Recent Updates
Recently added Catalysts

ALN-5288

Phase 1

Alzheimer's Disease | Small molecule | Neurology |Alnylam Pharmaceuticals, Inc.|Last Updated: Jun 12, 2026

Success Probability
Subscribe to view
Market & Valuation
Subscribe to view
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 Disease
NCT0721472750
Unlock 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
Unlock Study Endpoints
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.
Unlock Study Design Details
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
Unlock Eligibility Criteria
Competitive Landscape -Alzheimer's Disease 66 trials

Top 20 of 25 competitors

CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY9PHASE3KarXT, KarX-EC
Eli Lilly and CompanyLLY12PHASE3Donanemab, Dexamethasone
Biogen Inc.BIIB2PHASE3Lecanemab
Annovis Bio IncANVS1PHASE3buntanetap/posiphen
ACADIA Pharmaceuticals Inc.ACAD2PHASE3ACP-204
Novartis AG Sponsored ADRNVS2PHASE2VHB937
GSK plc Sponsored ADRGSK2PHASE2GSK4527226
Cognition Therapeutics, Inc.CGTX2PHASE2CT1812
Johnson & JohnsonJNJ1PHASE2JNJ-64042056
Merck & Co., Inc.MRK1PHASE2MK-2214
Lantheus Holdings IncLNTH2PHASE3Nilotinib BE
Acumen Pharmaceuticals, Inc.ABOS1PHASE2sabirnetug
Aclaris Therapeutics, Inc.ACRS1PHASE2ATI-045
IGC Pharma, Inc.IGC1PHASE2IGC-AD1-Active
Alnylam Pharmaceuticals, IncALNY2PHASE1ALN-5288
Arrowhead Pharmaceuticals, Inc.ARWR1PHASE1ARO-MAPT-
AC Immune SAACIU2PHASE1ACI-24.060 at Dose A in Study Part 1a, ACI-24.060 at Dose B in Study Part 1a, ACI-24.060 at Dose C in Study Part 1a, ACI-24.060 with an additional adjuvant at Dose D in Study Part 1b, ACI-24.060 at Dose A in Study Part 2
Denali Therapeutics Inc.DNLI1PHASE1DNL628
Alzamend Neuro, Inc.ALZN1PHASE1ALZN002 .
Voyager Therapeutics, Inc.VYGR1PHASE1VY7523
Unlock Competitive Intelligence
Recent Changes (Last 90 Days)
LOWJun 12, 2026NCT07214727lastUpdatePostDate: changed
LOWJun 12, 2026NCT07214727lastUpdatePostDate: changed
LOWMay 26, 2026NCT07214727primaryCompletionDate: changed
LOWMay 24, 2026NCT07214727studyFirstPostDate: changed