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ALN-5288

Phase 1

Alzheimer's Disease | Small molecule | Neurology |Alnylam Pharmaceuticals, Inc.|Last Updated: Aug 14, 2026

Target and mechanism

Molecular targetMAPT
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

ALN-5288 · 1 trial · 1 indication

Phase 1 1
NCT07214727A Study to Evaluate ALN-5288 in Patients With Alzheimer's DiseaseAlzheimer's Disease
RECRUITING50 Analytics
PHASE1RECRUITING
A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Frequency of Adverse Events (AEs)
Up to 32 months
Severity of AEs
Up to 32 months

Secondary Endpoints

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
Concentration of ALN-5288 in Plasma Over Time (Ct)
Up to 32 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ALN-5288EXPERIMENTALParticipants will be administered ALN-5288 in the Double-blind (DB) Period and Open-Label Extension (OLE) Period.
Placebo + ALN-5288PLACEBO_COMPARATORParticipants will be administered placebo in the DB Period and ALN-5288 in the OLE Period.

Interventions

NameTypeDescription
ALN-5288DRUGALN-5288 will be administered IT.
PlaceboDRUGPlacebo will be administered IT.
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Eligibility Criteria

Age Range40 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites13

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 withi...

Countries:CanadaNetherlandsSpainUnited Kingdom
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Recent Changes (Last 90 Days)

LOWAug 14, 2026NCT07214727lastUpdatePostDate: changed
LOWAug 14, 2026NCT07214727lastUpdatePostDate: changed
LOWJul 24, 2026NCT07214727lastUpdatePostDate: changed
LOWJul 24, 2026NCT07214727lastUpdatePostDate: changed
LOWJun 12, 2026NCT07214727lastUpdatePostDate: changed
LOWJun 12, 2026NCT07214727lastUpdatePostDate: changed

Frequently asked questions about ALN-5288

What is ALN-5288 used for in Alzheimer's Disease?

ALN-5288 is an investigational small molecule being developed for the treatment of Alzheimer's Disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with Alzheimer's Disease to evaluate its safety and efficacy.

What does ALN-5288 target?

ALN-5288 targets MAPT, a protein involved in the pathology of Alzheimer's Disease. By targeting MAPT, the drug aims to address a key component of the disease process. This mechanism is being investigated in early-stage clinical trials to determine its potential therapeutic benefit.

Who is developing ALN-5288?

ALN-5288 is being developed by Alnylam Pharmaceuticals, Inc., a biopharmaceutical company. Alnylam is conducting clinical research on this investigational drug for Alzheimer's Disease. The company is listed on the stock exchange under the ticker symbol ALNY.

What phase is ALN-5288 in?

ALN-5288 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies. The Phase 1 trial is currently recruiting participants to evaluate the drug's safety, tolerability, and pharmacokinetics in patients with Alzheimer's Disease.

What clinical trials is ALN-5288 in?

ALN-5288 is being evaluated in a Phase 1 clinical trial registered as NCT07214727. This randomized, double-blind, placebo-controlled study is recruiting 50 participants with Alzheimer's Disease across Canada, Netherlands, Spain, and the United Kingdom. The trial is currently active and enrolling patients aged 40 years and older.

Is ALN-5288 the same as any other drug?

ALN-5288 is a distinct investigational compound developed by Alnylam Pharmaceuticals. It is not known to be marketed under any other name. The drug is being studied specifically for its potential role in treating Alzheimer's Disease and is currently in early-stage clinical trials.