A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease
ConditionAlzheimer's Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age40-80
SponsorAlnylam Pharmaceuticals
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ALN-5288
- Placebo
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Alnylam Pharmaceuticals
Lead sponsor
Regeneron Pharmaceuticals
Collaborator
Source ClinicalTrials.gov