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Recruiting
NCT07214727
A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease
Conditions: Alzheimer's Disease
Sex: All
Ages: 40 Years – 80 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 50
Sponsor: Alnylam Pharmaceuticals
Location: Clinical Trial Site Montreal
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
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 \
Source: ClinicalTrials.gov (NCT07214727). StuddyBuddy aggregates publicly available trial information.