Immunotherapy is the latest Alzheimer’s treatment that is gaining momentum in scientific research. These drugs which typically end with the suffix -mab are short for monoclonal antibodies, which are laboratory-made proteins that mimic the immune system’s defensive abilities.
Aduhelm, the Biogen and Eisai drug, has been making headlines for the Food and Drug Administration’s recent approval late last month. The pharma companies are co-developing another -mab drug, lecanemab, which after the approval of Aduhelm, has also been granted breakthrough status by the FDA.
These immunotherapies are designed to slow down the progression of Alzheimer’s disease and are being tested on earlier stage patients. Lecanemab is an antibody that is administered directly into the bloodstream in order to bind to a soluble, damaging version of the amyloid protein.
The FDA decided to speed up the agency’s evaluation process of Biogen and Eisai’s lecanemab after reviewing what it considered promising data from a Phase 2-B clinical trial. The trial tested lecanemab’s ability to reduce aggregations of beta-amyloid in the brain — like Aduhelm is designed to — and to reduce clinical decline among the trial’s 856 patients, who had early signs of Alzheimer’s including mild cognitive impairment and early amyloid pathology.
The trial results, presented at the 2021 Alzheimer’s Disease and Parkinson’s Disease Conference, indicate the drug did help clear beta-amyloid from the brain. The drug is now in Phase 3 trials, being tested across 1,795 patients with early Alzheimer’s.
Dr. Jeffrey Norton, principal investigator at Charter Research, describes Aduhelm and lecanemab as “cousins,” since they have similar qualities, but are different in makeup: Aduhelm is designed to target a key Alzheimer’s biomarker called beta-amyloid plaque directly, while lecanemab targets large oligomers — toxins that are said to lead to neuron damage and therefore Alzheimer’s disease — an earlier form of amyloid plaques.
"Amyloid plaque deposition is believed to be the underlying reason for memory loss in Alzheimer's disease. Removing plaque appears to correlate with slowing the progression of cognitive decline in these patients," Dr. Norton said.
Aduhelm was the first Alzheimer’s drug approved in the last two decades, and the only disease-modifying drug ever approved, despite the ever growing Alzheimer’s epidemic. With other immunotherapies being given breakthrough status, it is hoped that this type of research can pave the way for more drug therapies designed to catch Alzheimer’s at an earlier stage and slow down its progression.
“The reality is that lecanemab is one of the first drugs to have solid evidence of modifying the progression of Alzheimer’s disease, and this is something we have waited decades for,” Dr. Norton said.
Lecanemab is under study now through a public-private partnership between Eisai, Biogen, the Alzheimer’s Clinical Trials Consortium (ACTC), and the National Institute on Aging (NIA), with shared leadership responsibility across Eisai and ACTC. The study of lecanemab is called the "AHEAD" study, and it's being conducted at 102 clinical trials centers in 8 countries around the world. One of the trial locations chosen to conduct the study is Charter Research in Winter Park, FL.
The study is open to people 55 to 80 years of age who have normal cognition (no signs of memory loss or other Alzheimer’s symptoms), but elevated levels of brain amyloid. Study participants have their amyloid pathology confirmed with a PET scan, then receive either lecanemab or placebo, and are followed for 4 years. The study is designed to show if the clearance of aggregated forms of amyloid (via infusion of lecanemab) can effectively slow the progression of Alzheimer’s disease and whether it can delay — or prevent entirely — the onset of cognitive decline.
To learn if you're eligible to participate in the AHEAD study, call Charter Research now at 407-337-1000.