Status:
RECRUITING
A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease
Lead Sponsor:
Alnylam Pharmaceuticals
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
40-80 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to: * Evaluate the safety and tolerability of intrathecal (IT) ALN-5288 in patients with Alzheimer's Disease (AD) * Evaluate the pharmacodynamic (PD) and pharmacokinetic ...
Eligibility Criteria
Inclusion
- Is able and willing to meet all study requirements in the opinion of the Investigator
- Has a diagnosis of Alzheimer's disease (AD) based on clinical findings supported by cerebrospinal fluid (CSF) biomarkers or positive positron emission tomography (PET) amyloid imaging within 7 years prior to screening
- Has mild cognitive impairment (MCI) or dementia due to AD
Exclusion
- Has non-AD dementia
- Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2× upper limit of normal (ULN)
- Has total bilirubin \>1.5×ULN
- Has known human immunodeficiency virus infection
- Has history of hepatitis C virus or current hepatitis B virus infection
- Has systolic blood pressure \>160 mmHg and/or a diastolic blood pressure \>100 mmHg after 10 minutes of rest at screening
- Has an estimated glomerular filtration (eGFR) of \<45 mL/min/1.73 m\^2 at screening
- Has clinically significant ECG abnormalities at screening
- Has uncontrolled psychiatric disease, including patients deemed by the Investigator to be at significant risk of suicide, major depressive episode, psychosis, confusional state, or violent behavior
- Has history of bleeding diathesis or coagulopathy due to chronic conditions
- Has a medical history of brain or spinal disease that would interfere with the IT injection and LP procedures
- Has history of uncontrolled seizures within the last 6 months prior to Screening
Key Trial Info
Start Date :
October 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2030
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07214727
Start Date
October 15 2025
End Date
March 31 2030
Last Update
December 24 2025
Active Locations (13)
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1
Clinical Trial Site
Ottawa, Ontario, Canada, K1Z 1G3
2
Clinical Trial Site
Toronto, Ontario, Canada, M3B 2S7
3
Clinical Trial Site
Toronto, Ontario, Canada, M5T 2S8
4
Clinical Trial Site
Montreal, Quebec, Canada, H3G 1H9