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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-15

Study Completion Date

2030-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Alzheimer's Disease

Keywords

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AD Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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ALN-5288

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

Group Type EXPERIMENTAL

ALN-5288

Intervention Type DRUG

ALN-5288 will be administered IT.

Placebo + ALN-5288

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

Group Type PLACEBO_COMPARATOR

ALN-5288

Intervention Type DRUG

ALN-5288 will be administered IT.

Placebo

Intervention Type DRUG

Placebo will be administered IT.

Interventions

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ALN-5288

ALN-5288 will be administered IT.

Intervention Type DRUG

Placebo

Placebo will be administered IT.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Alnylam Pharmaceuticals Inc

Locations

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