A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease
Recruiting · NCT07214727 · Interventional (participants receive a specific treatment) · Lead sponsor: Alnylam Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
ALN-5288Placebo
What this trial is about
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
Who can take part
Age range
40 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
13 locations listed.
- Clinical Trial Site - 's-Hertogenbosch, Netherlands
- Clinical Trial Site - Amsterdam, Netherlands
- Clinical Trial Site - Barcelona, Spain
- Clinical Trial Site - Glasgow, United Kingdom
- Clinical Trial Site - London, United Kingdom
- Clinical Trial Site - Madrid, Spain
- Clinical Trial Site - Montreal, Canada
- Clinical Trial Site - Ottawa, Canada
- Clinical Trial Site - Sant Cugat del Vallès, Spain
- Clinical Trial Site - Sheffield, United Kingdom
- Clinical Trial Site - Southampton, United Kingdom
- Clinical Trial Site - Toronto, Canada
- Clinical Trial Site - Toronto, Canada