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

NCT05744401 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: AL002-LTE
• Study Type: interventional
• Target: 197
• Locations: 10 countries
• Sites: 54

Brief Summary

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

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (3)

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

Interventions

AL002 DRUG

Administered via intravenous (IV) infusion

AL002 Dose 1; AL002 Dose 2; AL002 Dose 3

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alector Inc.: lead
• AbbVie: collaborator

Study Sites (54)

Banner Alzheimer's Institute

Phoenix, Arizona, 85006, United States

Location

Georgetown University Medical Center

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

Location

SFM Clinical Research, LLC

Boca Raton, Florida, 33487, United States

Location

Charter Research

Lady Lake, Florida, 32159, United States

Location

K2 Medical Research - Maitland

Maitland, Florida, 32751, United States

Location

Progressive Medical Research - ClinEdge - PPDS

Port Orange, Florida, 32127, United States

Location

Axiom Brain Health LLC

Tampa, Florida, 33609, United States

Location

"Alzheimers Research and Treatment Center-Wellington "

Wellington, Florida, 33449, United States

Location

Conquest Research LLC - Winter Park - ClinEdge - PPDS

Winter Park, Florida, 32819, 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 Medical Research

Manhasset, New York, 11030, United States

Location

SUNY Upstate Medical Center

Syracuse, New York, 13210, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

Summit Research Network

Portland, Oregon, 97210, United States

Location

Instituto Privado Kremer

Córdoba, Córdoba Province, X5004AOA, Argentina

Location

Centro de Psiquiatria Biologica

Mendoza, Mendoza Province, 05500, Argentina

Location

KaRa Institute of Neurological Disease

Macquarie Park, New South Wales, 2113, Australia

Location

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

Alfred Health

Melbourne, Victoria, 3004, Australia

Location

Kawartha Regional Memory Clinic

Peterborough, Ontario, K9H 2P4, Canada

Location

Baycrest Health Sciences

Toronto, Ontario, M6A 2X8, Canada

Location

Universitätsklinikum Ulm-Oberer Eselsberg 45

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Klinikum rechts der Isar der Technischen Universitaet Muenchen

Munich, Bavaria, 81675, Germany

Location

Ambulantes Gesundheitszebtrum der Charite GmbH

Berlin, State of Berlin, 12200, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 13125, Germany

Location

Fondazione Policlinico Universitario A Gemelli-Rome

Rome, Lazio, 00168, Italy

Location

Azienda Policlinico Umberto

Rome, Lazio, 00185, Italy

Location

Ospedale Isola Tiberina - Gemelli Isola

Rome, Lazio, 00186, Italy

Location

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

Brescia, Lombardy, 25123, Italy

Location

IRCCS - Centro S. Giovanni di Dio Fatebene fratelli

Brescia, Lombardy, 25125, Italy

Location

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Lombardy, 20122, Italy

Location

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

Milan, Lombardy, 20133, Italy

Location

Azienda Ospedaliero-Universitaria di Modena - Policlinico di Modena

Modena, Modena, 41126, Italy

Location

ASL Biella - Ospedale degli Infermi

Ponderano, Piedmont, 13875, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Location

Brain Research Center Den Bosch - PPDS

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

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

Hospital de La Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

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

Barcelona, Barcelona, 8028, Spain

Location

Fundacion CITA Alzheimer Fundazioa

San Sebastián, Guipúzcoa, 20009, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, Madrid, 28034, Spain

Location

Hospital Universitario Doctor Peset

Valencia, Valencia, 46017, Spain

Location

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Valencia, 46026, Spain

Location

Centro De Atencion Especializada Oroitu

Getxo, Vizcaya, 48993, Spain

Location

Hospital Viamed Montecanal

Zaragoza, Zaragoza, 50012, Spain

Location

Re-Cognition Health - Bristol

Bristol, Bristol, BS32 4SY, United Kingdom

Location

RE: Cognition Health - Plymouth

Plymouth, Devon, PL6 8BT, United Kingdom

Location

Re:Cognition Health - Guildford - PPDS

Guildford, Surrey, GU2 7YD, United Kingdom

Location

Re:Cognition Health

London, W1G 9RU, United Kingdom

Location

The National Hospital for Neurology and Neurosurgery

London, WC1N 3BG, United Kingdom

Location

NeuroClin Glasgow

Motherwell, ML1 4UF, United Kingdom

Location

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

• TBD TBD

  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: January 19, 2023
• First Posted: February 27, 2023
• Study Start: January 4, 2023
• Primary Completion: January 31, 2025
• Study Completion: February 5, 2025
• Last Updated: February 25, 2026
• Results First Posted: February 25, 2026

Record last verified: 2026-02

Locations

AR (2); ES (8); GB (6); NL (1); PL (3); CA (2); US (15); IT (10); DE (4); AU (3)