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 groupsLocations
13Canada
Clinical Trial SiteH3G 1H9, Montreal Canada
Clinical Trial SiteK1Z 1G3, Ottawa Canada
Clinical Trial SiteM3B 2S7, Toronto Canada
Clinical Trial SiteM5T 2S8, Toronto Canada
Sponsors and collaborators
Alnylam Pharmaceuticals
Lead sponsor
Regeneron Pharmaceuticals
Collaborator
Source ClinicalTrials.gov