Alzheimer's drug AL002 safety trial ends early
NCT ID NCT05744401
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study was a long-term extension of an earlier trial, testing the safety and tolerability of AL002 in 197 people with early Alzheimer's disease. Participants received the drug by IV infusion. The trial was terminated, meaning it stopped before completion, so the full safety and effectiveness data are not available. The main goal was to monitor side effects, including brain abnormalities like swelling or small bleeds.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AL002 (a drug given by IV infusion)
- What this could lead to
- If successful, this could help confirm whether AL002 is safe enough to continue testing as a potential treatment for early Alzheimer's disease.
- What could go wrong
- The trial was terminated early, so results are limited. AL002 is still experimental, and previous studies have not yet proven it slows or stops Alzheimer's. Brain swelling or bleeding (ARIA) are known risks with similar drugs.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
197 people
The number who actually took part.
- Started
-
Jan 2023
- Finished
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Feb 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
50 to 85 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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"Alzheimers Research and Treatment Center-Wellington "
Wellington, Florida, 33449, United States
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ASL Biella - Ospedale degli Infermi
Ponderano, Piedmont, 13875, Italy
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ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN
Brescia, Lombardy, 25123, Italy
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Advanced Clinical Institute
Neptune City, New Jersey, 07753, United States
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Alfred Health
Melbourne, Victoria, 3004, Australia
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Ambulantes Gesundheitszebtrum der Charite GmbH
Berlin, State of Berlin, 12200, Germany
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Axiom Brain Health LLC
Tampa, Florida, 33609, United States
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Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
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Azienda Ospedaliero-Universitaria di Modena - Policlinico di Modena
Modena, Modena, 41126, Italy
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Azienda Policlinico Umberto
Rome, Lazio, 00185, Italy
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Banner Alzheimer's Institute
Phoenix, Arizona, 85006, United States
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Baycrest Health Sciences
Toronto, Ontario, M6A 2X8, Canada
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Box Hill Hospital
Box Hill, Victoria, 3128, Australia
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Brain Research Center Den Bosch - PPDS
's-Hertogenbosch, North Brabant, 5223 LA, Netherlands
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Centro De Atencion Especializada Oroitu
Getxo, Vizcaya, 48993, Spain
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Centro de Psiquiatria Biologica
Mendoza, Mendoza Province, 05500, Argentina
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Centrum Medyczne NeuroProtect
Warsaw, Masovian Voivodeship, 01-684, Poland
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Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 13125, Germany
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Charter Research
Lady Lake, Florida, 32159, United States
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Conquest Research LLC - Winter Park - ClinEdge - PPDS
Winter Park, Florida, 32819, United States
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EUROMEDIS Sp. z o.o.
Szczecin, West Pomeranian Voivodeship, 70-111, Poland
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Feinstein Institute For Medical Research
Manhasset, New York, 11030, United States
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Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122, Italy
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Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-VIA MANGIAGALLI 3
Milan, Lombardy, 20133, Italy
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Fondazione Policlinico Universitario A Gemelli-Rome
Rome, Lazio, 00168, Italy
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Fundacion ACE Instituto Catalan de Neurociencias-Gran via de Carles III, 85 bis
Barcelona, Barcelona, 8028, Spain
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Fundacion CITA Alzheimer Fundazioa
San Sebastián, Guipúzcoa, 20009, Spain
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Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
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Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
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Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Valencia, 46026, Spain
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Hospital Universitario Doctor Peset
Valencia, Valencia, 46017, Spain
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Hospital Universitario Ramon y Cajal
Madrid, Madrid, 28034, Spain
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Hospital Viamed Montecanal
Zaragoza, Zaragoza, 50012, Spain
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Hospital de La Santa Creu i Sant Pau
Barcelona, Barcelona, 08025, Spain
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IRCCS - Centro S. Giovanni di Dio Fatebene fratelli
Brescia, Lombardy, 25125, Italy
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Instituto Privado Kremer
Córdoba, Córdoba Province, X5004AOA, Argentina
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K2 Medical Research - Maitland
Maitland, Florida, 32751, United States
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KaRa Institute of Neurological Disease
Macquarie Park, New South Wales, 2113, Australia
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Kawartha Regional Memory Clinic
Peterborough, Ontario, K9H 2P4, Canada
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Klinikum rechts der Isar der Technischen Universitaet Muenchen
Munich, Bavaria, 81675, Germany
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NZOZ Wroclawskie Centrum Alzheimerowskie
Wroclaw, Lower Silesian Voivodeship, 53-110, Poland
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NeuroClin Glasgow
Motherwell, ML1 4UF, United Kingdom
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Ospedale Isola Tiberina - Gemelli Isola
Rome, Lazio, 00186, Italy
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Progressive Medical Research - ClinEdge - PPDS
Port Orange, Florida, 32127, United States
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RE: Cognition Health - Plymouth
Plymouth, Devon, PL6 8BT, United Kingdom
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Re-Cognition Health - Bristol
Bristol, Bristol, BS32 4SY, United Kingdom
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Re:Cognition Health
London, W1G 9RU, United Kingdom
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Re:Cognition Health - Guildford - PPDS
Guildford, Surrey, GU2 7YD, United Kingdom
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SFM Clinical Research, LLC
Boca Raton, Florida, 33487, United States
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SUNY Upstate Medical Center
Syracuse, New York, 13210, United States
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Summit Research Network
Portland, Oregon, 97210, United States
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The National Hospital for Neurology and Neurosurgery
London, WC1N 3BG, United Kingdom
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University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
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Universitätsklinikum Ulm-Oberer Eselsberg 45
Ulm, Baden-Wurttemberg, 89081, Germany
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