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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
Clinical Trial Site
Montreal, Canada
RECRUITINGClinical Trial Site
Ottawa, Canada
RECRUITINGFrequency of Adverse Events (AEs)
Time frame: Up to 32 months
Severity of AEs
Time frame: Up to 32 months
Concentration of Total Tau (t-Tau) Protein in CSF Over Time
Time frame: Up to 32 months
Change from Baseline in Concentration of t-Tau Protein in CSF Over Time
Time frame: Up to 32 months
Concentration of ALN-5288 in Plasma Over Time (Ct)
Time frame: Up to 32 months
Change from Baseline in Concentration of ALN-5288 CSF Ct
Time frame: Up to 32 months
Concentration of ALN-5288 in Plasma
Time frame: Up to 32 months
Concentration of ALN-5288 in Urine
Time frame: Up to 32 months
Concentration of ALN-5288 in CSF
Time frame: Up to 32 months
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Clinical Trial Site
Toronto, Canada
RECRUITINGClinical Trial Site
Toronto, Canada
NOT_YET_RECRUITINGClinical Trial Site
's-Hertogenbosch, Netherlands
RECRUITINGClinical Trial Site
Amsterdam, Netherlands
RECRUITINGClinical Trial Site
Barcelona, Spain
NOT_YET_RECRUITINGClinical Trial Site
Madrid, Spain
RECRUITINGClinical Trial Site
Sant Cugat del Vallès, Spain
NOT_YET_RECRUITINGClinical Trial Site
Glasgow, United Kingdom
RECRUITING...and 3 more locations