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

Phase 2

Recruiting

• Conditions: Alzheimer's Disease
• Interventions: Drug: AL002

• Registration Number: NCT05744401
• Lead Sponsor: Alector Inc.

Brief Summary

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

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 Timeline

• Study Start: 2023-01-04
• Study First Submitted: 2023-01-19
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-10
• Primary Completion: 2025-09
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AL002 Dose 1	AL002	AL002 every 4 weeks
AL002 Dose 2	AL002	AL002 every 4 weeks
AL002 Dose 3	AL002	AL002 every 4 weeks

Primary Outcome Measures

Name	Time	Method
Safety and tolerability as measured by the number of incidence/MRI abnormalities.	Through study completion, up to 49 weeks
Safety and tolerability as measured by number of/incidence of Adverse Events (AEs), including AESI and SAEs.	Through study completion, up to 49 weeks

Trial Locations

Locations (54)

SFM Clinical Research, LLC; 🇺🇸 Boca Raton, Florida, United States

Banner Alzheimer's Institute; 🇺🇸 Phoenix, Arizona, United States

Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States

Charter Research; 🇺🇸 Lady Lake, Florida, United States

K2 Medical Research - Maitland; 🇺🇸 Maitland, Florida, United States

Progressive Medical Research - ClinEdge - PPDS; 🇺🇸 Port Orange, Florida, United States

Axiom Brain Health LLC; 🇺🇸 Tampa, Florida, United States

"Alzheimers Research and Treatment Center-Wellington "; 🇺🇸 Wellington, Florida, United States

Conquest Research LLC - Winter Park - ClinEdge - PPDS; 🇺🇸 Winter Park, Florida, United States

Hattiesburg Clinic; 🇺🇸 Hattiesburg, Mississippi, United States

Advanced Clinical Institute; 🇺🇸 Neptune, New Jersey, United States

Feinstein Institute For Medical Research; 🇺🇸 Manhasset, New York, United States

SUNY Upstate Medical Center; 🇺🇸 Syracuse, New York, United States

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Summit Research Network; 🇺🇸 Portland, Oregon, United States

Instituto Privado Kremer; 🇦🇷 Córdoba, Cordoba, Argentina

Centro de Psiquiatria Biologica; 🇦🇷 Mendoza, Argentina

KaRa Institute of Neurological Disease; 🇦🇺 Macquarie Park, New South Wales, Australia

Box Hill Hospital; 🇦🇺 Box Hill, Victoria, Australia

Alfred Health; 🇦🇺 Melbourne, Victoria, Australia

Kawartha Regional Memory Clinic; 🇨🇦 Peterborough, Ontario, Canada

Baycrest Health Sciences; 🇨🇦 Toronto, Ontario, Canada

Universitätsklinikum Ulm-Oberer Eselsberg 45; 🇩🇪 Ulm, Baden-Württemberg, Germany

Klinikum rechts der Isar der Technischen Universitaet Muenchen; 🇩🇪 Muenchen, Bayern, Germany

Ambulantes Gesundheitszebtrum der Charite GmbH; 🇩🇪 Berlin, Germany

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Azienda Policlinico Umberto; 🇮🇹 Roma, Lazio, Italy

Fondazione Policlinico Universitario A Gemelli-Rome; 🇮🇹 Rome, Lazio, Italy

Ospedale Isola Tiberina - Gemelli Isola; 🇮🇹 Rome, Lazio, Italy

ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN; 🇮🇹 Brescia, Lombardia, Italy

IRCCS - Centro S. Giovanni di Dio Fatebene fratelli; 🇮🇹 Brescia, Lombardia, Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico; 🇮🇹 Milano, Lombardia, Italy

Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-VIA MANGIAGALLI 3; 🇮🇹 Milano, Lombardia, Italy

ASL Biella - Ospedale degli Infermi; 🇮🇹 Ponderano, Piemonte, Italy

Azienda Ospedaliero-Universitaria di Modena - Policlinico di Modena; 🇮🇹 Modena, Italy

Azienda Ospedaliero Universitaria Pisana; 🇮🇹 Pisa, Italy

Brain Research Center Den Bosch - PPDS; 🇳🇱 's-Hertogenbosch, Noord-Brabant, Netherlands

NZOZ Wroclawskie Centrum Alzheimerowskie; 🇵🇱 Wroclaw, Dolnoslaskie, Poland

Centrum Medyczne NeuroProtect; 🇵🇱 Warszawa, Mazowieckie, Poland

EUROMEDIS Sp. z o.o.; 🇵🇱 Szczecin, Zachodniopomorskie, Poland

Fundacion CITA Alzheimer Fundazioa; 🇪🇸 San Sebastián, Guipúzcoa, Spain

Centro De Atencion Especializada Oroitu; 🇪🇸 Getxo, Vizcaya, Spain

Hospital de La Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Fundacion ACE Instituto Catalan de Neurociencias-Gran via de Carles III, 85 bis; 🇪🇸 Barcelona, Spain

Hospital Universitario Ramon y Cajal; 🇪🇸 Madrid, Spain

Hospital Universitario Doctor Peset; 🇪🇸 Valencia, Spain

Hospital Universitari i Politecnic La Fe de Valencia; 🇪🇸 Valencia, Spain

Hospital Viamed Montecanal; 🇪🇸 Zaragoza, Spain

RE: Cognition Health - Plymouth; 🇬🇧 Plymouth, Devon, United Kingdom

Re:Cognition Health - Guildford - PPDS; 🇬🇧 Guildford, Surrey, United Kingdom

Re-Cognition Health - Bristol; 🇬🇧 Bristol, United Kingdom

Re:Cognition Health; 🇬🇧 London, United Kingdom

The National Hospital for Neurology and Neurosurgery; 🇬🇧 London, United Kingdom

NeuroClin Glasgow; 🇬🇧 Motherwell, United Kingdom