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A Phase 2 Trial of ALN-APP in Patients With Cerebral Amyloid Angiopathy
Sponsor: Alnylam Pharmaceuticals
Summary
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.
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Intrathecally Administered ALN-APP in Patients With Cerebral Amyloid Angiopathy (CAA)
Key Details
Gender
All
Age Range
30 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2024-05-17
Completion Date
2029-12-14
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
Placebo
Placebo will be administered intrathecally
ALN-APP
ALN-APP will be administered intrathecally
Locations (57)
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Los Angeles, California, United States
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Orange, California, United States
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Palo Alto, California, United States
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Sacramento, California, United States
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San Francisco, California, United States
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Aurora, Colorado, United States
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New Haven, Connecticut, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Maitland, Florida, United States
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Naples, Florida, United States
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Chicago, Illinois, United States
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Lexington, Kentucky, United States
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New Orleans, Louisiana, United States
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Boston, Massachusetts, United States
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Plymouth, Massachusetts, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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Hackensack, New Jersey, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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Durham, North Carolina, United States
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Canton, Ohio, United States
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Cleveland, Ohio, United States
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Abington, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Seattle, Washington, United States
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Adelaide, Australia
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Brisbane, Australia
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Heidelberg, Australia
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Nedlands, Australia
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Parkville, Australia
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Calgary, Canada
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Hamilton, Canada
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Kelowna, Canada
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Moncton, Canada
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Montreal, Canada
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Montreal, Canada
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Ottawa, Canada
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Toronto, Canada
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Victoria, Canada
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Amsterdam, Netherlands
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Leiden, Netherlands
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Nijmegen, Netherlands
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Bern, Switzerland
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Geneva, Switzerland
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Sankt Gallen, Switzerland
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Glasgow, United Kingdom
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London, United Kingdom
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London, United Kingdom