A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease

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 (PK) effects of ALN-5288 after dose administration

Interventions

• ALN-5288 · DRUG

  ALN-5288 will be administered IT.

• Placebo · DRUG

  Placebo will be administered IT.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (13)

• Clinical Trial Site, Montreal, Canada · RECRUITING
• Clinical Trial Site, Ottawa, Canada · RECRUITING
• Clinical Trial Site, Toronto, Canada · RECRUITING
• Clinical Trial Site, Toronto, Canada · NOT_YET_RECRUITING
• Clinical Trial Site, 's-Hertogenbosch, Netherlands · RECRUITING
• Clinical Trial Site, Amsterdam, Netherlands · RECRUITING
• Clinical Trial Site, Barcelona, Spain · NOT_YET_RECRUITING
• Clinical Trial Site, Madrid, Spain · RECRUITING
• Clinical Trial Site, Sant Cugat del Vallès, Spain · NOT_YET_RECRUITING
• Clinical Trial Site, Glasgow, United Kingdom · RECRUITING
• Clinical Trial Site, London, United Kingdom · RECRUITING
• Clinical Trial Site, Sheffield, United Kingdom · RECRUITING
• Clinical Trial Site, Southampton, United Kingdom · RECRUITING