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

Alector

Status and phase: Enrolling; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: AL002

Study type: Interventional

Funder types: Industry

Identifiers

NCT05744401

AL002-LTE

Details and patient eligibility

About

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

Full 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).

Enrollment: 210 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 3 patient groups

AL002 Dose 1

Experimental group

Description:

AL002 every 4 weeks

Treatment:

Drug: AL002

AL002 Dose 2

Experimental group

Description:

AL002 every 4 weeks

Treatment:

Drug: AL002

AL002 Dose 3

Experimental group

Description:

AL002 every 4 weeks

Treatment:

Drug: AL002