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A Study to Evaluate the Safety and Tolerability of ALN-APP in Patients With EOAD

StatusRecruiting
PhasePhase 1
Started2022-02-04
View on ClinicalTrials.gov ↗

Amendment history

2026-09-10
7 amendments v43-v49
7 re-verifications since 2026-03-30, no change to tracked fields
2026-02-19
Study Status, Contacts/Locations v42
Primary completion date2029-03-28→2029-04-20
Completion date2029-03-28→2029-04-20
Study sitesdetails revised at 4 of 8 sites
2025-12-18
Study Status, Contacts/Locations v41
Study sitesdetails revised at 8 of 8 sites
2025-11-10
4 amendments v37-v40
4 re-verifications since 2025-08-25, no change to tracked fields
2025-07-25
Study Status v36
Primary completion date2025-07-01→2029-03-28
Completion date2029-03-01→2029-03-28
Show 35 earlier versions
2025-06-16
2 amendments v34-v35
2 re-verifications since 2025-05-09, no change to tracked fields
2025-02-03
Study Status v33
Completion date2027-07-01→2029-03-01
2025-01-23
Study Status v32
Re-verified, no change to tracked fields
2024-12-05
Study Status, Contacts/Locations v31
Study sitesdetails revised at 1 of 8 sites
2024-11-07
2 amendments v29-v30
2 re-verifications since 2024-10-02, no change to tracked fields
2024-09-06
Study Status, Contacts/Locations v28
Study sites7→8
2024-08-06
Study Status v27
Re-verified, no change to tracked fields
2024-07-18
Study Status v26
Primary completion date2025-07→2025-07-01
Completion date2027-07→2027-07-01
2024-06-25
Study Status v25
Re-verified, no change to tracked fields
2024-05-02
Study Identification, Study Status, Oversight, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v24
Completion date2025-07→2027-07
Study sites5→7
Eligibility criteria+66 characters
[...] l agent Has recent treatment with amyloid-targeting antibody Note: other protocol defined inclusion / exclusion criteria apply
Secondary endpoints5 entries, revised
Part A and Part B: Concentration of ALN-APP and Potential Metabolites at Time 't' (Ct) ofin ALN-APPPlasma and Potential MetabolitesCSF
2024-02-12
Study Status, Contacts/Locations v23
Study sites6→5
2024-02-01
Study Status v22
Re-verified, no change to tracked fields
2023-12-13
Study Status, Contacts/Locations v21
Study sites7→6
2023-11-14
3 amendments v18-v20
3 re-verifications since 2023-09-06, no change to tracked fields
2023-08-16
Study Status, Contacts/Locations v17
Study sites6→7
2023-06-16
2 amendments v15-v16
2 re-verifications since 2023-05-16, no change to tracked fields
2023-04-20
Study Status, Contacts/Locations v14
Study sitesdetails revised at 2 of 6 sites
2023-03-18
2 amendments v12-v13
2 re-verifications since 2023-02-15, no change to tracked fields
2023-01-19
Study Status, Contacts/Locations v11
Study sites4→6
2022-12-06
3 amendments v8-v10
3 re-verifications since 2022-10-14, no change to tracked fields
2022-09-15
Study Status, Contacts/Locations v7
Study sites2→4
2022-08-08
Study Status v6
Re-verified, no change to tracked fields
2022-07-14
Study Status, Contacts/Locations v5
Study sites1→2
2022-06-03
3 amendments v2-v4
3 re-verifications since 2022-04-11, no change to tracked fields
2022-03-14
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-01-31→confirmed 2022-02-04
Study sitesdetails revised at 1 of 1 site
2022-01-30
Original filing
The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of a single dose and multiple doses of ALN-APP administered by intrathecal (IT) injection in adult patients with early-onset Alzheimer's Disease (EOAD). Maximum treatment duration for Part A: single dose. Maximum treatment duration for Part B: 12 months.
Trial Details
NCT Number NCT05231785
Lead Sponsor Alnylam Pharmaceuticals
Conditions Early-Onset Alzheimer Disease
Enrollment 60 participants
Start Date 2022-02-04
Primary Completion 2029-04-20 (estimated)
Study Completion 2029-04-20 (estimated)
Updated on ClinicalTrials.gov 2026-09-14