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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05744401
• Other study ID #: AL002-LTE
• Status: Recruiting
• Phase: Phase 2
• Start date: January 4, 2023
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Alector Inc.
• Contact: Study Lead
• Phone: 650-826-2454
• Email: clinicaltrials[@]alector.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: December 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• AL002
Administered via intravenous (IV) infusion

Locations

Country	Name	City	State
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	KaRa Institute of Neurological Disease	Macquarie Park	New South Wales
Canada	Kawartha Regional Memory Clinic	Peterborough	Ontario
Germany	Klinikum rechts der Isar der Technischen Universitaet Muenchen	Muenchen	Bayern
Italy	ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN	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	Azienda Ospedaliero Universitaria Pisana	Pisa
Italy	Azienda Policlinico Umberto	Roma	Lazio
Poland	EUROMEDIS Sp. z o.o.	Szczecin	Zachodniopomorskie
Poland	Centrum Medyczne NeuroProtect	Warszawa	Mazowieckie
Poland	NZOZ Wroclawskie Centrum Alzheimerowskie	Wroclaw	Dolnoslaskie
Spain	Fundacion ACE Instituto Catalan de Neurociencias-Gran via de Carles III, 85 bis	Barcelona
Spain	Hospital de La Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Fundacion CITA Alzheimer Fundazioa	San Sebastián	Guipúzcoa
Spain	Hospital Universitari i Politecnic La Fe de Valencia	Valencia
Spain	Hospital Universitario Doctor Peset	Valencia
Spain	Hospital Viamed Montecanal	Zaragoza
United Kingdom	Re:Cognition Health	London
United Kingdom	The National Hospital for Neurology and Neurosurgery	London
United Kingdom	RE: Cognition Health - Plymouth	Plymouth	Devon
United States	Hattiesburg Clinic	Hattiesburg	Mississippi
United States	Charter Research	Lady Lake	Florida
United States	Advanced Clinical Institute	Neptune	New Jersey
United States	Banner Alzheimer's Institute	Phoenix	Arizona
United States	Summit Research Network	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Alector Inc.	AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability as measured by number of/incidence of Adverse Events (AEs), including AESI and SAEs.		Through study completion, up to 49 weeks
Primary	Safety and tolerability as measured by the number of incidence/MRI abnormalities.		Through study completion, up to 49 weeks