Alector has commenced a Phase l INFRONT trial to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AL001 for the treatment of patients with Frontotemporal Dementia With Granulin Mutation (FTD-GRN).
The randomised, parallel assignment trial intends to enrol 60 participants, including both healthy subjects and FTD-GRN patients.
During the trial, subjects will receive up to five single-ascending doses of AL001. Each cohort will also receive saline solution as a single infusion in a ratio of six active and two placebo subjects.
The trial’s primary goal is to determine safety and tolerability of AL001 measured by number of subjects with adverse events and dose-limiting adverse event (DLAEs).
Its secondary goals include pharmacokinetics, maximum plasma concentration, and area under the curve concentration (AUC).
Alector chief medical officer Robert Paul said: “Our clinical trials are anchored in state-of-the-art biomarkers, brain imaging modalities, and cognitive tests that will allow us to monitor disease progression and treatment response rapidly and accurately.
“We look forward to progressing AL001 through clinical development towards our goal of bringing a new treatment option to patients in need.”
Frontotemporal dementia (FTD) is a common form of dementia that usually affects individuals who are less than 65 years old.
FTD is estimated to affect 65,000 individuals in the US and 110,000 individuals across the European Union.
The rapidly progressing degenerative syndrome results in prominent cognitive dysfunction, behavioural and personality changes, and language deficits.