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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
ALN-5288
DrugALN-5288 will be administered IT.
Placebo
DrugPlacebo will be administered IT.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: ALN-5288Experimental treatment 1 intervention
Group B: Placebo + ALN-5288Placebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Frequency of Adverse Events (AEs)
Time frame
Up to 32 months2
Severity of AEs
Time frame
Up to 32 monthsSecondary outcomes
1
Concentration of Total Tau (t-Tau) Protein in CSF Over Time
Time frame
Up to 32 months2
Change from Baseline in Concentration of t-Tau Protein in CSF Over Time
Time frame
Up to 32 months3
Concentration of ALN-5288 in Plasma Over Time (Ct)
Time frame
Up to 32 months4
Change from Baseline in Concentration of ALN-5288 CSF Ct
Time frame
Up to 32 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Alnylam Pharmaceuticals
Lead sponsor
Regeneron Pharmaceuticals
Collaborator
Source ClinicalTrials.gov