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

NCT04592874 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: AL002-2
• Study Type: interventional
• Target: 356
• Locations: 12 countries
• Sites: 87

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score

  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 Outcomes (5)

• Change in Mini-Mental Status Examination (MMSE) Score

  Study completion up to 96 weeks

• Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score

  Study completion up to 96 weeks

• Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score

  Study completion up to 96 weeks

• Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL-MCI) Score

  Study completion up to 96 weeks

• Change in Alzheimer's Disease Composite Score (ADCOMS) Score

  Study completion up to 96 weeks

Study Arms (4)

AL002 Dose 1

EXPERIMENTAL

AL002 every 4 weeks

Drug: AL002

AL002 Dose 2

EXPERIMENTAL

AL002 every 4 weeks

Drug: AL002

AL002 Dose 3

EXPERIMENTAL

AL002 every 4 weeks

Drug: AL002

Placebo

PLACEBO COMPARATOR

Placebo every 4 weeks

Drug: Placebo

Interventions

AL002 DRUG

Administered via intravenous (IV) infusion

AL002 Dose 1; AL002 Dose 2; AL002 Dose 3

Placebo DRUG

Administered via intravenous (IV) infusion

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alector Inc.: lead

Study Sites (87)

Banner Alzheimer's Institute

Phoenix, Arizona, 85006, United States

Location

Woodlands Research Network, LLC - ERG

Rogers, Arkansas, 72758, United States

Location

ATP Clinical Research

Costa Mesa, California, 92626, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

South Florida Neurology Associates

Boca Raton, Florida, 33487, United States

Location

Brain Matters Research - ERG

Delray Beach, Florida, 33445, United States

Location

Charter Research

Lady Lake, Florida, 32159, United States

Location

ClinCloud, LLC

Maitland, Florida, 32751, United States

Location

K2 Medical Research

Maitland, Florida, 32751, United States

Location

K2 Winter Garden Ocoee

Ocoee, Florida, 34761, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127-5170, United States

Location

Axiom Clinical Research FL

Tampa, Florida, 33609, United States

Location

K2 The Villages

The Villages, Florida, 32159, United States

Location

Alzheimers Research and Treatment Center

Wellington, Florida, 33449, United States

Location

Conquest Clinical Research (Winter Park)

Winter Park, Florida, 32789, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

AMITA Health Clinical Research Institute

Elk Grove Village, Illinois, 60007, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Boston Center for Memory

Newton, Massachusetts, 02459, United States

Location

Hattiesburg Clinic

Hattiesburg, Mississippi, 39401, United States

Location

Advanced Clinical Institute

Neptune City, New Jersey, 07753, United States

Location

Feinstein Institute For MR

Manhasset, New York, 11030, United States

Location

Columbia University College of Physicians and Surgeons

New York, New York, 10032-3725, United States

Location

University of Rochester Medical Center

Rochester, New York, 14620, United States

Location

SUNY Upstate Medical Center

Syracuse, New York, 13210, United States

Location

University of Cincinnati MC

Cincinnati, Ohio, 45219, United States

Location

Summit Research Network

Portland, Oregon, 97210, United States

Location

Abington Neurologic Associates

Abington, Pennsylvania, 19090, United States

Location

Clinical Trial Network

Houston, Texas, 77074-2085, United States

Location

Instituto Kremer

Córdoba, X5004AOA, Argentina

Location

Centro de Psiquiatría Biológica Instituto Senecta

Mendoza, 5500, Argentina

Location

KaRa Institute of Neurological Disease

Macquarie Park, New South Wales, 2113, Australia

Location

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

The Alfred Hospital

Parkville, Victoria, 3050, Australia

Location

SMarT Minds WA

Nedlands, Western Australia, 6009, Australia

Location

Okanagan Clinical Trials

Kelowna, British Columbia, V1Y 1Z9, Canada

Location

True North Clinical Research - Halifax

Halifax, Nova Scotia, B3S 1N2, Canada

Location

True North Clinical Research - New Minas

New Minas, Nova Scotia, B4N 3R7, Canada

Location

Parkwood Institute

London, Ontario, N6C 0A7, Canada

Location

Bruyère Research Institute

Ottawa, Ontario, K1N 5C8, Canada

Location

Kawartha Regional Memory Clinic

Peterborough, Ontario, K9H 2P4, Canada

Location

Toronto Memory Clinic

Toronto, Ontario, M3B 2S7, Canada

Location

Baycrest Health Sciences

Toronto, Ontario, Ontario, Canada

Location

Hôpital Roger Salengro

Lille, Nord, 59037, France

Location

Hopital Lariboisiere

Paris, 75010, France

Location

Hôpital de la Pitié Salpétrière

Paris, 75013, France

Location

Centre Hospitalier Universitaire de Toulouse

Toulouse, 31059, France

Location

Gerontopole

Toulouse, 31059, France

Location

Charité - Universitätsmedizin Berlin (CBF)

