A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease
- 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 โฅ 20 points, CDR Global Score of 0.5 - 1.0, and RBANS score on the DMI โค95.
- 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
๐บ๐ธDelray Beach, Florida, United States
Georgetown University Medical Center
๐บ๐ธWashington, District of Columbia, United States
South Florida Neurology Associates
๐บ๐ธBoca Raton, Florida, United States
Charter Research
๐บ๐ธLady Lake, Florida, United States
K2 Medical Research
๐บ๐ธMaitland, Florida, United States
K2 Winter Garden Ocoee
๐บ๐ธOcoee, Florida, United States
Progressive Medical Research
๐บ๐ธPort Orange, Florida, United States
K2 The Villages
๐บ๐ธThe Villages, Florida, United States
Conquest Clinical Research (Winter Park)
๐บ๐ธWinter Park, Florida, United States
Hattiesburg Clinic
๐บ๐ธHattiesburg, Mississippi, United States
KaRa Institute of Neurological Disease
๐ฆ๐บMacquarie Park, New South Wales, Australia
Okanagan Clinical Trials
๐จ๐ฆKelowna, British Columbia, Canada
University Clinic Heidelberg
๐ฉ๐ชMannheim, Germany
Kawartha Regional Memory Clinic
๐จ๐ฆPeterborough, Ontario, Canada
Toronto Memory Clinic
๐จ๐ฆToronto, Ontario, Canada
Hรดpital Roger Salengro
๐ซ๐ทLille, Nord, France
Gerontopole
๐ซ๐ทToulouse, France
Charite Campus Buch
๐ฉ๐ชBerlin, Germany
Fondazione Policlinico Universitario A Gemelli
๐ฎ๐นRoma, Lazio, Italy
Azienda Policlinico Umberto I
๐ฎ๐นRoma, Lazio, Italy
Ospedale S Giovanni Calibita Fatebenefratelli
๐ฎ๐นRoma, Lazio, Italy
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
๐ฎ๐นBrescia, Italy
Fondazione IRCCS Cร Granda Ospedale Maggiore Policlinico
๐ฎ๐นMilano, Italy
Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta
๐ฎ๐นMilano, Italy
Ospedale Civile di Baggiovara
๐ฎ๐นModena, Italy
Ospedale degli Infermi
๐ฎ๐นPonderano, Italy
Brain Research Center Amsterdam
๐ณ๐ฑAmsterdam, Netherlands
CGM Research Trust
๐ณ๐ฟChristchurch, New Zealand
NZOZ Wroclawskie Centrum Alzheimerowskie
๐ต๐ฑWrocลaw, Dolnoslaskie, Poland
Centrum Medyczne NeuroProtect
๐ต๐ฑWarszawa, Mazowieckie, Poland
SOMED CR
๐ต๐ฑWarsaw, Poland
Hospital de La Santa Creu i Sant Pau
๐ช๐ธBarcelona, Cataluรฑa, Spain
Fundacion CITA Alzheimer Fundazioa
๐ช๐ธDonostia, Guipuzcoa, Spain
Centro de Atencion Especializada Oroitu
๐ช๐ธGetxo, Pais Vasco, Spain
Fundacion ACE Instituto Catalan de Neurociencias
๐ช๐ธBarcelona, Spain
Hospital Clinic de Barcelona
๐ช๐ธBarcelona, Spain
Hospital Universitario Ramon y Cajal
๐ช๐ธMadrid, Spain
Hospital Universitario Doctor Peset
๐ช๐ธValencia, Spain
Hospital Universitari i Politecnic La Fe de Valencia
๐ช๐ธValencia, Spain
Hospital Viamed Montecanal
๐ช๐ธZaragoza, Spain
The National Hospital for Neurology and Neurosurgery
๐ฌ๐งLondon, United Kingdom
Glasgow Memory Clinic
๐ฌ๐งMotherwell, United Kingdom
Re:Cognition Health Plymouth
๐ฌ๐งPlymouth, United Kingdom
