A Study to Evaluate ALN-5288 in Patients With Alzheimer's... | NCT07214727

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

NCT07214727

Sponsor

Alnylam Pharmaceuticals

Status

Recruiting

Last Update Posted

Jun 12, 2026Actual

Enrollment

50Estimated

Phase

Phase 1

Conditions

Alzheimer's Disease

Interventions

ALN-5288
Placebo

Countries

Canada
Netherlands
Spain
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2025-522582-30-00	EU Trial (CTIS) Number

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2025Actual

Primary Completion Date

Mar 6, 2030Estimated

Completion Date

Mar 6, 2030Estimated

First Submitted Date

Oct 6, 2025

First Submission Date that Met QC Criteria

Oct 6, 2025

First Posted Date

Oct 9, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2026

Last Update Posted Date

Jun 12, 2026Actual

Name	Class
Regeneron Pharmaceuticals	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ALN-5288	Experimental	Participants will be administered ALN-5288 in the Double-blind (DB) Period and Open-Label Extension (OLE) Period.	Drug: ALN-5288
Placebo + ALN-5288	Placebo Comparator	Participants will be administered placebo in the DB Period and ALN-5288 in the OLE Period.	Drug: ALN-5288 Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ALN-5288	Drug	ALN-5288 will be administered IT.	ALN-5288 Placebo + ALN-5288

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of Adverse Events (AEs)		Up to 32 months
Severity of AEs		Up to 32 months

Secondary Outcomes

Measure	Description	Time Frame
Concentration of Total Tau (t-Tau) Protein in CSF Over Time		Up to 32 months
Change from Baseline in Concentration of t-Tau Protein in CSF Over Time		Up to 32 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Clinical Trial Information Line	Contact	1-877-ALNYLAM		clinicaltrials@alnylam.com
Clinical Trial Information Line	Contact	1-877-256-9526		clinicaltrials@alnylam.com

Overall Officials

Name	Affiliation	Role
Medical Director	Alnylam Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Trial Site	Recruiting	Montreal		H3G 1H9	Canada
Clinical Trial Site

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D000544	Alzheimer Disease
D003704	Dementia

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D024801	Tauopathies