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Clinical Trials in the UK / NCT07214727
Recruiting Phase 1

A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease

NCT07214727 · tracked via the Priya Life Science UK tracker
Sponsor
Alnylam Pharmaceuticals
Phase
Phase 1
Started
2025-10-15
Last updated
2026-09-14

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

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)

Trial sites (13)

FacilityCityRegionStatus
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.

View NCT07214727 on ClinicalTrials.gov ↗ ← All trials in the UK