Alector has completed the patient enrolment in the Phase II INVOKE-2 clinical trial of AL002 to treat early Alzheimer’s disease (AD).
The multi-centre, dose-ranging, placebo-controlled, randomised, double-blind study will be carried out at various sites across 11 countries.
It intends to assess the efficacy and safety of the humanised monoclonal antibody (mAb) AL002 in slowing the progression of Alzheimer’s.
Patients will be randomised to receive AL002 or placebo intravenously every four weeks for up to 96 weeks.
The same regimen will be followed for all the participants until the last one completes 48 weeks of treatment. The design is intended to capture more observations for the primary analysis.
The primary endpoint of the study is disease progression, as measured by the Clinical Dementia Rating Sum of Boxes (CDR-SB) that assesses both cognitive and functional domains.
Other multiple clinical and functional outcome assessments are also planned during the study period.
In addition, the trial will assess microglial activation and Alzheimer’s pathophysiology using cerebrospinal fluid and plasma biomarkers.
The biomarkers will also be used during amyloid beta and tau positron emission tomography imaging, and brain magnetic resonance imaging.
Alector CEO Arnon Rosenthal said: “We are also encouraged to see that nearly all eligible participants are rolling over into the long-term extension of the INVOKE-2 trial, which will enable us to better understand the long-term effects of this potential therapeutic.
“Notably, results from a Phase I clinical trial of AL002 in healthy volunteers demonstrated both dose dependent target engagement and activation of microglia.
“We look forward to an INVOKE-2 data readout in the fourth quarter of 2024, which will inform a potential pivotal Phase III clinical development programme for AL002 that enables registration.”
AL002 targets triggering receptor expressed on myeloid cells 2 to improve cell survival and microglia activity. It is being developed in collaboration with AbbVie.
