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

February 6, 2026 updated by: Alector Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
197

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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 Cà 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 Ramon 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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).
Time Frame: From the Screening period and throughout the treatment period until the end of study participation, up to 49 weeks.
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
Time Frame: From the Screening period and throughout the treatment period until the end of study participation, up to 49 weeks.
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.
Time Frame: From the Screening period and throughout the treatment period until the end of study completion, up to 49 weeks
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)
Time Frame: From the Screening period and throughout the treatment period until the end of the study participation up to 49 weeks.
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
Time Frame: 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
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
Time Frame: 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
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

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alector Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AbbVie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: TBD TBD

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 4, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 5, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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