Clinical Trials in the Netherlands / NCT07214727
Recruiting
Phase 1
A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease
NCT07214727 · tracked via the Priya Life Science Netherlands tracker
Condition(s) studied
Alzheimer's Disease
Investigational drug(s) / intervention(s)
ALN-5288Placebo
ALN-5288: ALN-5288 will be administered IT.
Placebo: Placebo will be administered IT.
Study summary
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
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 |
More Alnylam Pharmaceuticals trials in the Netherlands
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Enrolling by invitation
Other trials for the same condition
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.
View NCT07214727 on ClinicalTrials.gov ↗ ← All trials in the Netherlands