{"id":39364,"date":"2021-10-20T09:04:17","date_gmt":"2021-10-20T15:04:17","guid":{"rendered":"https:\/\/www.uchealth.org\/today\/?p=39364"},"modified":"2023-03-03T09:58:51","modified_gmt":"2023-03-03T16:58:51","slug":"scientists-launch-follow-on-study-to-understand-leukines-effectiveness-in-helping-alzheimers-patients","status":"publish","type":"post","link":"https:\/\/www.uchealth.org\/today\/scientists-launch-follow-on-study-to-understand-leukines-effectiveness-in-helping-alzheimers-patients\/","title":{"rendered":"Scientists launch follow-on study to understand Leukine’s effectiveness in helping Alzheimer’s patients"},"content":{"rendered":"
<\/div>

Call it Leukine. Call it sargramostim. Call it, if you dare, granulocyte-macrophage colony stimulating factor (GM-CSF).<\/p>\n

Whatever you call it, the little-prescribed drug approved 30 years ago to boost white blood cell production among bone-marrow transplant patients shows increasing promise as a therapy with the potential to not only stop \u2013 but perhaps even reverse \u2013 the ravages of Alzheimer\u2019s disease.<\/p>\n

That\u2019s what the latest work of a University of Colorado School of Medicine team that has been testing the drug (let\u2019s call it Leukine) for more than a decade has found. The team, led by neuroscientist Huntington Potter, the director of the University of Colorado Alzheimer\u2019s and Cognition Center<\/a>, reported evidence that Leukine helps the body clear out protein tangles and other hallmarks of Alzheimer\u2019s disease and improves brain function among those given the drug. Patients from UCHealth Neurology Clinic \u2013 Central Park<\/a> were central to the study\u2019s success, and they will also be indispensable to a longer-term follow-up study that\u2019s about to launch.<\/p>\n

\":
University of Colorado School of Medicine and UCHealth Neurologist Dr. Jonathan Woodcock, left, with CU School of Medicine neuroscientists Tim Boyd and Huntington Potter in 2016. The three worked for years laying the groundwork for a long-term Alzheimer\u2019s drug study set to launch in May. Photo by Todd Neff for UCHealth.<\/figcaption><\/figure>\n

More than plaques<\/strong><\/h2>\n

Alzheimer\u2019s afflicts more than 6 million people in the United States alone, including some 76,000 people in Colorado<\/a>, where the cost to the state\u2019s Medicaid program tops $630 million annually. That doesn\u2019t count the costs to private insurers, much less the burden on families which amounts to an estimated $3.7 billion a year in unpaid care.<\/p>\n

Given the immense personal, societal, and financial impacts of Alzheimer\u2019s disease \u2013 and the potentially massive market for an effective Alzheimer\u2019s drug \u2013 the pharmaceutical industry has spent years trying to develop them. Many have focused on clearing out the beta-amyloid protein plaques that collect<\/a> in the brains of Alzheimer\u2019s patients. But those efforts have largely failed<\/a> despite their effectiveness in eliminating the Alzheimer\u2019s-associated plaques.<\/p>\n

Potter says that, while it\u2019s not clear why removing those plaques hasn\u2019t proven pivotal in reversing the course of disease, there are a couple of possible explanations. One is that the damage was already done, so the best-case scenario was to limit the disease\u2019s progression, \u201cand that\u2019s basically what they got.\u201d The other theory is that the drugs have possible side effects that counterbalance the positives of plaque removal, he says.<\/p>\n

Although, Leukine also removes amyloid in mouse models of Alzheimer\u2019s disease, its mechanism of action is more complex than the current approaches of simply using an antibody designed to stick to amyloid to help the body remove it. Leukine may also help the brain heal itself, Potter adds.<\/p>\n

Promising results<\/strong><\/h2>\n

The recently reported CU study was a randomized, placebo-controlled, double-blind (meaning neither those administering the drug nor the patient knew if they were getting the drug or the placebo) phase 2 trial. It involved 40 patients, half of whom got a Leukine injection five days a week for three weeks, half of whom got placebo saline injections instead. The team followed up at 45 days and again at 90 days with neurological, neuropsychological, blood-biomarker and imaging assessments.<\/p>\n

\"CU
CU School of Medicine and UCHealth neurologist Dr. Peter Pressman will lead the follow-on Alzheimer\u2019s clinical trial at the UCHealth Neurology Clinic \u2013 Central Park, which sees more than 2,500 Alzheimer\u2019s patients each year.<\/figcaption><\/figure>\n

Potter and colleagues found that this short-term Leukine treatment boosted numbers of innate and other immune cells and was safe and well-tolerated by participants. Measures of blood biomarkers of Alzheimer\u2019s disease \u2013 brain amyloid, tau-protein tangles, and neurodegeneration \u2013 all improved. Perhaps most strikingly, the team also found that cognition and memory improved by about two points in the 30-point Mini-Mental State Exam.<\/p>\n

\u201cQuite frankly, why Leukine has shown an improvement in at least one measure of memory and cognition is unclear,\u201d Potter said. \u201cIt\u2019s a very complex molecule that has lots of benefits in animal models \u2013 not only with Alzheimer\u2019s disease, but also with stroke, Parkinson\u2019s disease, and aging. It may mean it has many benefits.\u201d<\/p>\n