SMarT Minds WA
๐ฆ๐บNedlands, Western Australia, Australia
ATP Clinical Research
๐บ๐ธCosta Mesa, California, United States
AMITA Health Clinical Research Institute
๐บ๐ธElk Grove Village, Illinois, United States
Feinstein Institute For MR
๐บ๐ธManhasset, New York, United States
Columbia University College of Physicians and Surgeons
๐บ๐ธNew York, New York, United States
University of Rochester Medical Center
๐บ๐ธRochester, New York, United States
Abington Neurologic Associates
๐บ๐ธAbington, Pennsylvania, United States
SUNY Upstate Medical Center
๐บ๐ธSyracuse, New York, United States
LMU Klinikum der Universitรคt Mรผnchen
๐ฉ๐ชMรผnchen, Germany
Woodlands Research Network, LLC - ERG
๐บ๐ธRogers, Arkansas, United States
ClinCloud, LLC
๐บ๐ธMaitland, Florida, United States
The Alfred Hospital
๐ฆ๐บParkville, Victoria, Australia
Centro de Psiquiatrรญa Biolรณgica Instituto Senecta
๐ฆ๐ทMendoza, Argentina
Parkwood Institute
๐จ๐ฆLondon, Ontario, Canada
Box Hill Hospital
๐ฆ๐บBox Hill, Victoria, Australia
Alzheimers Research and Treatment Center
๐บ๐ธWellington, Florida, United States
Boston Center for Memory
๐บ๐ธNewton, Massachusetts, United States
Charitรฉ - Universitรคtsmedizin Berlin (CBF)
๐ฉ๐ชBerlin, Germany
Hรดpital de la Pitiรฉ Salpรฉtriรจre
๐ซ๐ทParis, France
Advanced Clinical Institute
๐บ๐ธNeptune, New Jersey, United States
Instituto Kremer
๐ฆ๐ทCรณrdoba, Argentina
Universitรคtsklinikum Ulm
๐ฉ๐ชUlm, Germany
EUROMEDIS Sp. z o.o.
๐ต๐ฑSzczecin, Zachodniopomorskie, Poland
True North Clinical Research - New Minas
๐จ๐ฆNew Minas, Nova Scotia, Canada
True North Clinical Research - Halifax
๐จ๐ฆHalifax, Nova Scotia, Canada
Brain Research Center Den Bosch
๐ณ๐ฑ's-Hertogenbosch, Noord-Brabant, Netherlands
Baycrest Health Sciences
๐จ๐ฆToronto, Ontario, Canada
University of Kentucky
๐บ๐ธLexington, Kentucky, United States
Bruyรจre Research Institute
๐จ๐ฆOttawa, Ontario, Canada
Hopital Lariboisiere
๐ซ๐ทParis, France
Centre Hospitalier Universitaire de Toulouse
๐ซ๐ทToulouse, France
Klinikum rechts der Isa der Technischen Universitaet Muenchen
๐ฉ๐ชMรผnchen, Germany
IRCCS - Centro S. Giovanni di Dio Fatebenefratelli
๐ฎ๐นBrescia, Lombardia, Italy
Azienda Ospedaliero Universitaria Pisana
๐ฎ๐นPisa, Italy
Re: Cognition Health - Guildford
๐ฌ๐งGuildford, Surrey, United Kingdom
Banner Alzheimer's Institute
๐บ๐ธPhoenix, Arizona, United States
Emory University
๐บ๐ธAtlanta, Georgia, United States
University of Cincinnati MC
๐บ๐ธCincinnati, Ohio, United States
Clinical Trial Network
๐บ๐ธHouston, Texas, United States
Summit Research Network
๐บ๐ธPortland, Oregon, United States
Re:Cognition Health London
๐ฌ๐งLondon, United Kingdom
Re:Cognition Health Bristol
๐ฌ๐งBristol, United Kingdom
Axiom Clinical Research FL
๐บ๐ธTampa, Florida, United States
Greater Manchester Mental Health NHS Foundation Trust
๐ฌ๐งManchester, United Kingdom