Berlin, 12203, Germany

Location

Charite Campus Buch

Berlin, 13125, Germany

Location

University Clinic Heidelberg

Mannheim, 68159, Germany

Location

LMU Klinikum der Universität München

München, 81377, Germany

Location

Klinikum rechts der Isa der Technischen Universitaet Muenchen

München, 81675, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

Fondazione Policlinico Universitario A Gemelli

Rome, Lazio, 00168, Italy

Location

Azienda Policlinico Umberto I

Rome, Lazio, 00185, Italy

Location

Ospedale S Giovanni Calibita Fatebenefratelli

Rome, Lazio, 00186, Italy

Location

IRCCS - Centro S. Giovanni di Dio Fatebenefratelli

Brescia, Lombardy, 25125, Italy

Location

ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia

Brescia, 25123, Italy

Location

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta

Milan, 20133, Italy

Location

Ospedale Civile di Baggiovara

Modena, 41126, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126, Italy

Location

Ospedale degli Infermi

Ponderano, 13875, Italy

Location

Brain Research Center Den Bosch

's-Hertogenbosch, North Brabant, 5223 GV, Netherlands

Location

Brain Research Center Amsterdam

Amsterdam, 1081 GN, Netherlands

Location

CGM Research Trust

Christchurch, 8083, New Zealand

Location

NZOZ Wroclawskie Centrum Alzheimerowskie

Wroclaw, Lower Silesian Voivodeship, 53-110, Poland

Location

Centrum Medyczne NeuroProtect

Warsaw, Masovian Voivodeship, 01-684, Poland

Location

EUROMEDIS Sp. z o.o.

Szczecin, West Pomeranian Voivodeship, 70-111, Poland

Location

SOMED CR

Warsaw, 01-737, Poland

Location

Centro de Atencion Especializada Oroitu

Getxo, Basque Country, 48993, Spain

Location

Hospital de La Santa Creu i Sant Pau

Barcelona, Catalonia, 08041, Spain

Location

Fundacion CITA Alzheimer Fundazioa

Donostia / San Sebastian, Guipuzcoa, 20009, Spain

Location

Fundacion ACE Instituto Catalan de Neurociencias

Barcelona, 08028, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Doctor Peset

Valencia, 46017, Spain

Location

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, 46026, Spain

Location

Hospital Viamed Montecanal

Zaragoza, 50012, Spain

Location

Re: Cognition Health - Guildford

Guildford, Surrey, GU2 7YD, United Kingdom

Location

Re:Cognition Health Bristol

Bristol, BS32 4SY, United Kingdom

Location

Re:Cognition Health London

London, W1G 9JF, United Kingdom

Location

The National Hospital for Neurology and Neurosurgery

London, WC1N 3BG, United Kingdom

Location

Greater Manchester Mental Health NHS Foundation Trust

Manchester, M8 5RB, United Kingdom

Location

Glasgow Memory Clinic

Motherwell, ML1 4UF, United Kingdom

Location

Re:Cognition Health Plymouth

Plymouth, Pl6 8BT, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 40145953 DERIVED

• 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.

  PMID: 36934371 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Alector Medical Information
• Organization: Alector

medinfo@alector.com

650-826-2454

Study Officials

• Catherine Mummery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: October 19, 2020
• Study Start: January 22, 2021
• Primary Completion: August 19, 2024
• Study Completion: September 12, 2024
• Last Updated: October 29, 2025
• Results First Posted: October 29, 2025

Record last verified: 2025-08

Locations

GB (7); NL (2); NZ (1); US (29); CA (8); PL (4); AU (4); DE (6); FR (5); IT (10); AR (2); ES (9)