Deena Beasley
SAN DIEGO, Dec 2 (Reuters) – Novo Nordisk launched a pivotal trial of its GLP-1 drug semaglutide in Alzheimer’s patients in 2020 based on findings from human, animal and real-world studies, a Novo Nordisk executive said on Tuesday, acknowledging criticism that the Novo Nordisk study had design flaws.
Although the trials failed to show a statistically significant slowing of cognitive decline in patients taking the drug, “we still believe this is the right decision… It’s a scientific question that needs an answer,” Peter Johannsen, vice president of medicine at Novo Nordisk International, said in remarks at the Alzheimer’s Disease Clinical Trials Conference in San Diego.
Data now consolidated on the Novo website show evidence that the GLP-1 hormone is involved in neurotransmission and has multiple effects throughout the brain, he said.
While Alzheimer’s is defined by the presence of toxic amyloid plaques in the brain, “there are still things we don’t know” about the pathology of the disease, Johnson said. “It’s a very complex disease with a lot of different genetic signatures going on.”
Novo is set to release preliminary results on Wednesday from two 2-year studies testing Novo’s GLP-1 diabetes drug Rybelsus against a placebo in nearly 4,000 Alzheimer’s patients.
Full results will be presented at another medical meeting in March. The company issued a brief press release last week saying the studies did not meet their goals.
Cognitive benefits for people with diabetes
Johannsen said retrospective studies have shown cognitive benefits for people with diabetes from the use of GLP-1, which was originally approved for blood sugar control. The effects were significant after about a year of treatment and increased with long-term use.
Some of the analyzes did not specify which type of dementia the patients had. Some real-world evidence is based on clinical diagnosis of Alzheimer’s disease rather than more accurate testing and identification of amyloid plaques.
According to the Alzheimer’s Association, about 60 percent of people with dementia have Alzheimer’s disease, with the remaining cases caused by blood vessel or other problems.
Johansen points to potential “biases” in real-world analyses. People with diabetes who take GLP-1 may have access to an endocrinologist, not just primary care, and may belong to a higher socioeconomic group than the general population, he said.
He said patients who receive GLP-1 to treat diabetes may have better glycemic and metabolic control than those who do not receive treatment, which may delay them from seeking further help and being diagnosed with dementia.
(Reporting by Deena Beasley; Editing by Bill Burkrot)
