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

Phase 2

Terminated

• Conditions: Alzheimer's Disease
• Interventions: Drug: AL002

• Registration Number: NCT05744401
• Lead Sponsor: Alector Inc.

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).

Study Timeline

• Study Start: 2023-01-04
• Study First Submitted: 2023-01-19
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-27
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 198

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AL002 Dose 3	AL002	AL002 every 4 weeks
AL002 Dose 1	AL002	AL002 every 4 weeks
AL002 Dose 2	AL002	AL002 every 4 weeks

Primary Outcome Measures

Name	Time	Method
Safety and tolerability as measured by the number of incidence/MRI abnormalities.	Through study completion, up to 49 weeks
Safety and tolerability as measured by number of/incidence of Adverse Events (AEs), including AESI and SAEs.	Through study completion, up to 49 weeks

Trial Locations

Locations (54)

Banner Alzheimer's Institute; 🇺🇸 Phoenix, Arizona, United States

Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States

SFM Clinical Research, LLC; 🇺🇸 Boca Raton, Florida, United States

Charter Research; 🇺🇸 Lady Lake, Florida, United States

K2 Medical Research - Maitland; 🇺🇸 Maitland, Florida, United States

Progressive Medical Research - ClinEdge - PPDS; 🇺🇸 Port Orange, Florida, United States

Axiom Brain Health LLC; 🇺🇸 Tampa, Florida, United States

"Alzheimers Research and Treatment Center-Wellington "; 🇺🇸 Wellington, Florida, United States

Conquest Research LLC - Winter Park - ClinEdge - PPDS; 🇺🇸 Winter Park, Florida, United States

Hattiesburg Clinic; 🇺🇸 Hattiesburg, Mississippi, United States

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