A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease
Key facts
- Where
- Montreal, Ottawa, and Toronto, CanadaSee the 3 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 80 years old?
Where in Canada
- MontrealMontreal, CanadaTaking people
- OttawaOttawa, CanadaTaking people
- TorontoToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Alnylam Pharmaceuticals
- Trial code
- NCT07214727EU 2025-522582-30-00
- Record updated
- 8 October 2026
- Original description
The purpose of this study is to:Read full original descriptionShow less
A Phase 1, Randomized, Placebo-controlled Study With a Double Blind Period With Open-label Extension Period to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ALN-5288 in Adult Patients With Alzheimer's Disease
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
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 history of uncontrolled seizures within the last 6 months prior to Screening; Has non-AD dementia; Has known human immunodeficiency virus infection; Has history of hepatitis C virus or current hepatitis B virus infection; 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 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2× upper limit of normal (ULN); Has total bilirubin >1.5×ULN; Has an estimated glomerular filtration (eGFR) of <45 mL/min/1.73 m\^2 at screening; Has systolic blood pressure >160 mmHg and/or a diastolic blood pressure >100 mmHg after 10 minutes of rest at screening; Has clinically significant ECG abnormalities at screening.