Alzheimer’s disease drug developed at Roskamp Institute approved for key clinical trial funding in Europe

Nilvadipine, an Alzheimer’s drug developed at the Roskamp Institute in Sarasota announced earlier this year was selected for funding or a large-scale European clinical trial. An international research consortium led by Trinity College Dublin (Ireland) announced more than 500 patients will participate in the multicenter Phase III clinical trial designed to study the effectiveness of Nilvadipine.

Michael Mullan, M.D., Ph.D., Roskamp Institute director who, with associate director Fiona Crawford, Ph.D and lead scientist Daniel Paris, Ph.D., led the research team that developed the drug. Mullan said, “We need many more medicines to move forward into advanced clinical trials in the fight against Alzheimer’s Disease and we are pleased the Roskamp institute has played such a major role in the development of this drug.” Before a drug can move into clinical practice, Phase III is usually the last step in the regulatory process.

The clinical trials will take place in Europe, where Brian Lawlor, M.D., Connolly Norman Professor of Old Age Psychiatry at Trinity College Dublin, Ireland, will be principal investigator and coordinator. The study will be funded by the European Commission Seventh Framework Programme and more than 20 European clinical sites will participate. Nilvadipine is already approved for the use in mild cases of hypertension (high blood pressure) and Mullan says, “The process can move more quickly in Europe, and the study findings may help accelerate the process with the U.S food and Drug Administration (FDA).

Mullan and Crawford have been studying Alzheimer’s disease for more than 20 years, moving from the UK to Florida in 1991 and to Sarasota in 2003 to establish the Roskamp Institute. “Some of our recent studies have involved Sarasota area residents, who have contributed to our understanding of Alzheimer’s disease and helped move the development process forward,” said Crawford. Now, the Roskamp Institute will provide research support for the Phase III clinical trial, such as assessing genetic and other markers for Alzheimer’s disease in study participants.

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Roskamp institute studies may lead to better diagnosis

Researchers at the Roskamp Institute have new studies that could lead to better diagnosis and eventual treatment for U.S. military personnel as well as other patients with TBI, commonly known as traumatic brain injuries.

Fiona Crawford, Ph.D., associate director of the Institute, a leading research facility for Alzheimer’s disease and other neurological disorders says, “We have found that there are changes in blood proteins that occur after a head injury, and that these are dependent on the severity of the injury, the time since the injury and genetic factors influencing outcomes after head injury.” Crawford’s research indicates that TBI can affect cellular mechanisms in the brain long after the original trauma, and that blood biomarkers reflect these ongoing processes. She also stated, “Translating these finding from the laboratory to human patients may help clinicians determine the extent of the brain injury, how long ago the injury occurred and the patient’s prognosis for a favorable or a poor outcome.”

Traumatic brain injury has multiple consequences at the cellular level and so molecular changes can persist for weeks and months after the initial brain swelling and other immediate issues have resolved. Crawford says, “Identifying blood biomarkers of mild TBI would improve medical management by enabling us to identify patients who need treatment or intervention, even if they do not have obvious signs of a brain injury.” The U.S. Department of Defense, and the Veterans Administration supports all of Crawford’s work because it could lead to better diagnosis of military personnel with mild brain injuries and better long-term care of our veterans.

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Research Highlights The Direct Causes Related To The Disease

Alzheimer’s disease affects patients over 65 years of age and is classified as a type of dementia. However, the less prevalent early-onset Alzheimer’s can also occur earlier than 65 years of age as shown by several researches. As per the 2006 statistics, there were 26.6 million patients of Alzheimer’s and it is estimated that the disease will affect 1 in 85 people globally by 2050. Presently, there are no cures available for the disease and it is estimated to get worse with age gradually leading to death. Alzheimer’s is calculated to affect a person’s memory, affects the ability to learn and also types of behavioral changes.
Dr. Michael Mullan is a highly accredited biomedical professional and has contributed vastly to the field of research on neurodegenerative disorders conditions such as Alzheimer’s disease. He is chaired as the Director at Roskamp Institute. He is based in Sarasota, Florida, and is exceptionally qualified in finding cures for neuropsychiatric and neurodegenerative disorders and addictions. The Roskamp Institute utilizes superior scientific approaches along with Dr. Mullan to understand the root causes and potential therapies of disorders such as Alzheimer’s disease. Aside researching on Alzheimer’s, the institute has successfully studied other illnesses and disorders such as Gulf War Illness, Brain Research, etc.
With Dr. Mullan’s Alzheimer research, science has come to a better understanding of the disease and of developing its prospective cures. Dr. Mullan’s Alzheimer research proves that one of the direct causes related to the disease is the excess accumulation of beta-amyloid which is a type of protein in the brain. It is noticed that the protein is produced in every human, but its excess accumulation can result in Alzheimer’s. Along with the team, Dr. Mullan’s Alzheimer research has tested many medications and therapeutic treatments to help slowing down the accumulation of beta-amyloid and associated inflammation.
About Dr Michael Mullan
Dr Michael Mullan has been working in the biomedical field for many years. He is a leading researcher with special expertise in assessment of the earliest cognitive symptoms and stages of Alzheimer’s disease. Mullan’s Alzheimer research works are also published in various articles which help students and researchers for making new discoveries. Find out more about his Alzheimer research works, by browsing through www.rfdn.org or www.mullanalzheimer.com or www.mullanalzheimer.info.

