Clinical Trials in Spain / NCT07214727
Recruiting
Phase 1
A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease
NCT07214727 · tracked via the Priya Life Science Spain 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 Spain
A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
Enrolling by invitation
Other trials for the same condition
A Study to Evaluate the Safety and Biomarker Effects of RO7269162 in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease (AD)
Active, not recruiting
Brain Characterization of Amyloid Protein and Glucose Metabolism of ALFA Project Participants
Recruiting
A Study of Remternetug (LY3372993) in Early Alzheimer's Disease (TRAILRUNNER-ALZ 3)
Active, not recruiting
Early Identification of Markers in Alzheimer's Families / ALFA
Active, not 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.
View NCT07214727 on ClinicalTrials.gov ↗ ← All trials in Spain