Clinical trial NCT04592874: A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease
Lead sponsor: Alector Inc.
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2020-10-19
Enrollment: 381
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 week
* Written informed consent must be obtained and documented (from the participant or, where jurisdictions allow it, from their legal decision maker).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Disease progression as measured by the CDR-SB
timeFrame: Through study completion, up to 48 through 96 weeks
Secondary outcomes:
measure: Change in MMSE score
timeFrame: Through study completion, up to 48 through 96 weeks
measure: Change in RBANS score
timeFrame: Through study completion, up to 48 through 96 weeks
measure: Change in ADAS-Cog13 score
timeFrame: Through study completion, up to 48 through 96 weeks
measure: Change in ADCS-ADL-MCI score
timeFrame: Through study completion, up to 48 through 96 weeks
measure: Change in ADCOMS score
timeFrame: Through study completion, up to 48 through 96 weeks
measure: Evaluation of safety and tolerability of AL002: Incidence of adverse events
timeFrame: Through study completion, up to 48 through 96 weeks
Other outcomes:
measure: Change in brain volume as assessed by magnetic resonance imaging
timeFrame: Through study completion, up to 48 through 96 weeks
measure: Change in blood based biomarkers
timeFrame: Through study completion, up to 48 through 96 weeks
measure: Change in CSF biomarkers (optional)
timeFrame: Through study completion, up to 48 through 96 weeks
measure: Change in amyloid burden as assessed by positron emission tomography imaging (optional)
timeFrame: Through study completion, up to 48 through 96 weeks
measure: Change in tau tangles as assessed by positron emission tomography imaging (optional)
timeFrame: Through study completion, up to 48 through 96 weeks
measure: Change in Winterlight Language Speech Assessment score (optional)
timeFrame: Through study completion, up to 48 through 96 weeks
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Rogers
country: United States
facility: Woodlands Research Network, LLC - ERG
state: Arkansas
city: Costa Mesa
country: United States
facility: ATP Clinical Research
state: California
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Boca Raton
country: United States
facility: South Florida Neurology Associates
state: Florida
city: Delray Beach
country: United States
facility: Brain Matters Research - ERG
state: Florida
city: Lady Lake
country: United States
facility: Charter Research
state: Florida
city: Maitland
country: United States
facility: ClinCloud, LLC
state: Florida
city: Maitland
country: United States
facility: K2 Medical Research
state: Florida
city: Ocoee
country: United States
facility: K2 Winter Garden Ocoee
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Tampa
country: United States
facility: Axiom Clinical Research FL
state: Florida
city: The Villages
country: United States
facility: K2 The Villages
state: Florida
city: Wellington
country: United States
facility: Alzheimers Research and Treatment Center
state: Florida
city: Winter Park
country: United States
facility: Conquest Clinical Research (Winter Park)
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Elk Grove Village
country: United States
facility: AMITA Health Clinical Research Institute
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Newton
country: United States
facility: Boston Center for Memory
state: Massachusetts
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic
state: Mississippi
city: Neptune
country: United States
facility: Advanced Clinical Institute
state: New Jersey
city: Manhasset
country: United States
facility: Feinstein Institute For MR
state: New York
city: New York
country: United States
facility: Columbia University College of Physicians and Surgeons
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical Center
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati MC
state: Ohio
city: Portland
country: United States
facility: Summit Research Network
state: Oregon
city: Abington
country: United States
facility: Abington Neurologic Associates
state: Pennsylvania
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Córdoba
country: Argentina
facility: Instituto Kremer
city: Mendoza
country: Argentina
facility: Centro de Psiquiatría Biológica Instituto Senecta
city: Macquarie Park
country: Australia
facility: KaRa Institute of Neurological Disease
state: New South Wales
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Parkville
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Nedlands
country: Australia
facility: SMarT Minds WA
state: Western Australia
city: Kelowna
country: Canada
facility: Okanagan Clinical Trials
state: British Columbia
city: Halifax
country: Canada
facility: True North Clinical Research - Halifax
state: Nova Scotia
city: New Minas
country: Canada
facility: True North Clinical Research - New Minas
state: Nova Scotia
city: London
country: Canada
facility: Parkwood Institute
state: Ontario
city: Ottawa
country: Canada
facility: Bruyère Research Institute
state: Ontario
city: Peterborough
country: Canada
facility: Kawartha Regional Memory Clinic
state: Ontario
city: Toronto
country: Canada
facility: Toronto Memory Clinic
state: Ontario
city: Toronto
country: Canada
facility: Baycrest Health Sciences
state: Ontario
city: Lille
country: France
facility: Hôpital Roger Salengro
state: Nord
city: Paris
country: France
facility: Hopital Lariboisiere
city: Paris
country: France
facility: Hôpital de la Pitié Salpétrière
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse
city: Toulouse
country: France
facility: Gerontopole
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin (CBF)
city: Berlin
country: Germany
facility: Charite Campus Buch
city: Mannheim
country: Germany
facility: University Clinic Heidelberg
city: München
country: Germany
facility: LMU Klinikum der Universität München
city: München
country: Germany
facility: Klinikum rechts der Isa der Technischen Universitaet Muenchen
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A Gemelli
state: Lazio
city: Roma
country: Italy
facility: Azienda Policlinico Umberto I
state: Lazio
city: Roma
country: Italy
facility: Ospedale S Giovanni Calibita Fatebenefratelli
state: Lazio
city: Brescia
country: Italy
facility: IRCCS - Centro S. Giovanni di Dio Fatebenefratelli
state: Lombardia
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta
city: Modena
country: Italy
facility: Ospedale Civile di Baggiovara
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Ponderano
country: Italy
facility: Ospedale degli Infermi
city: 's-Hertogenbosch
country: Netherlands
facility: Brain Research Center Den Bosch
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: Brain Research Center Amsterdam
city: Christchurch
country: New Zealand
facility: CGM Research Trust
city: Wrocław
country: Poland
facility: NZOZ Wroclawskie Centrum Alzheimerowskie
state: Dolnoslaskie
city: Warszawa
country: Poland
facility: Centrum Medyczne NeuroProtect
state: Mazowieckie
city: Szczecin
country: Poland
facility: EUROMEDIS Sp. z o.o.
state: Zachodniopomorskie
city: Warsaw
country: Poland
facility: SOMED CR
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu i Sant Pau
state: Cataluña
city: Donostia
country: Spain
facility: Fundacion CITA Alzheimer Fundazioa
state: Guipuzcoa
city: Getxo
country: Spain
facility: Centro de Atencion Especializada Oroitu
state: Pais Vasco
city: Barcelona
country: Spain
facility: Fundacion ACE Instituto Catalan de Neurociencias
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
city: Zaragoza
country: Spain
facility: Hospital Viamed Montecanal
city: Guildford
country: United Kingdom
facility: Re: Cognition Health - Guildford
state: Surrey
city: Bristol
country: United Kingdom
facility: Re:Cognition Health Bristol
city: London
country: United Kingdom
facility: Re:Cognition Health London
city: London
country: United Kingdom
facility: The National Hospital for Neurology and Neurosurgery
city: Manchester
country: United Kingdom
facility: Greater Manchester Mental Health NHS Foundation Trust
city: Motherwell
country: United Kingdom
facility: Glasgow Memory Clinic
city: Plymouth
country: United Kingdom
facility: Re:Cognition Health Plymouth
Study officials:
name: TBD TBD
role: PRINCIPAL_INVESTIGATOR
References: