymouth, Massachusetts, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Hackensack, New Jersey, United States
- New York, New York, United States
+ 31 more site(s).
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 - 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, 30 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Orange, California, United States; Palo Alto, California, United States; Sacramento, California, United States; San Francisco, California, United States; Aurora, Colorado, United States and 45 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.