A Phase 2 Trial of ALN-APP in Patients With Cerebral Amyloid Angiopathy
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Cerebral Amyloid Angiopathy
In brief
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. The estimated duration of study participation, inclusive of screening, treatment, and additional safety follow-up, is up to 50 months.
Key facts
- Study ID
- NCT06393712
- Run by
- Alnylam Pharmaceuticals
- People needed
- 200
- Starts
- 2024-05-17
- Expected to finish
- 2029-12-14
- Last updated by the study team
- 2026-07-15
Who can join
Age: 30 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify 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
Where it is running
- Clinical Trial Site — Amsterdam, Netherlands (enrolling)
- Clinical Trial Site — Montreal, Canada (enrolling)
- Clinical Trial Site — Hamilton, Canada (enrolling)
- Clinical Trial Site — Victoria, Canada (enrolling)
- Clinical Trial Site — Glasgow, United Kingdom (enrolling)
- Clinical Trial Site — Ottawa, Canada (enrolling)
- Clinical Trial Site — Heidelberg, Australia (enrolling)
- Clinical Trial Site — Calgary, Canada (enrolling)
- Clinical Trial Site — Montreal, Canada (enrolling)
- Clinical Trial Site — Toronto, Canada (enrolling)
- Clinical Trial Site — Bern, Switzerland (enrolling)
- Clinical Trial Site — Geneva, Switzerland (enrolling)
- Clinical Trial Site — Nijmegen, Netherlands (enrolling)
- Clinical Trial Site — Leiden, Netherlands (enrolling)
- Clinical Trial Site — Adelaide, Australia (enrolling)
- Clinical Trial Site — Brisbane, Australia (enrolling)
- Clinical Trial Site — Nedlands, Australia (enrolling)
- Clinical Trial Site — Parkville, Australia (enrolling)
- Clinical Trial Site — Kelowna, Canada (enrolling)
- Clinical Trial Site — Moncton, Canada (enrolling)
- Clinical Trial Site — Boston, Massachusetts, United States
- Clinical Trial Site — New Orleans, Louisiana, United States
- Clinical Trial Site — New Haven, Connecticut, United States
- Clinical Trial Site — Lexington, Kentucky, United States
- Clinical Trial Site — Canton, Ohio, United States
Full record on ClinicalTrials.gov
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