A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease (INVOKE-2)

October 15, 2025 updated by: Alector Inc.

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

A phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 in participants with Early Alzheimer's Disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

356

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Córdoba, Argentina, X5004AOA
        • Instituto Kremer
      • Mendoza, Argentina, 5500
        • Centro de Psiquiatría Biológica Instituto Senecta
  • Australia
    • New South Wales
      • Macquarie Park, New South Wales, Australia, 2113
        • KaRa Institute of Neurological Disease
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Parkville, Victoria, Australia, 3050
        • The Alfred Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • SMarT Minds WA
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1Z9
        • Okanagan Clinical Trials
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3S 1N2
        • True North Clinical Research - Halifax
      • New Minas, Nova Scotia, Canada, B4N 3R7
        • True North Clinical Research - New Minas
    • Ontario
      • London, Ontario, Canada, N6C 0A7
        • Parkwood Institute
      • Ottawa, Ontario, Canada, K1N 5C8
        • Bruyere Research Institute
      • Peterborough, Ontario, Canada, K9H 2P4
        • Kawartha Regional Memory Clinic
      • Toronto, Ontario, Canada, M3B 2S7
        • Toronto Memory Clinic
      • Toronto, Ontario, Canada, Ontario
        • Baycrest Health Sciences
  • France
      • Paris, France, 75010
        • Hôpital Lariboisière
      • Paris, France, 75013
        • Hopital de la Pitie Salpetriere
      • Toulouse, France, 31059
        • Centre Hospitalier Universitaire de Toulouse
      • Toulouse, France, 31059
        • Gerontopole
    • Nord
      • Lille, Nord, France, 59037
        • Hôpital Roger Salengro
  • Germany
      • Berlin, Germany, 13125
        • Charite Campus Buch
      • Berlin, Germany, 12203
        • Charité - Universitätsmedizin Berlin (CBF)
      • Mannheim, Germany, 68159
        • University Clinic Heidelberg
      • München, Germany, 81377
        • LMU Klinikum der Universität München
      • München, Germany, 81675
        • Klinikum rechts der Isa der Technischen Universitaet Muenchen
      • Ulm, Germany, 89081
        • Universitatsklinikum Ulm
  • Italy
      • Brescia, Italy, 25123
        • ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
      • Milan, Italy, 20133
        • Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta
      • Modena, Italy, 41126
        • Ospedale Civile di Baggiovara
      • Pisa, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana
      • Ponderano, Italy, 13875
        • Ospedale degli Infermi
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Fondazione Policlinico Universitario A Gemelli
      • Rome, Lazio, Italy, 00185
        • Azienda Policlinico Umberto I
      • Rome, Lazio, Italy, 00186
        • Ospedale S Giovanni Calibita Fatebenefratelli
    • Lombardy
      • Brescia, Lombardy, Italy, 25125
        • IRCCS - Centro S. Giovanni di Dio Fatebenefratelli
  • Netherlands
      • Amsterdam, Netherlands, 1081 GN
        • Brain Research Center Amsterdam
    • North Brabant
      • 's-Hertogenbosch, North Brabant, Netherlands, 5223 GV
        • Brain Research Center Den Bosch
  • New Zealand
      • Christchurch, New Zealand, 8083
        • CGM Research Trust
  • Poland
      • Warsaw, Poland, 01-737
        • SOMED CR
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 53-110
        • NZOZ Wroclawskie Centrum Alzheimerowskie
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 01-684
        • Centrum Medyczne NeuroProtect
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Poland, 70-111
        • Euromedis Sp. z o.o.
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08028
        • Fundacion ACE Instituto Catalan de Neurociencias
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe de Valencia
      • Valencia, Spain, 46017
        • Hospital Universitario Doctor Peset
      • Zaragoza, Spain, 50012
        • Hospital Viamed Montecanal
    • Basque Country
      • Getxo, Basque Country, Spain, 48993
        • Centro De Atencion Especializada Oroitu
    • Catalonia
      • Barcelona, Catalonia, Spain, 08041
        • Hospital de la Santa Creu i Sant Pau
    • Guipuzcoa
      • Donostia / San Sebastian, Guipuzcoa, Spain, 20009
        • Fundacion CITA Alzheimer Fundazioa
  • United Kingdom
      • Bristol, United Kingdom, BS32 4SY
        • Re:Cognition Health Bristol
      • London, United Kingdom, WC1N 3BG
        • The National Hospital for Neurology and Neurosurgery
      • London, United Kingdom, W1G 9JF
        • Re:Cognition Health London
      • Manchester, United Kingdom, M8 5RB
        • Greater Manchester Mental Health NHS Foundation Trust
      • Motherwell, United Kingdom, ML1 4UF
        • Glasgow Memory Clinic
      • Plymouth, United Kingdom, Pl6 8BT
        • Re:Cognition Health Plymouth
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7YD
        • Re: Cognition Health - Guildford
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner Alzheimer's Institute
    • Arkansas
      • Rogers, Arkansas, United States, 72758
        • Woodlands Research Network, LLC - ERG
    • California
      • Costa Mesa, California, United States, 92626
        • ATP Clinical Research
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Georgetown University Medical Center
    • Florida
      • Boca Raton, Florida, United States, 33487
        • South Florida Neurology Associates
      • Delray Beach, Florida, United States, 33445
        • Brain Matters Research - ERG
      • Lady Lake, Florida, United States, 32159
        • Charter Research
      • Maitland, Florida, United States, 32751
        • K2 Medical Research
      • Maitland, Florida, United States, 32751
        • ClinCloud, LLC
      • Ocoee, Florida, United States, 34761
        • K2 Winter Garden Ocoee
      • Port Orange, Florida, United States, 32127-5170
        • Progressive Medical Research
      • Tampa, Florida, United States, 33609
        • Axiom Clinical Research FL
      • The Villages, Florida, United States, 32159
        • K2 The Villages
      • Wellington, Florida, United States, 33449
        • Alzheimers Research and Treatment Center
      • Winter Park, Florida, United States, 32789
        • Conquest Clinical Research (Winter Park)
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • AMITA Health Clinical Research Institute
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University Of Kentucky
    • Massachusetts
      • Newton, Massachusetts, United States, 02459
        • Boston Center for Memory
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Hattiesburg Clinic
    • New Jersey
      • Neptune City, New Jersey, United States, 07753
        • Advanced Clinical Institute
    • New York
      • Manhasset, New York, United States, 11030
        • Feinstein Institute For MR
      • New York, New York, United States, 10032-3725
        • Columbia University College of Physicians and Surgeons
      • Rochester, New York, United States, 14620
        • University of Rochester Medical Center
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati MC
    • Oregon
      • Portland, Oregon, United States, 97210
        • Summit Research Network
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19090
        • Abington Neurologic Associates
    • Texas
      • Houston, Texas, United States, 77074-2085
        • Clinical Trial Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo every 4 weeks
Drug: Placebo
Administered via intravenous (IV) infusion
Experimental: AL002 Dose 1
AL002 every 4 weeks
Drug: AL002
Administered via intravenous (IV) infusion
Experimental: AL002 Dose 2
AL002 every 4 weeks
Drug: AL002
Administered via intravenous (IV) infusion
Experimental: AL002 Dose 3
AL002 every 4 weeks
Drug: AL002
Administered via intravenous (IV) infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
Time Frame: 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.
Study completion up to 96 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mini-Mental Status Examination (MMSE) Score
Time Frame: Study completion up to 96 weeks

