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

Primary Purpose

Alzheimer's Disease

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AL002
Sponsored by
Alector Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Charter ResearchRecruiting
  • Hattiesburg ClinicRecruiting
  • Advanced Clinical InstituteRecruiting
  • Summit Research NetworkRecruiting
  • KaRa Institute of Neurological DiseaseRecruiting
  • Box Hill HospitalRecruiting
  • ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PINRecruiting
  • NZOZ Wroclawskie Centrum AlzheimerowskieRecruiting
  • Centrum Medyczne NeuroProtect
  • EUROMEDIS Sp. z o.o.Recruiting
  • Hospital de La Santa Creu i Sant PauRecruiting
  • Fundacion ACE Instituto Catalan de Neurociencias-Gran via de Carles III, 85 bisRecruiting
  • Hospital Universitario Doctor PesetRecruiting
  • Hospital Viamed Montecanal
  • Re:Cognition Health
  • The National Hospital for Neurology and Neurosurgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

AL002 Dose 1

AL002 Dose 2

AL002 Dose 3

Arm Description

AL002 every 4 weeks

AL002 every 4 weeks

AL002 every 4 weeks

Outcomes

Primary Outcome Measures

Safety and tolerability as measured by number of/incidence of Adverse Events (AEs), including AESI and SAEs.
Safety and tolerability as measured by the number of MRI abnormalities.
Effect of Immunogenicity as measured by ADAs titers.

Secondary Outcome Measures

Full Information

First Posted
January 19, 2023
Last Updated
September 18, 2023
Sponsor
Alector Inc.
Collaborators
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT05744401
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2023 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alector Inc.
Collaborators
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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, randomized, parallel-group, long-term extension (LTE), dose-blind, multicenter 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AL002 Dose 1
Arm Type
Experimental
Arm Description
AL002 every 4 weeks
Arm Title
AL002 Dose 2
Arm Type
Experimental
Arm Description
AL002 every 4 weeks
Arm Title
AL002 Dose 3
Arm Type
Experimental
Arm Description
AL002 every 4 weeks
Intervention Type
Drug
Intervention Name(s)
AL002
Intervention Description
Administered via intravenous (IV) infusion
Primary Outcome Measure Information:
Title
Safety and tolerability as measured by number of/incidence of Adverse Events (AEs), including AESI and SAEs.
Time Frame
Through study completion, up to 49 weeks
Title
Safety and tolerability as measured by the number of MRI abnormalities.
Time Frame
Through study completion, up to 49 weeks
Title
Effect of Immunogenicity as measured by ADAs titers.
Time Frame
Through study completion, up to 49 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Lead
Phone
650-826-2454
Email
clinicaltrials@alector.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TBD TBD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charter Research
City
Lady Lake
State/Province
Florida
ZIP/Postal Code
32159
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Hattiesburg Clinic
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Advanced Clinical Institute
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Summit Research Network
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
KaRa Institute of Neurological Disease
City
Macquarie Park
State/Province
New South Wales
ZIP/Postal Code
2113
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study co Coordinator
Facility Name
NZOZ Wroclawskie Centrum Alzheimerowskie
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
53-110
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Centrum Medyczne NeuroProtect
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-684
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
EUROMEDIS Sp. z o.o.
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
70-111
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Hospital de La Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Fundacion ACE Instituto Catalan de Neurociencias-Gran via de Carles III, 85 bis
City
Barcelona
ZIP/Postal Code
8028
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Hospital Universitario Doctor Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Hospital Viamed Montecanal
City
Zaragoza
ZIP/Postal Code
50012
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Re:Cognition Health
City
London
ZIP/Postal Code
W1G 9RU
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
The National Hospital for Neurology and Neurosurgery
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

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

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