Status:
RECRUITING
A Study to Evaluate the Safety and Tolerability of ALN-APP in Patients With EOAD
Lead Sponsor:
Alnylam Pharmaceuticals
Conditions:
Early-Onset Alzheimer Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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) injec...
Eligibility Criteria
Inclusion
- Has mild cognitive impairment or mild dementia due to EOAD
- Has Clinical Dementia Rating (CDR) global score 0.5 or 1.0 and Mini Mental State Examination (MMSE) \>20
Exclusion
- Has Non-Alzheimer's disease dementia
- Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2×upper limit of normal (ULN)
- Has estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73m\^2 at Screening
- Has recently received an investigational agent
- Has recent treatment with amyloid-targeting antibody
- Note: other protocol defined inclusion / exclusion criteria apply
Key Trial Info
Start Date :
February 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 28 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05231785
Start Date
February 4 2022
End Date
March 28 2029
Last Update
December 19 2025
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Trial Site
La Jolla, California, United States, 92037
2
Clinical Trial Site
Indianapolis, Indiana, United States, 46202
3
Clinical Trial Site
Toronto, Ontario, Canada, M3B 2S7
4
Clinical Trial Site
Montreal, Quebec, Canada, H3A 2B4