A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease
- Conditions
- Alzheimer Disease
- Interventions
- Drug: AL002Drug: Placebo
- Registration Number
- NCT04592874
- Lead Sponsor
- Alector Inc.
- Brief Summary
A phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 in participants with Early Alzheimer's Disease.
- Detailed Description
This is a phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 administered intravenously in participants with Early Alzheimer's Disease.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 328
- 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 week
- Written informed consent must be obtained and documented (from the participant or, where jurisdictions allow it, from their legal decision maker).
- Dementia due to a condition other than AD including, but not limited to, FTD, Parkinson's disease, dementia with Lewy bodies, Huntington disease, or vascular dementia. - Dementia due to a condition other than AD including, but not limited to, FTD, Parkinson's disease, dementia with Lewy bodies, Huntington disease, or vascular dementia.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AL002 Dose 2 AL002 AL002 every 4 weeks Placebo Placebo Placebo every 4 weeks AL002 Dose 1 AL002 AL002 every 4 weeks AL002 Dose 3 AL002 AL002 every 4 weeks
- Primary Outcome Measures
Name Time Method Disease progression as measured by the CDR-SB Through study completion, up to 48 through 96 weeks
- Secondary Outcome Measures
Name Time Method Change in RBANS score Through study completion, up to 48 through 96 weeks Change in ADAS-Cog13 score Through study completion, up to 48 through 96 weeks Change in ADCS-ADL-MCI score Through study completion, up to 48 through 96 weeks Change in ADCOMS score Through study completion, up to 48 through 96 weeks Evaluation of safety and tolerability of AL002: Incidence of adverse events Through study completion, up to 48 through 96 weeks Incidence of adverse events
Change in MMSE score Through study completion, up to 48 through 96 weeks
Trial Locations
- Locations (87)
Brain Matters Research - ERG
🇺🇸Delray Beach, Florida, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
South Florida Neurology Associates
🇺🇸Boca Raton, Florida, United States
Charter Research
🇺🇸Lady Lake, 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
K2 The Villages
🇺🇸The Villages, Florida, United States
Conquest Clinical Research (Winter Park)
🇺🇸Winter Park, Florida, United States
Hattiesburg Clinic
🇺🇸Hattiesburg, Mississippi, United States
KaRa Institute of Neurological Disease
🇦🇺Macquarie Park, New South Wales, Australia
Okanagan Clinical Trials
🇨🇦Kelowna, British Columbia, Canada
University Clinic Heidelberg
🇩🇪Mannheim, Germany
Kawartha Regional Memory Clinic
🇨🇦Peterborough, Ontario, Canada
Toronto Memory Clinic
🇨🇦Toronto, Ontario, Canada
Hôpital Roger Salengro
🇫🇷Lille, Nord, France
Gerontopole
🇫🇷Toulouse, France
Charite Campus Buch
🇩🇪Berlin, Germany
Fondazione Policlinico Universitario A Gemelli
🇮🇹Roma, Lazio, Italy
Azienda Policlinico Umberto I
🇮🇹Roma, Lazio, Italy
Ospedale S Giovanni Calibita Fatebenefratelli
🇮🇹Roma, Lazio, Italy
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
🇮🇹Brescia, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta
🇮🇹Milano, Italy
Ospedale Civile di Baggiovara
🇮🇹Modena, Italy
Ospedale degli Infermi
🇮🇹Ponderano, Italy
Brain Research Center Amsterdam
🇳🇱Amsterdam, Netherlands
CGM Research Trust
🇳🇿Christchurch, New Zealand
NZOZ Wroclawskie Centrum Alzheimerowskie
🇵🇱Wrocław, Dolnoslaskie, Poland
Centrum Medyczne NeuroProtect
🇵🇱Warszawa, Mazowieckie, Poland
SOMED CR
🇵🇱Warsaw, Poland
Hospital de La Santa Creu i Sant Pau
🇪🇸Barcelona, Cataluña, Spain
Fundacion CITA Alzheimer Fundazioa
🇪🇸Donostia, Guipuzcoa, Spain
Centro de Atencion Especializada Oroitu
🇪🇸Getxo, Pais Vasco, 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
The National Hospital for Neurology and Neurosurgery
🇬🇧London, United Kingdom
Glasgow Memory Clinic
🇬🇧Motherwell, United Kingdom
Re:Cognition Health Plymouth
🇬🇧Plymouth, United Kingdom
SMarT Minds WA
🇦🇺Nedlands, Western Australia, Australia
ATP Clinical Research
🇺🇸Costa Mesa, California, United States
AMITA Health Clinical Research Institute
🇺🇸Elk Grove Village, Illinois, 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
Abington Neurologic Associates
🇺🇸Abington, Pennsylvania, United States
SUNY Upstate Medical Center
🇺🇸Syracuse, New York, United States
LMU Klinikum der Universität München
🇩🇪München, Germany
Woodlands Research Network, LLC - ERG
🇺🇸Rogers, Arkansas, United States
ClinCloud, LLC
🇺🇸Maitland, Florida, United States
The Alfred Hospital
🇦🇺Parkville, Victoria, Australia
Centro de Psiquiatría Biológica Instituto Senecta
🇦🇷Mendoza, Argentina
Parkwood Institute
🇨🇦London, Ontario, Canada
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Alzheimers Research and Treatment Center
🇺🇸Wellington, Florida, United States
Boston Center for Memory
🇺🇸Newton, Massachusetts, United States
Charité - Universitätsmedizin Berlin (CBF)
🇩🇪Berlin, Germany
Hôpital de la Pitié Salpétrière
🇫🇷Paris, France
Advanced Clinical Institute
🇺🇸Neptune, New Jersey, United States
Instituto Kremer
🇦🇷Córdoba, Argentina
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
EUROMEDIS Sp. z o.o.
🇵🇱Szczecin, Zachodniopomorskie, Poland
True North Clinical Research - New Minas
🇨🇦New Minas, Nova Scotia, Canada
True North Clinical Research - Halifax
🇨🇦Halifax, Nova Scotia, Canada
Brain Research Center Den Bosch
🇳🇱's-Hertogenbosch, Noord-Brabant, Netherlands
Baycrest Health Sciences
🇨🇦Toronto, Ontario, Canada
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Bruyère Research Institute
🇨🇦Ottawa, Ontario, Canada
Hopital Lariboisiere
🇫🇷Paris, France
Centre Hospitalier Universitaire de Toulouse
🇫🇷Toulouse, France
Klinikum rechts der Isa der Technischen Universitaet Muenchen
🇩🇪München, Germany
IRCCS - Centro S. Giovanni di Dio Fatebenefratelli
🇮🇹Brescia, Lombardia, Italy
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Italy
Re: Cognition Health - Guildford
🇬🇧Guildford, Surrey, United Kingdom
Banner Alzheimer's Institute
🇺🇸Phoenix, Arizona, United States
Emory University
🇺🇸Atlanta, Georgia, United States
University of Cincinnati MC
🇺🇸Cincinnati, Ohio, United States
Clinical Trial Network
🇺🇸Houston, Texas, United States
Summit Research Network
🇺🇸Portland, Oregon, United States
Re:Cognition Health London
🇬🇧London, United Kingdom
Re:Cognition Health Bristol
🇬🇧Bristol, United Kingdom
Axiom Clinical Research FL
🇺🇸Tampa, Florida, United States
Greater Manchester Mental Health NHS Foundation Trust
🇬🇧Manchester, United Kingdom
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