ALN-5288 injected into the spinal fluid for Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional study that delivers ALN-5288 into the cerebrospinal fluid (intrathecal) and compares it with placebo to characterize safety and tolerability. The trial will measure pharmacokinetic and pharmacodynamic effects in blood and CSF after dosing. Eligible participants must have AD confirmed by CSF biomarkers or a positive amyloid PET within seven years and have mild cognitive impairment or dementia due to AD. Study visits are conducted at clinical sites in Montreal, Ottawa, and Toronto.

Why it matters

Who can join: the full rules

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's running

• Clinical Trial Site
  Montreal, Canada Recruiting
• Clinical Trial Site
  Ottawa, Canada Recruiting
• Clinical Trial Site
  Toronto, Canada Recruiting
• Clinical Trial Site
  's-Hertogenbosch, Netherlands Recruiting
• Clinical Trial Site
  Amsterdam, Netherlands Recruiting
• Clinical Trial Site
  Madrid, Spain Recruiting

Study contacts

• Study coordinator: Clinical Trial Information Line
• Email: clinicaltrials@alnylam.com
• Phone: 1-877-ALNYLAM

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Acoustic Stimulation During Sleep for Alzheimer’s Disease

  Researchers test whether playing gentle sounds during sleep can help people with Alzheimer’s disease see if their thinking improves compared with a sham sound.

  Recruiting Xuanwu Hospital, Beijing · Beijing · NCT07924657

• FAME: A Italian test to recognize famous faces and name them

  This project tests an Italian battery to see how well people with stroke or neurodegenerative diseases recognize famous faces and recall their names, familiarity, and related facts.

  Recruiting at 8 sites Istituti Clinici Scientifici Maugeri SpA · Sciacca, AG and 9 other locations · NCT07911878

• NMS-01 safety test in people with mild to moderate Alzheimer's disease

  This pilot test checks whether the focused ultrasound device NMS-01 is safe and can briefly open the blood-brain barrier in adults with mild-to-moderate Alzheimer's disease.

  Recruiting Neumous Inc. · Seoul, Seodaemun · NCT07869238

• Choose Myself (Before) Losing Myself

  We’re testing an educational interactive booklet to help people with dementia or memory problems think about future medical decisions and start conversations with family or caregivers.

  Recruiting The Cleveland Clinic · Cleveland, Ohio · NCT07846566

• Lecanemab-irmb in Real-World Use for Alzheimer’s Disease

  This study tests the safety of lecanemab-irmb in people with Alzheimer’s disease by looking at real-world brain-image changes and related events.

  Recruiting Eisai Inc. · Nutley, New Jersey · NCT07821658

• Gut methane and Parkinson's: measuring if a probiotic helps people with Parkinson's, REM sleep behavior disorder, or cognitive concerns

  This study tests whether a probiotic containing Limosilactobacillus reuteri can help people with Parkinson's disease, those at high risk for PD, and related cognitive issues by potentially improving gut methane levels and overall symptoms.

  Recruiting University of Cambridge · Cambridge, CB2 · NCT07786116

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.