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

NCT07214727

RecruitingPhase 1

Sponsor: Alnylam Pharmaceuticals

Conditions: Alzheimer's Disease

Interventions: ALN-5288, Placebo

Countries: Canada, Netherlands, Spain, United Kingdom

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

Eligibility overview

Sex: ALL

Age: 40 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (13)
  • Montreal, Canada
  • Ottawa, Canada
  • Toronto, Canada
  • Toronto, Canada
  • 's-Hertogenbosch, Netherlands
  • Amsterdam, Netherlands
  • Barcelona, Spain
  • Madrid, Spain
  • Sant Cugat del Vallès, Spain
  • Glasgow, United Kingdom
  • London, United Kingdom
  • Sheffield, United Kingdom
  • Southampton, United Kingdom