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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 \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07214727). StuddyBuddy aggregates publicly available trial information.