Long time coming<\/strong><\/h2>\n

The study represents an important milestone in work Potter has been dedicated to since the late 1980s. His efforts to show the link between Alzheimer\u2019s disease and Down syndrome brought him from the University of South Florida to the CU School of Medicine\u2019s Linda Crnic Institute for Down Syndrome in 2012. (The neurons of many patients with Alzheimer\u2019s disease have three copies of chromosome 21 rather than two \u2013 the same trisomy 21 as those born with Down syndrome. All of those with Down syndrome develop Alzheimer\u2019s disease brain pathology, and more than half develop dementia by age 50-60.) The institute as well as the Global Down Syndrome Foundation, among others, have long supported his work.<\/p>\n

Along the way, Tim Boyd, who earned his PhD under Potter\u2019s supervision, led work to test Leukine on mice. Potter suspected that the drug might fight Alzheimer\u2019s disease. Why? Those with rheumatoid arthritis are protected from Alzheimer\u2019s disease, and rheumatoid arthritis patients happen to produce more natural GM-CSF (Leukine\u2019s active ingredient) than usual. Indeed, Boyd found that<\/a> mice engineered for Alzheimer\u2019s that got a three-week course of Leukine cleared 55% of their amyloid plaques \u2013 and that their cognition returned to normal.<\/p>\n

Leukine works by stoking the innate immune system and cooling off inflammation. The combination appears not only to clear plaque, but also rebuild lost and damaged tissue. In mice, Leukine stimulates the development of new neural stem cells and new nerve cell connections to fill the voids the plaque had left behind. Leukine has also been shown to help regrow blood vessels. That combination could help patients who take Leukine avoid the problems of drugs that just clear out plaques leave voids that can induce brain swelling and microhemorrhaging known as ARIA (amyloid related imaging abnormalities).<\/p>\n

The team\u2019s prior Leukine research also extended to humans. They\u00a0studied<\/a>\u00a0the cognition of bone marrow transplant patients who had taken Leukine for the standard three-week course of injections. They found that, six months later, such patients showed improved cognition and function as compared to those treated only with a different immune-system booster. More recently, Potter, Boyd, and others in the CU School of Medicine\u2019s Neurology Department suggested early in the COVID-19 pandemic that Leukine could help repair the lungs of those with severe cases \u2013 an insight that appears to be bearing out<\/a> in practice.<\/p>\n

Follow-on study launching soon<\/strong><\/h2>\n

The recent study\u2019s promising results are leading to a longer-term follow-on trial at UCHealth Neurology Clinic \u2013 Central Park. Neurologist Dr. Peter Pressman<\/a> will lead the clinical trial with Potter. It\u2019s tentatively set for launch in May. Of the 42 participants with Alzheimer\u2019s disease, 28 will receive Leukine injections five days a week for six months and 14 will receive placebo saline injections.<\/p>\n

The study \u2013 also a randomized, placebo-controlled, double-blind phase 2 trial \u2013 has two main goals, Pressman says. First, it will assess the safety of Leukine when taken over a period of months rather than weeks.<\/p>\n

\u201cYou don\u2019t usually need to take sargramostim over this really extended period of time, and especially among people with Alzheimer\u2019s disease,\u201d he said. \u201cWe want to make sure we can give it to people safely.\u201d<\/p>\n

The second goal is to see if the cognitive improvement measured in the most recent study manifests among those who take the drug for 24 weeks. That improvement will be measured through both standard tests and reports from patients and families on how they\u2019re faring in their day-to-day lives, Pressman says.<\/p>\n

\u2018We know so much more\u2019<\/strong><\/h2>\n

If these Leukine injections prove to be safe and to help Alzheimer\u2019s patients, the next step would be a major, phase 3 trial involving multiple medical centers and thousands of patients.<\/p>\n

Pressman says the demand is certainly there: He and colleagues at UCHealth Neurology Clinic \u2013 Central Park see more than 2,500 Alzheimer\u2019s patients a year and have a six-month waiting list. (The clinic is expanding capacity, he says, but it still won\u2019t be able to keep up with a disease that afflicts one in nine people over age 65). With Alzheimer\u2019s drugs such as cholinesterase inhibitors and memantine providing little relief, lifestyle changes related to diet<\/a> and exercise<\/a> are common prescriptions today, he says.<\/p>\n

It\u2019s still early days, and hundreds of experimental Alzheimer\u2019s drugs have failed. Leukine, even if effective, could prove inferior to one or more of the roughly 100 drugs currently in clinical trials for the disease. Potter will let the scientific process play out as he always has, he says.<\/p>\n

\u201cI\u2019m very optimistic, not only for the potential for Leukine, but I\u2019m also optimistic that academic and industry scientists are working together on other approaches,\u201d he said.
\n\u201cWe know so much more about the disease than we did even five years ago.\u201d<\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

Call it Leukine. Call it sargramostim. Call it, if you dare, granulocyte-macrophage colony stimulating factor (GM-CSF). Whatever you call it, the little-prescribed drug approved 30 years ago to boost white blood cell production among bone-marrow transplant patients shows increasing promise as a therapy with the potential to not only stop \u2013 but perhaps even reverse […]<\/p>\n","protected":false},"author":23,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[5],"tags":[4781],"class_list":["post-39364","post","type-post","status-publish","format-standard","hentry","category-innovative-care","tag-research-in-health-care"],"acf":[],"yoast_head":"\nScientists launch follow-on study to understand Leukine's effectiveness in helping Alzheimer's patients - 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