Alzheimer’s pill could reduce brain decline in some high-risk patients, trial suggests
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New research suggests that an experimental pill could slow memory loss and brain shrinkage in some Alzheimer’s patients.
The pill, called ALZ-801 (valyltramiprosate), was shown to be effective in people with early Alzheimer’s disease and two copies of the APOE4 gene, increasing the risk of Alzheimer’s by 10 times.
Researchers at Alzheon, Inc., a Massachusetts biotechnology company, conducted a Phase 3 trial that included 325 people with early Alzheimer’s (either mild cognitive impairment (MCI) or mild dementia), all of whom carried the APOE4 gene, according to a press release.
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The participants, whose ages ranged from 50 to 80, randomly received ALZ-801 pills or a placebo for about 18 months.
In the overall group, ALZ-801 showed some memory slowing and cognitive impairment, but the difference was not statistically significant.
New research suggests that an experimental pill could slow memory loss and brain shrinkage in some Alzheimer’s patients. (iStock)
However, only in people with the early stages of Alzheimer’s who had mild cognitive impairment, the pill appeared to slow memory decline by 50% and stop almost all daily cognitive decline.
“People diagnosed with mild cognitive impairment experience a decline in cognitive abilities, including memory, language, or visual/spatial perception; however, they maintain the ability to independently perform most activities of daily living,” Christopher Weber, Ph.D., senior director of global scientific initiatives at the Alzheimer’s Association in Chicago, who was not part of the study, told News Digital.
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People who took the pill twice a day also had slower brain contraction; Particularly in the hippocampus, which controls memory and thinking, atrophy was about 18% less than in those who took the placebo.
The results were published in the medical journal Drugs.
The pill, called ALZ-801 (valyltramiprosate), was shown to be effective in people with early Alzheimer’s disease and two copies of the APOE4 gene, increasing the risk of Alzheimer’s by 10 times. (iStock)
According to the researchers, the main side effects reported included nausea, vomiting and appetite suppression.
The experimental pill could eventually serve as a homemade alternative to the currently approved Alzheimer’s drugs lecanemab or donanemab, both of which require intravenous infusions.
“It may very well have a future as part of the growing arsenal of anti-Alzheimer’s drugs.”
Current drugs, which are monoclonal antibody treatments designed to break down amyloid plaques in the brain, have also been linked to brain inflammation and bleeding. That side effect was not seen with ALZ-801, which works by preventing amyloid plaques from forming in the first place.
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“In this trial, the fact that APOE-ε4/ε4 individuals did not show increased bleeding or brain swelling is encouraging, and suggests that this drug may be relatively safe in a population that is otherwise at higher risk for side effects,” Weber noted.
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News senior medical analyst Dr. Marc Siegel echoed this advantage.
“This medication can be given before plaques fully form, so prevention may be a goal,” Siegel, who was also not involved in the study, told News Digital. “As a result, we don’t see the brain inflammation that is sometimes a side effect of monoclonal antibodies that dissolve plaque.”
Currently available Alzheimer’s drugs, which are monoclonal antibody treatments designed to break down amyloid plaques in the brain, have been linked to inflammation and bleeding in the brain. (iStock)
The study had some limitations, the researchers noted, primarily that the strongest results were only seen in the earliest stage group and not in all participants.
The trial also included only carriers of the APOE4 gene, which comprises about 15% of Alzheimer’s patients.
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The study was also relatively short, and longer follow-up trials were needed to confirm the results.
Weber reiterated that the primary and secondary results of the trial were negative.
“That said, follow-up analyzes with specific subgroups were encouraging, including the fact that the treatment caused a significant slowing of contraction in the hippocampus, which is a section of the brain that plays a very important role in memory,” he told News Digital.
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An encouraging aspect of this experimental drug, according to Weber, is its potential to complement other drugs that treat early Alzheimer’s disease.
“This treatment could potentially be used in combination with other anti-amyloid treatments, although more evidence is needed to understand how this drug could be used as part of a combination therapy,” he said.
“This treatment could potentially be used in combination with other anti-amyloid treatments, although more evidence is needed to understand how this drug could be used as part of a combination therapy,” one expert said. (iStock)
“Given the relatively small size of this subgroup, it will be important to validate these findings in larger, longer clinical trials.”
Siegel agreed that the drug could have potential. “It may very well have a future as part of the growing arsenal of anti-Alzheimer’s drugs, which target several different prevention targets, including beta amyloid and tau plaques, as well as neuroinflammation,” he said.
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The study was funded by Alzheon, Inc., manufacturer of ALZ-801, and supported by a grant from the US National Institute on Aging.
Melissa Rudy is a senior health editor and member of the lifestyle team at News Digital. Story tips can be sent to melissa.rudy@News.com.