K2 Medical Research is recruiting for a Phase 2 trial of Alector and Abbvie’s new experimental Alzheimer’s drug, AL002.
K2 is screening possible trial participants for a Phase 2 clinical trial of an Alzheimer’s drug called AL002. This antibody drug is designed to activate a receptor in the brain called TREM2. TREM2 is important because it lives on the brain’s resident immune cells, the microglia. Other recent Alzheimer’s drug breakthroughs, like lecanemab and Aduhelm, target Alzheimer’s best known biomarker, beta-amyloid protein, directly. AL002 takes a different approach to get to these protein plaques: Instead it triggers these microglia cells in order to spur an immune response, which the research teams at Alector and Abbvie believe will prompt microglia to clear the amyloid plaques on their own.
The drugmakers hope this new approach will revolutionize Alzheimer’s treatment. This trial to determine AL002’s efficacy is now recruiting 265 participants between the ages of 50 and 85 with symptoms of early Alzheimer’s disease.
What to expect from the trial screening process
According to K2 Med project manager Joshua Bowman, the first step to joining this trial is to determine whether a candidate has early, symptomatic Alzheimer’s disease. This eligibility screening process will take about eight weeks, Bowman said.
During this time, candidates will receive genetic testing to determine ApoE4 status. Researchers will also carry out tests to assess amyloid in their blood and amyloid PET scans to confirm the findings. The cost of these procedures are covered by the trial administrators.
What to expect from the trial
The trial will test three different doses of AL002, comparing them to a placebo. People who are selected for the trial will be randomized across four study groups; 75 percent of participants will receive the treatment, and the remainder will receive a placebo.
Over the course of the study, which will last 96 weeks (or, just under two years) participants will receive infusions of either AL002 or a placebo, depending on their randomized group, once every four weeks. Participants will also undergo four eye exams and seven MRI scans.
Bowman explained that the drug may cause swelling of the colored portion of the eye, a condition called uveitis, caused by inflammation inside your eye, typically seen when the immune system is fighting an infection, causing eye redness, and dull pain. The eye scans will monitor for this condition.
The study will also use various cognitive assessments to measure whether AL002 can help to slow the progression of Alzheimer’s disease through the brain.
What to know about microglia-based Alzheimer’s treatments like AL002
The majority of Alzheimer’s drug trials of late have been focused on removing these toxic beta-amyloid proteins, which build up into plaques, from the brain. Drugs like lecanemab (which is seeking possible FDA approval in early 2023), gantenerumab (which recently failed its Phase 3 clinical trials) and aducanumab (Aduhelm, approved by the FDA in summer 2021 despite controversy over its efficacy) were all designed to target these proteins.
AL002’s trial is the first antibody-based drug targeting, instead, this TREM2 receptor.
Ready to learn more?
“The first step towards getting involved with this study is to schedule a memory screen,” Bowman said — the first component in the eligibility screening process.
The principal investigator for the trial is Dr. Brandon Lenox. Call K2 to learn more: 407-500-K2K2 (x5252).
