NCT06393712 A Phase 2 Trial of ALN-APP in Patients With Cerebral Amyloid Angiopathy
| NCT ID | NCT06393712 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Alnylam Pharmaceuticals |
| Condition | Cerebral Amyloid Angiopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-05-17 |
| Primary Completion | 2027-08-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2024-05-17 with a primary completion date of 2027-08-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Medical Director
STUDY DIRECTOR
Alnylam Pharmaceuticals
Frequently Asked Questions
Who can join the NCT06393712 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, studying Cerebral Amyloid Angiopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06393712 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06393712 currently recruiting?
Yes, NCT06393712 is actively recruiting participants. Contact the research team at clinicaltrials@alnylam.com for enrollment information.
Where is the NCT06393712 trial being conducted?
This trial is being conducted at Los Angeles, United States, Orange, United States, Palo Alto, United States, Sacramento, United States and 11 additional locations.
Who is sponsoring the NCT06393712 clinical trial?
NCT06393712 is sponsored by Alnylam Pharmaceuticals. The principal investigator is Medical Director at Alnylam Pharmaceuticals. The trial plans to enroll 200 participants.