A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease
NCT ID: NCT04592874
Last Updated: 2025-10-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
356 participants
INTERVENTIONAL
2021-01-22
2024-09-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AL002 Dose 1
AL002 every 4 weeks
AL002
Administered via intravenous (IV) infusion
AL002 Dose 2
AL002 every 4 weeks
AL002
Administered via intravenous (IV) infusion
AL002 Dose 3
AL002 every 4 weeks
AL002
Administered via intravenous (IV) infusion
Placebo
Placebo every 4 weeks
Placebo
Administered via intravenous (IV) infusion
Interventions
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AL002
Administered via intravenous (IV) infusion
Placebo
Administered via intravenous (IV) infusion
Eligibility Criteria
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Inclusion Criteria
* 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 week
* Written informed consent must be obtained and documented (from the participant or, where jurisdictions allow it, from their legal decision maker).
Exclusion Criteria
* Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
* Current uncontrolled hypertension, diabetes mellitus or thyroid disease. Clinically significant heart disease, liver disease or kidney disease.
* History or evidence of clinically significant brain disease other than AD.
* Females who are pregnant or breastfeeding, or planning to conceive within the study period.
* Any experimental vaccine or gene therapy.
* History of unresolved cancer.
* Current use of anticoagulant medications.
* Residence in a skilled nursing facility, convalescent home, or long term care facility at screening; or requires continuous nursing care.
* Participant is positive for presence of APOE e4/e4 genotype.
50 Years
85 Years
ALL
No
Sponsors
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Alector Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Catherine Mummery
Role: PRINCIPAL_INVESTIGATOR
Locations
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Banner Alzheimer's Institute
Phoenix, Arizona, United States
Woodlands Research Network, LLC - ERG
Rogers, Arkansas, United States
ATP Clinical Research
Costa Mesa, California, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
South Florida Neurology Associates
Boca Raton, Florida, United States
Brain Matters Research - ERG
Delray Beach, Florida, United States
Charter Research
Lady Lake, Florida, United States
ClinCloud, LLC
Maitland, Florida, United States
K2 Medical Research
Maitland, Florida, United States
K2 Winter Garden Ocoee
Ocoee, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Axiom Clinical Research FL
Tampa, Florida, United States
K2 The Villages
The Villages, Florida, United States
Alzheimers Research and Treatment Center
Wellington, Florida, United States
Conquest Clinical Research (Winter Park)
Winter Park, Florida, United States
Emory University
Atlanta, Georgia, United States
AMITA Health Clinical Research Institute
Elk Grove Village, Illinois, United States
University of Kentucky
Lexington, Kentucky, United States
Boston Center for Memory
Newton, Massachusetts, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Advanced Clinical Institute
Neptune City, New Jersey, United States
Feinstein Institute For MR
Manhasset, New York, United States
Columbia University College of Physicians and Surgeons
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
SUNY Upstate Medical Center
Syracuse, New York, United States
University of Cincinnati MC
Cincinnati, Ohio, United States
Summit Research Network
Portland, Oregon, United States
Abington Neurologic Associates
Abington, Pennsylvania, United States
Clinical Trial Network
Houston, Texas, United States
Instituto Kremer
Córdoba, , Argentina
Centro de Psiquiatría Biológica Instituto Senecta
Mendoza, , Argentina
KaRa Institute of Neurological Disease
Macquarie Park, New South Wales, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
The Alfred Hospital
Parkville, Victoria, Australia
SMarT Minds WA
Nedlands, Western Australia, Australia
Okanagan Clinical Trials
Kelowna, British Columbia, Canada
True North Clinical Research - Halifax
Halifax, Nova Scotia, Canada
True North Clinical Research - New Minas
New Minas, Nova Scotia, Canada
Parkwood Institute
London, Ontario, Canada
Bruyère Research Institute
Ottawa, Ontario, Canada
Kawartha Regional Memory Clinic
Peterborough, Ontario, Canada
Toronto Memory Clinic
Toronto, Ontario, Canada
Baycrest Health Sciences
Toronto, Ontario, Canada
Hôpital Roger Salengro
Lille, Nord, France
Hopital Lariboisiere
Paris, , France
Hôpital de la Pitié Salpétrière
Paris, , France
Centre Hospitalier Universitaire de Toulouse
Toulouse, , France
Gerontopole
Toulouse, , France
Charité - Universitätsmedizin Berlin (CBF)
Berlin, , Germany
Charite Campus Buch
Berlin, , Germany
University Clinic Heidelberg
Mannheim, , Germany
LMU Klinikum der Universität München
München, , Germany
Klinikum rechts der Isa der Technischen Universitaet Muenchen
München, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Fondazione Policlinico Universitario A Gemelli
Rome, Lazio, Italy
Azienda Policlinico Umberto I
Rome, Lazio, Italy
Ospedale S Giovanni Calibita Fatebenefratelli
Rome, Lazio, Italy
IRCCS - Centro S. Giovanni di Dio Fatebenefratelli
Brescia, Lombardy, Italy
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
Brescia, , Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, , Italy
Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta
Milan, , Italy
Ospedale Civile di Baggiovara
Modena, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Ospedale degli Infermi
Ponderano, , Italy
Brain Research Center Den Bosch
's-Hertogenbosch, North Brabant, Netherlands
Brain Research Center Amsterdam
Amsterdam, , Netherlands
CGM Research Trust
Christchurch, , New Zealand
NZOZ Wroclawskie Centrum Alzheimerowskie
Wroclaw, Lower Silesian Voivodeship, Poland
Centrum Medyczne NeuroProtect
Warsaw, Masovian Voivodeship, Poland
EUROMEDIS Sp. z o.o.
Szczecin, West Pomeranian Voivodeship, Poland
SOMED CR
Warsaw, , Poland
Centro de Atencion Especializada Oroitu
Getxo, Basque Country, Spain
Hospital de La Santa Creu i Sant Pau
Barcelona, Catalonia, Spain
Fundacion CITA Alzheimer Fundazioa
Donostia / San Sebastian, Guipuzcoa, Spain
Fundacion ACE Instituto Catalan de Neurociencias
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario Doctor Peset
Valencia, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Hospital Viamed Montecanal
Zaragoza, , Spain
Re: Cognition Health - Guildford
Guildford, Surrey, United Kingdom
Re:Cognition Health Bristol
Bristol, , United Kingdom
Re:Cognition Health London
London, , United Kingdom
The National Hospital for Neurology and Neurosurgery
London, , United Kingdom
Greater Manchester Mental Health NHS Foundation Trust
Manchester, , United Kingdom
Glasgow Memory Clinic
Motherwell, , United Kingdom
Re:Cognition Health Plymouth
Plymouth, , United Kingdom
Countries
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References
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Shao Q, Chen S, Zheng Y, Xu W, Chen J, Shao W, Wang Q, Li C, Wang X. Crucial role of microglia-mediated myelin sheath damage in vascular dementia: Antecedents and consequences. Neural Regen Res. 2026 Mar 1;21(3):1000-1012. doi: 10.4103/NRR.NRR-D-24-01109. Epub 2025 Mar 25.
Brodtmann A, Darby D, Oboudiyat C, Mahoney CJ, Le Heron C, Panegyres PK, Brew B. Assessing preparedness for Alzheimer disease-modifying therapies in Australasian health care systems. Med J Aust. 2023 Apr 3;218(6):247-249. doi: 10.5694/mja2.51880. Epub 2023 Mar 19. No abstract available.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AL002-2
Identifier Type: -
Identifier Source: org_study_id
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