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 participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since ALN-5288 is being tested in a Phase 1 trial focused on safety, what does that mean for my odds of seeing any benefit versus being exposed to unknown risks at this early stage?
2The trial is primarily measuring how often and how severe side effects are — given my current health and Alzheimer's progression, does my doctor think I'm in a position to take on that level of uncertainty?
3Are there any approved or standard-of-care treatments for my stage of Alzheimer's disease that my doctor would recommend I try before considering enrollment in a Phase 1 study like this one?
4What do we know so far about how ALN-5288 works in the body, and are there any early signals from preclinical or prior studies that my doctor thinks are worth discussing before I consider this trial?
5How would participating in this study affect my day-to-day life in terms of visits, monitoring, or restrictions — and would it interfere with any other treatments I'm currently receiving for Alzheimer's?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.