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NCT07214727RecruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 8 Oct 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
50 (estimated)
First submitted
6 Oct 2025
Start date
15 Oct 2025
Primary completion date
6 Mar 2030
Lead sponsor
Alnylam Pharmaceuticals
NCT number
NCT07214727
EU CT number
2025-522582-30-00

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 50
  • From 15 Oct 2025 to the primary completion date, 6 Mar 2030
  • 13 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has history of uncontrolled seizures within the last 6 months prior to Screening

Other illness

  • Has non-AD dementia
  • Has known human immunodeficiency virus infection
  • Has history of hepatitis C virus or current hepatitis B virus infection
  • 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

Lab values

  • Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2× upper limit of normal (ULN)
  • Has total bilirubin \>1.5×ULN
  • Has an estimated glomerular filtration (eGFR) of \<45 mL/min/1.73 m\^2 at screening

Other

  • Has systolic blood pressure \>160 mmHg and/or a diastolic blood pressure \>100 mmHg after 10 minutes of rest at screening
  • Has clinically significant ECG abnormalities at screening

Who the study is looking for

  • 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

Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Clinical Trial Site
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MontrealCanadaRecruiting
Clinical Trial Site
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OttawaCanadaRecruiting
Clinical Trial Site
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TorontoCanadaRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital Clínico San Carlos
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MadridSpainRecruiting
Hospital Universitari General de Catalunya
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Sant Cugat del VallèsSpainRecruiting
Clinical Trial Site
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GlasgowUnited KingdomRecruiting
Clinical Trial Site
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LondonUnited KingdomRecruiting
Clinical Trial Site
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SheffieldUnited KingdomRecruiting
Clinical Trial Site
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SouthamptonUnited KingdomRecruiting
Brain Research Center Amsterdam B.V.
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AmsterdamNetherlandsRecruiting
Amsterdam UMC Stichting
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AmsterdamNetherlandsRecruiting
Brain Research Center Den Bosch B.V.
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's-HertogenboschNetherlandsRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.