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AL002

Phase 2

Alzheimer Disease | Small molecule | Neurology |Alector, Inc.|Last Updated: Oct 29, 2025

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment356

FDA Designations

No designations recorded

Clinical trial landscape

AL002 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT04592874A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's DiseaseAlzheimer Disease
COMPLETED356 Analytics
PHASE2COMPLETED
A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease
Alzheimer DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
Study completion up to 96 weeks

Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) score at Weeks 24, 48, 72 and 96. The CDR-SB is a tool used to measure disease severity in Alzheimer's disease. This scale assesses three domains of cognition and three domains of function. The domains are rated on a 5 point scale in which the higher the score corresponds to greater cognitive impairment. The scale range is from 0 to 18 where 0 is considered normal and 18 indicates severe dementia.

Evaluation of safety and tolerability of AL002 measured by number of subjects with adverse events and Dose Limiting Adverse Event (DLAEs)
141 days

Incidence of adverse events and dose limiting Adverse Events during the DLAE observation period and/or study treatment periods.

Secondary Endpoints

Change in Mini-Mental Status Examination (MMSE) Score
Study completion up to 96 weeks
Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score
Study completion up to 96 weeks
Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score
Study completion up to 96 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AL002 Dose 1EXPERIMENTALAL002 every 4 weeks
AL002 Dose 2EXPERIMENTALAL002 every 4 weeks
AL002 Dose 3EXPERIMENTALAL002 every 4 weeks
PlaceboPLACEBO_COMPARATORPlacebo every 4 weeks
AL002ACTIVE_COMPARATORAL002 by intravenous (IV) infusion
Saline SolutionPLACEBO_COMPARATORplacebo by intravenous (IV) infusion

Interventions

NameTypeDescription
AL002DRUGAdministered via intravenous (IV) infusion
PlaceboDRUGAdministered via intravenous (IV) infusion
Saline SolutionOTHERSaline solution will be administered as a single infusion for each cohort in a ratio of 6 active and 2 placebo subjects for HV and 10 active and 2 placebo for patients
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Eligibility Criteria

Age Range50 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites87

Inclusion Criteria: * Diagnosis of Early AD including evidence of brain amyloidosis by CSF or PET * MMSE score ≥ 20 points, CDR Global Score of 0.5 - 1.0, and RBANS score on the DMI ≤95. * Study partner who consents to study participation and who cares for/visits the participant at least 10 hours a...

Countries:United StatesArgentinaAustraliaCanadaFranceGermanyItalyNetherlandsNew ZealandPolandSpainUnited Kingdom
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Frequently asked questions about AL002

What is AL002 used for?

AL002 is an investigational small molecule being studied for the treatment of Alzheimer's disease. It has been evaluated in clinical trials involving participants with early Alzheimer's disease, as well as in healthy volunteers. The drug is being developed by Alector, Inc. and is currently in Phase 2 clinical development.

What does AL002 target?

AL002 is a small molecule developed by Alector, Inc. for the treatment of Alzheimer's disease. The specific molecular target of AL002 has not been disclosed in available clinical trial information. The drug is being investigated for its potential to modify the course of early Alzheimer's disease.

Who makes AL002?

AL002 is being developed by Alector, Inc., a biopharmaceutical company focused on immunology and neurology. Alector is publicly traded under the ticker symbol ALEC. The company is conducting clinical trials to evaluate AL002 as a potential treatment for Alzheimer's disease.

What phase is AL002 in?

AL002 is currently in Phase 2 clinical development for the treatment of early Alzheimer's disease. A Phase 2 study has been completed, evaluating the efficacy and safety of AL002 in participants with early Alzheimer's disease. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is AL002 in?

AL002 has been studied in two clinical trials. A Phase 1 study (NCT03635047) assessed safety and tolerability in healthy volunteers and participants with Alzheimer's disease. A Phase 2 study (NCT04592874) evaluated efficacy and safety in 356 participants with early Alzheimer's disease. Both trials have been completed.

Is AL002 the same as other Alzheimer's treatments?

AL002 is a distinct investigational small molecule developed by Alector, Inc. for Alzheimer's disease. It is not known to be the same as any other marketed or investigational Alzheimer's drug. Its mechanism of action and clinical profile are being evaluated in ongoing research.