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NCT06393712PHASE2Recruiting

A Phase 2 Trial of ALN-APP in Patients With Cerebral Amyloid Angiopathy

Alnylam Pharmaceuticals

Start Date

5/17/2024

Completion Date

12/14/2029

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.

Eligibility Criteria

Age Range: 30 years to No maximum

Inclusion Criteria (sporadic CAA patients): * Is 50 years or older * Has probable CAA per the Boston Criteria Version 2.0 Inclusion Criteria (Dutch-type CAA patients): * Is 30 years or older * Has known E693Q amyloid precursor protein (APP) gene mutation for Dutch-type CAA Exclusion Criteria: * 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

Interventions

DRUG

Placebo

DRUG

ALN-APP

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Conditions

Cerebral Amyloid Angiopathy

Locations

Clinical Trial Site

Los Angeles, California 90095

United States

Clinical Trial Site

Orange, California 92868

United States

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Palo Alto, California 94304

United States

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Sacramento, California 95816

United States

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San Francisco, California 94114

United States

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Aurora, Colorado 80045

United States

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New Haven, Connecticut 06510

United States

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Gainesville, Florida 32608

United States

Clinical Trial Site

Jacksonville, Florida 32224

United States

Clinical Trial Site

Maitland, Florida 32751

United States

Clinical Trial Site

Naples, Florida 34105

United States

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Chicago, Illinois 60612

United States

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Lexington, Kentucky 40504

United States

Clinical Trial Site

New Orleans, Louisiana 70121

United States

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Boston, Massachusetts 02114

United States

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Plymouth, Massachusetts 02360

United States

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Rochester, Minnesota 55905

United States

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St Louis, Missouri 63110

United States

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Hackensack, New Jersey 07601

United States

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New York, New York 10016

United States

Clinical Trial Site

New York, New York 10029

United States

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New York, New York 10032

United States

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New York, New York 10065

United States

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Durham, North Carolina 27705

United States

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Canton, Ohio 44718

United States

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Cleveland, Ohio 44195

United States

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Abington, Pennsylvania 19001

United States

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Philadelphia, Pennsylvania 19104

United States

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Pittsburgh, Pennsylvania 15213

United States

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Dallas, Texas 75243

United States

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Dallas, Texas 75390

United States

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Houston, Texas 77030

United States

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San Antonio, Texas 78229

United States

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Seattle, Washington 98104

United States

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Adelaide, 5000

Australia

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Brisbane, 4029

Australia

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Heidelberg, 3084

Australia

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Nedlands, 6009

Australia

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Parkville, 3050

Australia

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Calgary, T2N 4Z6

Canada

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Hamilton, L8L 2X2

Canada

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Kelowna, V1Y 1Z9

Canada

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Moncton, E1C 2Z3

Canada

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Montreal, H3A 2B4

Canada

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Montreal, H3G 1H9

Canada

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Ottawa, K1Z 1G3

Canada

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Toronto, M3B 2S7

Canada

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Victoria, V8R 1J8

Canada

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Amsterdam, 1081 GN

Netherlands

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Leiden, 2333ZA

Netherlands

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Nijmegen, 6525 GA

Netherlands

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Bern, 3010

Switzerland

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Geneva, 1205

Switzerland

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Sankt Gallen, 9007

Switzerland

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Glasgow, G51 4TF

United Kingdom

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London, SE5 8AF

United Kingdom

Clinical Trial Site

London, WC1N 3BG

United Kingdom