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

• Sponsor: Alector Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05744401
• Collaborator: AbbVie (Industry)
• Enrollment: 190
• Locations: 3
• Arms: 3
• Anticipated Duration (Months): 34.9
• Patients Per Site: 63.3
• Patients Per Site Per Month: 1.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease	Drug: AL002	Phase 2

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).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 190 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Long-term Extension Study to Evaluate the Safety, Tolerability, and Efficacy of AL002 in Participants With Alzheimer's Disease
• Actual Study Start Date: Jan 4, 2023
• Anticipated Primary Completion Date: Sep 1, 2025
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AL002 Dose 1 AL002 every 4 weeks	Drug: AL002; Administered via intravenous (IV) infusion
Experimental: AL002 Dose 2 AL002 every 4 weeks	Drug: AL002; Administered via intravenous (IV) infusion
Experimental: AL002 Dose 3 AL002 every 4 weeks	Drug: AL002; Administered via intravenous (IV) infusion

Outcome Measures

Primary Outcome Measures

1. Safety and tolerability as measured by number of/incidence of Adverse Events (AEs), including AESI and SAEs. [Through study completion, up to 49 weeks]

2. Safety and tolerability as measured by the number of MRI abnormalities. [Through study completion, up to 49 weeks]

3. Effect of Immunogenicity as measured by ADAs titers. [Through study completion, up to 49 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hattiesburg Clinic	Hattiesburg	Mississippi	United States	39401
2	Advanced Clinical Institute	Neptune	New Jersey	United States	07753
3	Summit Research Network	Portland	Oregon	United States	97210

Sponsors and Collaborators

• Alector Inc.
• AbbVie

Investigators

• Principal Investigator: TBD TBD,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alector Inc.
• ClinicalTrials.gov Identifier: NCT05744401
• Other Study ID Numbers: AL002-LTE
• First Posted: Feb 27, 2023
• Last Update Posted: Feb 27, 2023
• Last Verified: Feb 1, 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alzheimer Disease

Study Results

No Results Posted as of Feb 27, 2023