A Long-term Extension Study to Evaluate Safety, Tolerability, and Efficacy of AL002 in Alzheimer's Disease

A Multicenter, Long-term Extension Study to Evaluate the Safety, Tolerability, and Efficacy of AL002 in Participants With Alzheimer's Disease

A long-term extension study to evaluate the safety, tolerability, and efficacy of AL002 in participants with Early Alzheimer's Disease.

Study Overview

• Status: Terminated
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: AL002

Detailed Description

This is a Phase 2, parallel-group, long-term extension (LTE), dose-blind study to evaluate the long-term safety and efficacy of AL002 in participants with Early Alzheimer's Disease. The study is a multicenter, global trial that will enroll participants who completed the planned treatment period in AL002-2 (parent study).

• Study Type: Interventional
• Enrollment (Actual): 197
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Córdoba Province
    • Córdoba, Córdoba Province, Argentina, X5004AOA
      • Instituto Privado Kremer
  • Mendoza Province
    • Mendoza, Mendoza Province, Argentina, 05500
      • Centro de Psiquiatria Biologica
• 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
    • Melbourne, Victoria, Australia, 3004
      • Alfred Health
• Canada
  • Ontario
    • Peterborough, Ontario, Canada, K9H 2P4
      • Kawartha Regional Memory Clinic
    • Toronto, Ontario, Canada, M6A 2X8
      • Baycrest Health Sciences
• Germany
  • Baden-Wurttemberg
    • Ulm, Baden-Wurttemberg, Germany, 89081
      • Universitätsklinikum Ulm-Oberer Eselsberg 45
  • Bavaria
    • Munich, Bavaria, Germany, 81675
      • Klinikum Rechts der Isar der Technischen Universitaet Muenchen
  • State of Berlin
    • Berlin, State of Berlin, Germany, 12200
      • Ambulantes Gesundheitszebtrum der Charite GmbH
    • Berlin, State of Berlin, Germany, 13125
      • Charité - Universitätsmedizin Berlin
• Italy
  • Pisa, Italy
    • Azienda Ospedaliero Universitaria Pisana
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Fondazione Policlinico Universitario A Gemelli-Rome
    • Rome, Lazio, Italy, 00186
      • Ospedale Isola Tiberina - Gemelli Isola
    • Rome, Lazio, Italy, 00185
      • Azienda Policlinico Umberto
  • Lombardy
    • Brescia, Lombardy, Italy, 25123
      • ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN
    • Brescia, Lombardy, Italy, 25125
      • IRCCS - Centro S. Giovanni di Dio Fatebene fratelli
    • Milan, Lombardy, Italy, 20122
      • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
    • Milan, Lombardy, Italy, 20133
      • Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-VIA MANGIAGALLI 3
  • Modena
    • Modena, Modena, Italy, 41126
      • Azienda Ospedaliero-Universitaria di Modena - Policlinico di Modena
  • Piedmont
    • Ponderano, Piedmont, Italy, 13875
      • ASL Biella - Ospedale degli Infermi
• Netherlands
  • North Brabant
    • 's-Hertogenbosch, North Brabant, Netherlands, 5223 LA
      • Brain Research Center Den Bosch - PPDS
• Poland
  • 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
    • Barcelona, Barcelona, Spain, 08025
      • Hospital de la Santa Creu i Sant Pau
    • Barcelona, Barcelona, Spain, 8028
      • Fundacion ACE Instituto Catalan de Neurociencias-Gran via de Carles III, 85 bis
  • Guipúzcoa
    • San Sebastián, Guipúzcoa, Spain, 20009
      • Fundacion CITA Alzheimer Fundazioa
  • Madrid
    • Madrid, Madrid, Spain, 28034
      • Hospital Universitario Ramón y Cajal
  • Valencia
    • Valencia, Valencia, Spain, 46017
      • Hospital Universitario Doctor Peset
    • Valencia, Valencia, Spain, 46026
      • Hospital Universitari i Politecnic La Fe de Valencia
  • Vizcaya
    • Getxo, Vizcaya, Spain, 48993
      • Centro De Atencion Especializada Oroitu
  • Zaragoza
    • Zaragoza, Zaragoza, Spain, 50012
      • Hospital Viamed Montecanal
• United Kingdom
  • London, United Kingdom, WC1N 3BG
    • The National Hospital for Neurology and Neurosurgery
  • London, United Kingdom, W1G 9RU
    • Re:Cognition Health
  • Motherwell, United Kingdom, ML1 4UF
    • NeuroClin Glasgow
  • Bristol
    • Bristol, Bristol, United Kingdom, BS32 4SY
      • Re-Cognition Health - Bristol
  • Devon
    • Plymouth, Devon, United Kingdom, PL6 8BT
      • RE: Cognition Health - Plymouth
  • Surrey
    • Guildford, Surrey, United Kingdom, GU2 7YD
      • Re:Cognition Health - Guildford - PPDS
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner Alzheimer's Institute
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Georgetown University Medical Center
  • Florida
    • Boca Raton, Florida, United States, 33487
      • SFM Clinical Research, LLC
    • Lady Lake, Florida, United States, 32159
      • Charter Research
    • Maitland, Florida, United States, 32751
      • K2 Medical Research - Maitland
    • Port Orange, Florida, United States, 32127
      • Progressive Medical Research - ClinEdge - PPDS
    • Tampa, Florida, United States, 33609
      • Axiom Brain Health LLC
    • Wellington, Florida, United States, 33449
      • "Alzheimers Research and Treatment Center-Wellington "
    • Winter Park, Florida, United States, 32819
      • Conquest Research LLC - Winter Park - ClinEdge - PPDS
  • 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 Medical Research
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Medical Center
  • Oregon
    • Portland, Oregon, United States, 97210
      • Summit Research Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Completion of the Planned Treatment Period in the AL002-2 study.
• The participant is willing and able to give informed consent.
• Study partner who consents to study participation and who cares for/visits the participant at least 10 hours a week

