A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease
Recruiting now Phase 1 NCT07214727
Run by Alnylam Pharmaceuticals · for 40 to 80 · All sexes
What this study is about
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 (PK) effects of ALN-5288 after dose administration
Who can join (things the study team will check)
✅ You may be able to join if…
- 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
🚫 You may not be able to join if…
- 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
Where this trial is running
- Clinical Trial Site, Montreal, Canada
- Clinical Trial Site, Ottawa, Canada
- Clinical Trial Site, Toronto, Canada
- Clinical Trial Site, Toronto, Canada
- Clinical Trial Site, 's-Hertogenbosch, Netherlands
- Clinical Trial Site, Amsterdam, Netherlands
- Clinical Trial Site, Barcelona, Spain
- Clinical Trial Site, Madrid, Spain
- Clinical Trial Site, Sant Cugat del Vallès, Spain
- Clinical Trial Site, Glasgow, United Kingdom
- Clinical Trial Site, London, United Kingdom
- Clinical Trial Site, Sheffield, United Kingdom
+ 1 more sites.
Who to contact
Clinical Trial Information Line · 1-877-ALNYLAM · clinicaltrials@alnylam.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07214727.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.
Beacon is an information tool, not medical advice. Whether a trial is right for you is a decision for you, your doctor, and the study team. Trial details come from the official registry, ClinicalTrials.gov, and may change — always confirm with the study team. Beacon collects no data about you: this page has no cookies, no accounts, and no tracking.