* 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
Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
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 \<45 mL/min/1.73 m\^2 at screening
* Has clinically significant ECG abnormalities at screening
* Has uncontrolled psychiatric disease, including patients deemed by the Investigator to be at significant risk of suicide, major depressive episode, psychosis, confusional state, or violent behavior
* Has history of bleeding diathesis or coagulopathy due to chronic conditions
* Has a medical history of brain or spinal disease that would interfere with the IT injection and LP procedures
* Has history of uncontrolled seizures within the last 6 months prior to Screening
Primary outcome measure(s)
Frequency of Adverse Events (AEs) — Up to 32 months
Severity of AEs — Up to 32 months
Trial sites (13)
Facility
City
Region
Status
Clinical Trial Site
Montreal
Canada
Recruiting
Clinical Trial Site
Ottawa
Canada
Recruiting
Clinical Trial Site
Toronto
Canada
Recruiting
Clinical Trial Site
Toronto
Canada
Not Yet Recruiting
Clinical Trial Site
's-Hertogenbosch
Netherlands
Recruiting
Clinical Trial Site
Amsterdam
Netherlands
Recruiting
Clinical Trial Site
Barcelona
Spain
Not Yet Recruiting
Clinical Trial Site
Madrid
Spain
Recruiting
Clinical Trial Site
Sant Cugat del Vallès
Spain
Not Yet Recruiting
Clinical Trial Site
Glasgow
United Kingdom
Recruiting
Clinical Trial Site
London
United Kingdom
Recruiting
Clinical Trial Site
Sheffield
United Kingdom
Recruiting
Clinical Trial Site
Southampton
United Kingdom
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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