Change from baseline in Mini-Mental Status Examination (MMSE) score at Weeks 24, 48, 72, and 96

The MMSE is a test that assesses orientation, registration, attention and calculation, recent memory, language and constructional praxis. There is a total possible score of 30 with a lower score correlating to a higher cognitive impairment. A score of 24 to 30 is considered normal or no cognitive impairment. A score of 18 to 24 indicates mild impairment. A score of 0 to 17 indicates a severe impairment.
Study completion up to 96 weeks
Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score
Time Frame: Study completion up to 96 weeks

Change from baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score at Weeks 24, 48, 72 and 96

The RBANS test is a collection of 12 subsets representing 5 neurological domains: immediate memory, visuospatial/constructional, language, attention, and delayed memory. The scores are converted to a scale that can range from 40 to 160. The lower the score the greater the cognitive impairment.
Study completion up to 96 weeks
Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score
Time Frame: Study completion up to 96 weeks

Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) score at Weeks 24, 48, 72, and 96

The ADAS-Cog13 is a scale that includes 13 items to assess cognitive function. These domains include memory, language, praxis, and orientation, as well as a number cancellation task and a delayed free recall task. There is a total score range of 0 to 85. A higher score on this scale indicates greater cognitive impairment. There are currently no universally accepted severity bands for ADAS-Cog13 as it is used to track changes in disease and not for severity.
Study completion up to 96 weeks
Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL-MCI) Score
Time Frame: Study completion up to 96 weeks

Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL-MCI) score at Weeks 24, 48, 72, and 96

The ADCS-ADL-MCI is a scale for participants with mild cognitive impairment that observes their performance in completing activities associated with daily living. This scale is a multiple choice questionnaire and has a range of 0 to 53. A lower score on this scale indicates greater cognitive impairment.
Study completion up to 96 weeks
Change in Alzheimer's Disease Composite Score (ADCOMS) Score
Time Frame: Study completion up to 96 weeks

Change from baseline in Alzheimer's Disease Composite Score (ADCOMS) score at Weeks 24, 48, 72, and 96

The ADCOMS scale is a composite score of 12 components that include 4 items from the ADAS-Cog13, 2 items from the MMSE, and all 6 items from the CDR-SB scales. The range of the ADCOMS is between 0 and 1.97. The higher the score the greater the cognitive impairment.
Study completion up to 96 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Change in brain volume as assessed by magnetic resonance imaging
Time Frame: Through study completion, up to 48 through 96 weeks
Through study completion, up to 48 through 96 weeks
Change in blood based biomarkers
Time Frame: Through study completion, up to 48 through 96 weeks
Through study completion, up to 48 through 96 weeks
Change in CSF biomarkers (optional)
Time Frame: Through study completion, up to 48 through 96 weeks
Through study completion, up to 48 through 96 weeks
Change in amyloid burden as assessed by positron emission tomography imaging (optional)
Time Frame: Through study completion, up to 48 through 96 weeks
Through study completion, up to 48 through 96 weeks
Change in tau tangles as assessed by positron emission tomography imaging (optional)
Time Frame: Through study completion, up to 48 through 96 weeks
Through study completion, up to 48 through 96 weeks
Change in Winterlight Language Speech Assessment score (optional)
Time Frame: Through study completion, up to 48 through 96 weeks
Through study completion, up to 48 through 96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alector Inc.

Collaborators

AbbVie

Investigators

  • Principal Investigator: Catherine Mummery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2021

Primary Completion (Actual)

August 19, 2024

Study Completion (Actual)

September 12, 2024

Study Registration Dates

First Submitted

September 17, 2020

First Submitted That Met QC Criteria

October 13, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Estimated)

October 29, 2025

Last Update Submitted That Met QC Criteria

October 15, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AL002-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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