A Continuation Study of Latozinemab in Participants with Neurodegenerative Disease
Research type
Research Study
Full title
A Continuation Study of Latozinemab in Participants with Neurodegenerative Disease
IRAS ID
1008831
Contact name
Janel Boyce-Rustay
Contact email
Sponsor organisation
Alector Inc.
Research summary
This is an open-label continuation study of latozinemab in participants with neurodegenerative disease. The purpose of the study is to provide continued access to latozinemab in participants who have completed a parent latozinemab study. The study will assess safety and tolerability when participants are administered latozinemab 60mg/kg intravenously every 4 weeks.
AL001-2 & AL001-3 are the previous studies with latozinemab in the UK. AL001-2 is an ongoing Phase 2 study and AL001-3 is an ongoing Phase 3 study.
Latozinemab is a new, experimental medicine, which means that it has not been approved yet by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Latozinemab, also known as AL001, is under development for the treatment of Frontotemporal dementia (FTD) and amyotrophic lateral sclerosis (ALS). Frontotemporal dementia (FTD) is a rare, early-onset form of dementia. PGRN protein deficiency is common in individuals with FTD, and mutations in the progranulin gene (GRN) can cause a >50% reduction in secreted functional PGRN. ALS is a rare, progressive neurodegenerative disorder affecting the motor neurons in the brain and spinal cord, ultimately leading to paralysis and death from respiratory failure. There is increasing evidence of not only a clinical co-occurrence of FTD and ALS, but a genetic overlap between the 2 conditions.
As this is a continuation study, the number of planned sites will be based on the number of sites who have eligible participants who have completed a prior study of latozinemab, and the willingness of the study site(s) to participate in this continuation study. Safety assessments include monitoring adverse events, physical examinations, neurological examinations, vital signs & weight, ECGs, clinical laboratory analysis in blood and urine and suicidality assessments and Anti-Drug Antibodies throughout the study.
The study is sponsored by Alector, Inc.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
23/NE/0203
Date of REC Opinion
15 Dec 2023
REC opinion
Further Information Favourable Opinion