Recruiting
Phase 1

ALN-5288

Sponsor:

Alnylam Pharmaceuticals

Code:

NCT07214727

Conditions

Alzheimer's Disease

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

ALN-5288

Placebo

Study Details

Brief 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

Conditions

Alzheimer's Disease

Study ID

NCT07214727

Start date

Oct 15, 2025

Status verified date

Aug, 2026

Completion date

Mar 6, 2030

Anticipated

Primary completion date

Mar 6, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ALN-5288

Participants will be administered ALN-5288 in the Double-blind (DB) Period and Open-Label Extension (OLE) Period.

placebo comparator: Placebo + ALN-5288

Participants will be administered placebo in the DB Period and ALN-5288 in the OLE Period.

Interventions

ALN-5288

ALN-5288 will be administered IT.

Placebo

Placebo will be administered IT.

Primary outcome measure

  • Frequency of Adverse Events (AEs) [ Time Frame: Up to 32 months ]
  • Severity of AEs [ Time Frame: Up to 32 months ]

Central Contacts and Locations

Central contacts

Clinical Trial Information Line

1-877-ALNYLAMclinicaltrials@alnylam.com

Clinical Trial Information Line

1-877-256-9526clinicaltrials@alnylam.com

Locations

Clinical Trial Site

Recruiting

Montreal, Canada, H3G 1H9

Clinical Trial Site

Recruiting

Ottawa, Canada, K1Z 1G3

Clinical Trial Site

Recruiting

Toronto, Canada, M3B 2S7

More Information

Sponsor

Alnylam Pharmaceuticals

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • AD
  • Dementia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alnylam Pharmaceuticals on 2026-08-14.