Exclusion Criteria:

• Participants deemed not able to provide consent or assent by the Investigator or by local regulations.
• Participants who were prematurely and permanently discontinued from treatment in the parent study for safety reasons.
• Participation deemed inappropriate per Investigator discretion.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
Safety and Tolerability as Measured by Number of Treatment-expected Adverse Events (TEAE) and Treatment-related Adverse Events (AEs).	Adverse Events are any untoward medical occurrence in a participant enrolled in this study, including side effects, injury, toxicity, sensitivity reaction, intercurrent illnesses, clinically significant physical exam signs, or sudden death, whether or not it is considered related to the study drug.	From the Screening period and throughout the treatment period until the end of study participation, up to 49 weeks.
Safety and Tolerability as Measured by Number of Adverse Events of Special Interest and Serious Adverse Events	Adverse Events are any untoward medical occurrence in a participant enrolled in this study, including side effects, injury, toxicity, sensitivity reaction, intercurrent illnesses, clinically significant physical exam signs, or sudden death, whether or not it is considered related to the study drug.	From the Screening period and throughout the treatment period until the end of study participation, up to 49 weeks.
Safety and Tolerability as Measured by the Number of Cases of Abnormal Vital Signs, Clinical Laboratory Results and Findings From Physical, Neurological, Ophthalmological Examinations and Electrocardiograms.	Evaluation of vital signs (blood pressure, pulse, temperature), clinical laboratory results (hematology, biochemistry, urinalysis), and findings from physical, neurological, ophthalmological examinations, and electrocardiograms.	From the Screening period and throughout the treatment period until the end of study completion, up to 49 weeks
To Evaluate the Long-term Safety and Tolerability of AL002, by Assessing the Number of Suicidal Risk Events Using the Columbia-Suicide Severity Rating Scale (C-SSRS)	Two versions of the C-SSRS were used in the parent study: a Screening/Baseline version and a Since Last Visit version. The Screening/Baseline version of the C-SSRS assesses the lifetime suicidal ideation and behavior and non-suicidal self-injurious behavior, the suicidal ideation in the past 6 months, and suicidal behavior and non-suicidal self-injurious behavior in the past two years. The C-SSRS uses a point scale where a higher score indicates a greater risk of suicidality.	From the Screening period and throughout the treatment period until the end of the study participation up to 49 weeks.
To Evaluate the Effect of Dose Titration on the Occurrence of ARIA-E by Assessing the Number of Participants With ARIA-E Events	Among the brain abnormalities detected on MRI are ARIA, which are believed to reflect leakage of proteinaceous fluid or other blood products in the leptomeninges or brain parenchyma. The term ARIA was originally coined to describe specific brain abnormalities seen on MRI in anti-amyloid clinical trials. Specifically, according to the convention developed to describe ARIA occurring in clinical trials of anti-amyloid immunotherapies, ARIA-E refers to MRI findings of vasogenic edema and leptomeningeal/sulcal effusion.	Screening, Week 9, Week 17, Week 25, Week 33, Week 41, End of Study visit, and Early Termination visit, if applicable up to 49 weeks
To Evaluate the Effect of Dose Titration on the Occurrence of ARIA-H by Assessing the Number of Participants With ARIA-H Events	Among the brain abnormalities detected on MRI are ARIA, which are believed to reflect leakage of proteinaceous fluid or other blood products int the leptomeninges or brain parenchyma. The term ARIA was originally coined to describe specific brain abnormalities seen on MRI in anti-amyloid clinical trials. Specifically, according to the convention developed to describe ARIA occurring in clinical trials of anti-amyloid immunotherapies, ARIA-H refers to MRI findings of cerebral microhemorrhages, leptomeningeal hemosiderosis, and cerebral macrohemorrhages.	Screening, Week 9, Week 17, Week 25, Week 33, Week 41, End of Study visit, and Early Termination visit, if applicable up to 49 weeks

Collaborators and Investigators

• Sponsor: Alector Inc.
• Collaborators: AbbVie
• Investigators: Principal Investigator: TBD TBD

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2023
• Primary Completion (Actual): January 31, 2025
• Study Completion (Actual): February 5, 2025

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease
• Other Study ID Numbers: AL002-LTE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No