Clinical trial NCT05744401: A Long-term Extension Study to Evaluate Safety, Tolerability, and Efficacy of AL002 in Alzheimer's Disease
Official title: A Multicenter, Long-term Extension Study to Evaluate the Safety, Tolerability, and Efficacy of AL002 in Participants With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: Alector Inc.
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2023-02-27
Enrollment: 198
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Safety and tolerability as measured by number of/incidence of Adverse Events (AEs), including AESI and SAEs.
timeFrame: Through study completion, up to 49 weeks
measure: Safety and tolerability as measured by the number of incidence/MRI abnormalities.
timeFrame: Through study completion, up to 49 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Boca Raton
country: United States
facility: SFM Clinical Research, LLC
state: Florida
city: Lady Lake
country: United States
facility: Charter Research
state: Florida
city: Maitland
country: United States
facility: K2 Medical Research - Maitland
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research - ClinEdge - PPDS
state: Florida
city: Tampa
country: United States
facility: Axiom Brain Health LLC
state: Florida
city: Wellington
country: United States
facility: "Alzheimers Research and Treatment Center-Wellington "
state: Florida
city: Winter Park
country: United States
facility: Conquest Research LLC - Winter Park - ClinEdge - PPDS
state: Florida
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic
state: Mississippi
city: Neptune
country: United States
facility: Advanced Clinical Institute
state: New Jersey
city: Manhasset
country: United States
facility: Feinstein Institute For Medical Research
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical Center
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Portland
country: United States
facility: Summit Research Network
state: Oregon
city: Córdoba
country: Argentina
facility: Instituto Privado Kremer
state: Cordoba
city: Mendoza
country: Argentina
facility: Centro de Psiquiatria Biologica
city: Macquarie Park
country: Australia
facility: KaRa Institute of Neurological Disease
state: New South Wales
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Health
state: Victoria
city: Peterborough
country: Canada
facility: Kawartha Regional Memory Clinic
state: Ontario
city: Toronto
country: Canada
facility: Baycrest Health Sciences
state: Ontario
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm-Oberer Eselsberg 45
state: Baden-Württemberg
city: Muenchen
country: Germany
facility: Klinikum rechts der Isar der Technischen Universitaet Muenchen
state: Bayern
city: Berlin
country: Germany
facility: Ambulantes Gesundheitszebtrum der Charite GmbH
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Roma
country: Italy
facility: Azienda Policlinico Umberto
state: Lazio
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A Gemelli-Rome
state: Lazio
city: Rome
country: Italy
facility: Ospedale Isola Tiberina - Gemelli Isola
state: Lazio
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN
state: Lombardia
city: Brescia
country: Italy
facility: IRCCS - Centro S. Giovanni di Dio Fatebene fratelli
state: Lombardia
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
state: Lombardia
city: Milano
country: Italy
facility: Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-VIA MANGIAGALLI 3
state: Lombardia
city: Ponderano
country: Italy
facility: ASL Biella - Ospedale degli Infermi
state: Piemonte
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena - Policlinico di Modena
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: 's-Hertogenbosch
country: Netherlands
facility: Brain Research Center Den Bosch - PPDS
state: Noord-Brabant
city: Wroclaw
country: Poland
facility: NZOZ Wroclawskie Centrum Alzheimerowskie
state: Dolnoslaskie
city: Warszawa
country: Poland
facility: Centrum Medyczne NeuroProtect
state: Mazowieckie
city: Szczecin
country: Poland
facility: EUROMEDIS Sp. z o.o.
state: Zachodniopomorskie
city: San Sebastián
country: Spain
facility: Fundacion CITA Alzheimer Fundazioa
state: Guipúzcoa
city: Getxo
country: Spain
facility: Centro De Atencion Especializada Oroitu
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Fundacion ACE Instituto Catalan de Neurociencias-Gran via de Carles III, 85 bis
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
city: Zaragoza
country: Spain
facility: Hospital Viamed Montecanal
city: Plymouth
country: United Kingdom
facility: RE: Cognition Health - Plymouth
state: Devon
city: Guildford
country: United Kingdom
facility: Re:Cognition Health - Guildford - PPDS
state: Surrey
city: Bristol
country: United Kingdom
facility: Re-Cognition Health - Bristol
city: London
country: United Kingdom
facility: Re:Cognition Health
city: London
country: United Kingdom
facility: The National Hospital for Neurology and Neurosurgery
city: Motherwell
country: United Kingdom
facility: NeuroClin Glasgow
Study officials:
name: TBD TBD
role: PRINCIPAL_INVESTIGATOR
References: