Alector has started a Phase I INVOKE clinical study to evaluate AL002 for the treatment of Alzheimer’s disease.
The trial will investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of single and multiple doses of AL002 in healthy adults and in patients with mild to moderate Alzheimer’s disease.
Approximately 52 patients are expected to be enrolled in the first in human (FIH), randomised, double-blind, placebo-controlled trial.
The trial includes single ascending dose (SAD) and multiple-dose (MD) phases.
Up to 40 healthy adult participants will be sequentially included in up to five cohorts for the SAD phase.
In the MD phase, nearly 12 patients with mild to moderate Alzheimer’s disease will be recruited in one cohort.
The trial’s primary endpoint is safety and tolerability, as measured by the number of subjects with adverse events and dose-limiting adverse event (DLAEs).
Its secondary endpoints include PK, maximum plasma concentration (Cmax), and area under the curve concentration (AUC).
Alector co-founder and CEO Arnon Rosenthal said: “At Alector, we believe that Alzheimer’s disease is caused by a dysfunctional brain immune system that due to aging or genetic mutations, fails to clear pathological proteins, nourish nerve and glial cells, and promote neuronal connections.
“We designed AL002 to modulate TREM2, which we believe may rejuvenate the aging brain immune system and provide a comprehensive therapy to slow or stop disease progression in patients with Alzheimer’s disease.
“The AL002 programme is our second immuno-neurology programme in the clinic that aims to leverage the immune system to cure degenerative brain disorders.”
Alzheimer’s is a degenerative brain disease and the most common type of dementia. It mostly affects people in their mid-60s.