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

NCT ID: NCT07214727
Registry status: Recruiting
Study type: Interventional
Phase: Phase 1
Sponsor: Alnylam Pharmaceuticals
Conditions: Alzheimer's Disease

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: 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

Enrollment: 50 participants (Estimated).

What is being studied

Drug: ALN-5288
Drug: Placebo

Who may be eligible

Ages: 40 Years to 80 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

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

Study locations

12 study locations are listed.

Recruiting site status is explicitly provided for 12 locations; 10 are listed as Recruiting.

Countries: Canada, Netherlands, Spain, United Kingdom

Sample of listed locations

Clinical Trial Site — Montreal, H3G 1H9, Canada — Recruiting
Clinical Trial Site — Ottawa, K1Z 1G3, Canada — Recruiting
Clinical Trial Site — Toronto, M3B 2S7, Canada — Recruiting
Clinical Trial Site — 's-Hertogenbosch, 5223, Netherlands — Recruiting
Clinical Trial Site — Amsterdam, 1081 GN, Netherlands — Recruiting
Clinical Trial Site — Madrid, 28040, Spain — Recruiting
Clinical Trial Site — Glasgow, G51 4TF, United Kingdom — Recruiting
Clinical Trial Site — London, WC1N 3BG, United Kingdom — Recruiting
Clinical Trial Site — Sheffield, S10 2JF, United Kingdom — Recruiting
Clinical Trial Site — Southampton, SO16 6YD, United Kingdom — Recruiting
Clinical Trial Site — Barcelona, 08036, Spain — Not yet recruiting
Clinical Trial Site — Sant Cugat del Vallès, 08190, Spain — Not yet recruiting

Study details

Start date: October 15, 2025
Primary completion date: March 6, 2030
Completion date: March 6, 2030
First posted: October 9, 2025
Collaborators: Regeneron Pharmaceuticals

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT07214727
Registry last updated: October 8, 2026
QualifiedStudies registry data refreshed: October 12, 2026
QualifiedStudies record fetched: October 12, 2026

View NCT07214727 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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