A Clinical Trial to Evaluate AL002 in Participants with Alzheimer's Disease
Research type
Research Study
Full title
A MULTICENTER, LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF AL002 IN PARTICIPANTS WITH ALZHEIMER'S DISEASE
IRAS ID
1006808
Contact name
Janel Boyce-Rustay
Contact email
Sponsor organisation
Alector, Inc.
Eudract number
2022-002987-57
Clinicaltrials.gov Identifier
Research summary
This is a Phase 2, randomized, parallel-group, long-term extension (LTE), dose-blind, multicentre study to evaluate the long-term safety and efficacy of AL002 [referred to as investigational medicinal product (IMP) in this AL002-LTE study] in participants with Alzheimer’s disease (AD). The study is a multicentre, global trial that will enrol participants who completed the planned treatment period in AL002-2 (parent study). This study is sponsored by Alector Inc. and the purpose of this study to see how safe and effective the experimental drug, AL002 is when given intravenously (IV) to participants with early AD.
AD is a degenerative brain disease and one of the most common causes of dementia. Over half a million people in the UK have dementia related to AD, which causes progressive memory loss and issues with cognitive function such as language, spatial awareness, organisation and concentration, as well as changes in mood. There is currently no effective treatment for AD.
AD is thought to be caused by the build-up of proteins in the brain, which clump together to form plaques (made up of amyloid protein) and tangles (made up of tau protein). The immune system plays an important role in clearing these proteins, but this becomes less effective with age. The study drug, AL002, binds to and stimulates cells in the immune system called microglia to help clear these proteins. This is the second clinical study using AL002; the first study in health volunteers and participants with Alzheimer's Disease indicated that the drug is safe and well tolerated.
Dose Blind means that the participants, study doctor, and all of the study team members and the Sponsor who are actively involved in the day-to-day activities of the study, will not know patient's dose assignment.
Dose Assignment means that if patients received AL002 during the AL002-2 study, they will remain at the same dose. If they received placebo during the AL002-2 study, they will receive AL002 in the LTE study.REC name
London - Chelsea Research Ethics Committee
REC reference
23/LO/0446
Date of REC Opinion
7 Jun 2023
REC opinion
Further Information Favourable Opinion