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

Study acronym: cAPPricorn-1
StatusActive, Not Recruiting
PhasePhase 2
Started2024-05-17
View on ClinicalTrials.gov ↗

Amendment history

2026-09-02
notable
Study Status, Study Design, Contacts/Locations v26
Trial sites expanded: 44 → 57 locations
Enrollment closed, study ongoing
Trial sites reduced: 57 → 44 locations
Enrollment targetestimated 200→confirmed 210
2026-07-14
minor
3 amendments v23-v25
3 re-verifications since 2026-05-12, no change to tracked fields
2026-04-23
minor
Study Status, Contacts/Locations v22
Study sitesdetails revised at 36 of 57 sites
2026-03-30
minor
Study Status v21
Re-verified, no change to tracked fields
2026-02-19
minor
Study Status, Contacts/Locations v20
Primary completion date2027-07-01→2027-08-09
Completion date2029-11-01→2029-12-14
Study sites42→57
Show 19 earlier versions
2025-12-18
minor
Study Status, Contacts/Locations v19
Study sites51→42
2025-11-12
minor
Study Status, Contacts/Locations v18
Study sites49→51
2025-11-08
minor
Study Status, Contacts/Locations v17
Study sitescontacts updated at 1 of 49 sites
2025-10-15
minor
Study Status, Contacts/Locations v16
Study sites47→49
2025-09-16
minor
Study Status, Contacts/Locations v15
Study sites44→47
2025-08-27
minor
Study Status, Contacts/Locations, IPDSharing v14
Study sites39→44
2025-07-15
minor
2 amendments v12-v13
2 re-verifications since 2025-06-16, no change to tracked fields
2025-05-12
minor
Study Status, Contacts/Locations v11
Study sites36→39
2025-04-15
minor
Study Status, Contacts/Locations v10
Study sites20→36
2025-03-21
minor
Study Status, Contacts/Locations v9
Study sites13→20
2024-12-04
minor
Study Status, Contacts/Locations v8
Study sites9→13
2024-11-07
minor
Study Status v7
Re-verified, no change to tracked fields
2024-10-11
minor
Study Status, Contacts/Locations v6
Study sites5→9
2024-09-06
minor
Study Status, Contacts/Locations v5
Study sites4→5
2024-08-07
minor
Study Status, Contacts/Locations v4
Study sites2→4
2024-07-18
minor
Study Status, Contacts/Locations v3
Primary completion date2027-07→2027-07-01
Completion date2029-11→2029-11-01
Study sites1→2
2024-06-24
minor
Study Status v2
Start dateestimated 2024-05→confirmed 2024-05-17
2024-05-09
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2024-04→2024-05
Study sites0→1
2024-04-26
minor
Original filing
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.
Trial Details
NCT Number NCT06393712
Lead Sponsor Alnylam Pharmaceuticals
Conditions Cerebral Amyloid Angiopathy
Enrollment 210 participants
Start Date 2024-05-17
Primary Completion 2027-08-09 (estimated)
Study Completion 2029-12-14 (estimated)
Updated on ClinicalTrials.gov 2026-09-18