Actively Recruiting

Phase 2
Age: 30Years +
All Genders
NCT06393712

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

Led by Alnylam Pharmaceuticals · Updated on 2026-05-14

200

Participants Needed

57

Research Sites

291 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 30Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • For sporadic CAA patients: 50 years or older
  • For sporadic CAA patients: Probable CAA diagnosis per Boston Criteria Version 2.0
  • For Dutch-type CAA patients: 30 years or older
  • For Dutch-type CAA patients: Known E693Q amyloid precursor protein (APP) gene mutation
Not Eligible

You will not qualify if you...

  • Moderate or severe Alzheimer's disease or significant cognitive impairment
  • Clinical intracerebral hemorrhage within 90 days prior to randomization
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times upper limit of normal at screening
  • Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m² at screening
  • Recent receipt of an investigational agent
  • Prior treatment with amyloid-targeting antibody
  • Other protocol defined exclusion criteria apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 57 locations

1

Clinical Trial Site

Los Angeles, California, United States, 90095

Active, Not Recruiting

2

Clinical Trial Site

Orange, California, United States, 92868

Active, Not Recruiting

3

Clinical Trial Site

Palo Alto, California, United States, 94304

Active, Not Recruiting

4

Clinical Trial Site

Sacramento, California, United States, 95816

Active, Not Recruiting

5

Clinical Trial Site

San Francisco, California, United States, 94114

Active, Not Recruiting

6

Clinical Trial Site

Aurora, Colorado, United States, 80045

Active, Not Recruiting

7

Clinical Trial Site

New Haven, Connecticut, United States, 06510

Active, Not Recruiting

8

Clinical Trial Site

Gainesville, Florida, United States, 32608

Active, Not Recruiting

9

Clinical Trial Site

Jacksonville, Florida, United States, 32224

Active, Not Recruiting

10

Clinical Trial Site

Maitland, Florida, United States, 32751

Active, Not Recruiting

11

Clinical Trial Site

Naples, Florida, United States, 34105

Active, Not Recruiting

12

Clinical Trial Site

Chicago, Illinois, United States, 60612

Active, Not Recruiting

13

Clinical Trial Site

Lexington, Kentucky, United States, 40504

Active, Not Recruiting

14

Clinical Trial Site

New Orleans, Louisiana, United States, 70121

Active, Not Recruiting

15

Clinical Trial Site

Boston, Massachusetts, United States, 02114

Active, Not Recruiting

16

Clinical Trial Site

Plymouth, Massachusetts, United States, 02360

Active, Not Recruiting

17

Clinical Trial Site

Rochester, Minnesota, United States, 55905

Active, Not Recruiting

18

Clinical Trial Site

St Louis, Missouri, United States, 63110

Active, Not Recruiting

19

Clinical Trial Site

Hackensack, New Jersey, United States, 07601

Active, Not Recruiting

20

Clinical Trial Site

New York, New York, United States, 10016

Active, Not Recruiting

21

Clinical Trial Site

New York, New York, United States, 10029

Active, Not Recruiting

22

Clinical Trial Site

New York, New York, United States, 10032

Active, Not Recruiting

23

Clinical Trial Site

New York, New York, United States, 10065

Active, Not Recruiting

24

Clinical Trial Site

Durham, North Carolina, United States, 27705

Active, Not Recruiting

25

Clinical Trial Site

Canton, Ohio, United States, 44718

Active, Not Recruiting

26

Clinical Trial Site

Cleveland, Ohio, United States, 44195

Active, Not Recruiting

27

Clinical Trial Site

Abington, Pennsylvania, United States, 19001

Active, Not Recruiting

28

Clinical Trial Site

Philadelphia, Pennsylvania, United States, 19104

Active, Not Recruiting

29

Clinical Trial Site

Pittsburgh, Pennsylvania, United States, 15213

Active, Not Recruiting

30

Clinical Trial Site

Dallas, Texas, United States, 75243

Active, Not Recruiting

31

Clinical Trial Site

Dallas, Texas, United States, 75390

Active, Not Recruiting

32

Clinical Trial Site

Houston, Texas, United States, 77030

Active, Not Recruiting

33

Clinical Trial Site

San Antonio, Texas, United States, 78229

Active, Not Recruiting

34

Clinical Trial Site

Seattle, Washington, United States, 98104

Active, Not Recruiting

35

Clinical Trial Site

Adelaide, Australia, 5000

Actively Recruiting

36

Clinical Trial Site

Brisbane, Australia, 4029

Actively Recruiting

37

Clinical Trial Site

Heidelberg, Australia, 3084

Actively Recruiting

38

Clinical Trial Site

Nedlands, Australia, 6009

Actively Recruiting

39

Clinical Trial Site

Parkville, Australia, 3050

Actively Recruiting

40

Clinical Trial Site

Calgary, Canada, T2N 4Z6

Actively Recruiting

41

Clinical Trial Site

Hamilton, Canada, L8L 2X2

Actively Recruiting

42

Clinical Trial Site

Kelowna, Canada, V1Y 1Z9

Actively Recruiting

43

Clinical Trial Site

Moncton, Canada, E1C 2Z3

Actively Recruiting

44

Clinical Trial Site

Montreal, Canada, H3A 2B4

Actively Recruiting

45

Clinical Trial Site

Montreal, Canada, H3G 1H9

Actively Recruiting

46

Clinical Trial Site

Ottawa, Canada, K1Z 1G3

Actively Recruiting

47

Clinical Trial Site

Toronto, Canada, M3B 2S7

Actively Recruiting

48

Clinical Trial Site

Victoria, Canada, V8R 1J8

Actively Recruiting

49

Clinical Trial Site

Amsterdam, Netherlands, 1081 GN

Actively Recruiting

50

Clinical Trial Site

Leiden, Netherlands, 2333ZA

Actively Recruiting

51

Clinical Trial Site

Nijmegen, Netherlands, 6525 GA

Actively Recruiting

52

Clinical Trial Site

Bern, Switzerland, 3010

Actively Recruiting

53

Clinical Trial Site

Geneva, Switzerland, 1205

Actively Recruiting

54

Clinical Trial Site

Sankt Gallen, Switzerland, 9007

Terminated

55

Clinical Trial Site

Glasgow, United Kingdom, G51 4TF

Actively Recruiting

56

Clinical Trial Site

London, United Kingdom, SE5 8AF

Active, Not Recruiting

57

Clinical Trial Site

London, United Kingdom, WC1N 3BG

Active, Not Recruiting

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Research Team

A

Alnylam Clinical Trial Information Line

CONTACT

A

Alnylam Clinical Trial Information Line

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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