Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06393712
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-04-19
Brief Title:
A Phase 2 Trial of ALN-APP in Patients With Cerebral Amyloid Angiopathy
Sponsor:
Alnylam Pharmaceuticals
Organization:
Alnylam Pharmaceuticals
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
cAPPricorn-1
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-510137-29-00 | CTIS | None | None |