RecruitingPhase 1NCT07214727

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

A Phase 1, Randomized, Placebo-controlled Study With a Double Blind Period With Open-label Extension Period to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ALN-5288 in Adult Patients With Alzheimer's Disease


Sponsor

Alnylam Pharmaceuticals

Enrollment

50 participants

Start Date

Oct 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called ALN-5288 in people with Alzheimer's disease. The drug is given by injection into the spinal fluid (intrathecally) and aims to slow or modify the disease process. **You may be eligible if...** - You have a confirmed diagnosis of Alzheimer's disease, supported by spinal fluid tests or a brain scan showing amyloid plaques (within the last 7 years) - You have mild memory impairment or mild to moderate dementia due to Alzheimer's disease - Your doctor believes you are physically and mentally able to complete the study **You may NOT be eligible if...** - Your dementia is caused by something other than Alzheimer's disease - You have significantly abnormal liver or kidney function - You have uncontrolled high blood pressure, active HIV, or hepatitis B/C infection - You have a bleeding disorder or history of uncontrolled seizures in the last 6 months - You have a brain or spine condition that would make the injection procedure unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGALN-5288

ALN-5288 will be administered IT.

DRUGPlacebo

Placebo will be administered IT.


Locations(11)

Clinical Trial Site

Montreal, Canada

Clinical Trial Site

Ottawa, Canada

Clinical Trial Site

Toronto, Canada

Clinical Trial Site

Toronto, Canada

Clinical Trial Site

's-Hertogenbosch, Netherlands

Clinical Trial Site

Barcelona, Spain

Clinical Trial Site

Madrid, Spain

Clinical Trial Site

Glasgow, United Kingdom

Clinical Trial Site

London, United Kingdom

Clinical Trial Site

Sheffield, United Kingdom

Clinical Trial Site

Southampton, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07214727


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