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

A

Alector

Status and phase

Active, not recruiting
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

188 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

188 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

Trial contacts and locations

54

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Central trial contact

Study Lead

Data sourced from clinicaltrials.gov

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