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

NCT ID: NCT05744401

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-04

Study Completion Date

2025-01-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AL002 Dose 1

AL002 every 4 weeks

Group Type EXPERIMENTAL

AL002

Intervention Type DRUG

Administered via intravenous (IV) infusion

AL002 Dose 2

AL002 every 4 weeks

Group Type EXPERIMENTAL

AL002

Intervention Type DRUG

Administered via intravenous (IV) infusion

AL002 Dose 3

AL002 every 4 weeks

Group Type EXPERIMENTAL

AL002

Intervention Type DRUG

Administered via intravenous (IV) infusion

Interventions

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AL002

Administered via intravenous (IV) infusion

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role collaborator

Alector Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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TBD TBD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Banner Alzheimer's Institute

Phoenix, Arizona, United States

Site Status

Georgetown University Medical Center

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

Site Status

SFM Clinical Research, LLC

Boca Raton, Florida, United States

Site Status

Charter Research

Lady Lake, Florida, United States

Site Status

K2 Medical Research - Maitland

Maitland, Florida, United States

Site Status

Progressive Medical Research - ClinEdge - PPDS

Port Orange, Florida, United States

Site Status

Axiom Brain Health LLC

Tampa, Florida, United States

Site Status

"Alzheimers Research and Treatment Center-Wellington "

Wellington, Florida, United States

Site Status

Conquest Research LLC - Winter Park - ClinEdge - PPDS

Winter Park, Florida, United States

Site Status

Hattiesburg Clinic

Hattiesburg, Mississippi, United States

Site Status

Advanced Clinical Institute

Neptune City, New Jersey, United States

Site Status

Feinstein Institute For Medical Research

Manhasset, New York, United States

Site Status

SUNY Upstate Medical Center

Syracuse, New York, United States

Site Status

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Site Status

Summit Research Network

Portland, Oregon, United States

Site Status

Instituto Privado Kremer

Córdoba, Córdoba Province, Argentina

Site Status

Centro de Psiquiatria Biologica

Mendoza, , Argentina

Site Status

KaRa Institute of Neurological Disease

Macquarie Park, New South Wales, Australia

Site Status

Box Hill Hospital

Box Hill, Victoria, Australia

Site Status

Alfred Health

Melbourne, Victoria, Australia

Site Status

Kawartha Regional Memory Clinic

Peterborough, Ontario, Canada

Site Status

Baycrest Health Sciences

Toronto, Ontario, Canada

Site Status

Universitätsklinikum Ulm-Oberer Eselsberg 45

Ulm, Baden-Wurttemberg, Germany

Site Status

Klinikum rechts der Isar der Technischen Universitaet Muenchen

Munich, Bavaria, Germany

Site Status

Ambulantes Gesundheitszebtrum der Charite GmbH

Berlin, , Germany

Site Status

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Fondazione Policlinico Universitario A Gemelli-Rome

Rome, Lazio, Italy

Site Status

Azienda Policlinico Umberto

Rome, Lazio, Italy

Site Status

Ospedale Isola Tiberina - Gemelli Isola

Rome, Lazio, Italy

Site Status

ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN

Brescia, Lombardy, Italy

Site Status

IRCCS - Centro S. Giovanni di Dio Fatebene fratelli

Brescia, Lombardy, Italy

Site Status

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Lombardy, Italy

Site Status

Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-VIA MANGIAGALLI 3

Milan, Lombardy, Italy

Site Status

ASL Biella - Ospedale degli Infermi

Ponderano, Piedmont, Italy

Site Status

Azienda Ospedaliero-Universitaria di Modena - Policlinico di Modena

Modena, , Italy

Site Status

Azienda Ospedaliero Universitaria Pisana

Pisa, , Italy

Site Status

Brain Research Center Den Bosch - PPDS

's-Hertogenbosch, North Brabant, Netherlands

Site Status

NZOZ Wroclawskie Centrum Alzheimerowskie

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status

Centrum Medyczne NeuroProtect

Warsaw, Masovian Voivodeship, Poland

Site Status

EUROMEDIS Sp. z o.o.

Szczecin, West Pomeranian Voivodeship, Poland

Site Status

Fundacion CITA Alzheimer Fundazioa

San Sebastián, Guipúzcoa, Spain

Site Status

Centro De Atencion Especializada Oroitu

Getxo, Vizcaya, Spain

Site Status

Hospital de La Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Fundacion ACE Instituto Catalan de Neurociencias-Gran via de Carles III, 85 bis

Barcelona, , Spain

Site Status

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Site Status

Hospital Universitario Doctor Peset

Valencia, , Spain

Site Status

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, , Spain

Site Status

Hospital Viamed Montecanal

Zaragoza, , Spain

Site Status

RE: Cognition Health - Plymouth

Plymouth, Devon, United Kingdom

Site Status

Re:Cognition Health - Guildford - PPDS

Guildford, Surrey, United Kingdom

Site Status

Re-Cognition Health - Bristol

Bristol, , United Kingdom

Site Status

Re:Cognition Health

London, , United Kingdom

Site Status

The National Hospital for Neurology and Neurosurgery

London, , United Kingdom

Site Status

NeuroClin Glasgow

Motherwell, , United Kingdom

Site Status

Countries

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United States Argentina Australia Canada Germany Italy Netherlands Poland Spain United Kingdom

Other Identifiers

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AL002-LTE

Identifier Type: -

Identifier Source: org_study_id

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