Dr. Mullan’s Alzheimer Research Involved Studying Brain Proteins

The Roskamp Institute has surfaced as a leading and reputable non-for-profit biomedical research organization. It has successfully experimented to find cures for several neurodegenerative disorders and conditions like Alzheimer’s disease. Through the clinical trials division and outpatient clinic, at the institute, thousands of Alzheimer’s patients get superior services and therapeutic treatments. Dr. Michael Mullan is the Director of Roskamp Institute. Dr. Mullan is an experienced and a competent individual. His research efforts led to the identification of Swiss Mutation.
Along with Dr. Mullan, the institute has helped in contributing to provide insights on the treatments of neuropsychiatric disorders such as Alzheimer, traumatic brain injury, substance abuse, etc. through unparalleled research. Under the supervision and guidance of Dr. Michael Mullan, several causes and cures related to Alzheimer’s disease have been found. Dr. Mullan’s Alzheimer research identified various types of genetic variations which may be the cause of predispose humans to this disease. His research and study identified that the central reason to the disease process is a small protein known as ß (beta)-amyloid. The excess and abnormal accumulation of ß-amyloid in the brain results in Alzheimer’s disease. With Dr. Mullan’s Alzheimer research, cutting edge cures, medications, and therapeutic treatments are tested and developed to help slow down the process of ß-amyloid’s toxic accumulation.
As per the research on Dr Mullan’s Alzheimer, Aβ peptide is responsible for preventing blood vessel growth and inhibiting tumor growth. He studied several particular sequences within the Alzheimer’s Aβ peptide to identify if Aβ can have the same effect with short derivatives as well. The research proved that the peptide has potential therapeutic relevance to prevent the growth of tumor. The research involved conducting clinical trials which are specifically conducted to developing superior treatments for neurodegenerative diseases. In order to understand the diseases and finding its causes and prevention, Dr. Mullan’s Alzheimer research work has contributed extraordinarily in the field. Furthermore, with his constant efforts and guidance, the Roskamp Institute was also able to carry out research in neuropsychiatric disorders such as Traumatic Brain Research, Gulf War Illness, and Alzheimer’s. Find out more about his Alzheimer research works, by browsing through www.rfdn.org or www.mullanalzheimer.com or www.mullanalzheimer.info.

Roskamp Institute researchers show that some antibodies but, not others may be helpful in removing the Alzheimer amyloid from the brain of Alzheimer’s sufferers.

The Roskamp Institute researchers show that some antibodies but, not others may be helpful in removing the Alzheimer amyloid from the brain of Alzheimer’s sufferers. Drs. Corbin Bachmeier, Daniel Paris, and Michael Mullan at the Roskamp Institute have been working on ways to improve the removal of the Alzheimer amyloid peptide from the brain. Using antibodies to amyloid and in an vitro model of the blood brain barrier, the Roskamp Institute researchers have shown that certain antibodies can enhance the clearance of amyloid from the brain side to the blood side. However, they also showed that other antibodies were not able to do this. The researchers explained that the difference in ability to remove amyloid has to do with a receptor called RAGE. The RAGE receptor is responsible for taking amyloid from the blood into the brain. The researchers suggested that the antibodies which bind amyloid but block its uptake by RAGE keep amyloid in the blood and thus, allow its removal from the body by the liver. As a consequence of removal of amyloid from the blood, more amyloid flows from the brain into the blood. However, antibodies which bind amyloid but still allow it to be taken up by the RAGE receptor do not stop it from being taken back from the blood into the brain. Thus, antibodies which bind amyloid and block its uptake by the RAGE receptor are thought to be most preferable. Antibodies to the Alzhemier amyloid peptide are being developed by a number of pharmaceutical companies to encourage the removal of amyloid from the Alzheimer brain.

The Roskamp Institute, under the leadership of Drs. Michael Mullan and Fiona Crawford, is dedicated to finding new treatments and cures for Alzheimer’s disease and related disorders.

Microcirculation. 2011 Jul;18(5):373-9. Epitope-dependent effects of Beta-amyloid antibodies on Beta-amyloid clearance in an in vitro model of the blood-brain barrier. Bachmeier CJ, Beaulieu-Abdelahad D, Mullan M, Paris D.

 

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michael mullan, alzheimer, mullan alzheimer, mullan roskamp, roskamp institute, amyloid

Mullan Alzheimer Research Institute Roskamp Institute aids high school students in genetic research

Dr. Mullan Alzheimer Research Institute helps high school student to be involved in research………

Roskamp Institute aids high school students in genetic research

Roskamp aids high school students in genetic research

By JENNIFER RICH – jrich@bradenton.com

They look like scientists in their white coats, working in the Roskamp Institute’s lab using microscopes and high-tech research equipment.

But they’re high school students doing genetic research just like the adults working alongside.

It’s probably the best hands-on learning experience in the world for teens who hope to major in fields like chemical engineering and organic chemistry when they go to college, says James Humphrey, chief operating officer at Roskamp.

Read more: http://www.bradenton.com/2011/11/14/3649043/bridging-the-gap.html#ixzz1dgyk7Niz

 

 

The Roskamp Institute investigates the role of anatabine in lowering Alzheimer’s Abeta levels.

The Roskamp Institute has had a long-term interest in finding new treatments for Alzheimer’s disease. Central to the goal of the institute is finding new ways to lower the accumulation of Alzheimers Abeta peptide in the brain. Drs. Michael Mullan and Daniel Paris and colleague investigated the role of an extract of tobacco, known as anatabine in the production and accumulation of the Alzheimer Abeta peptide. Paris and Mullan and colleagues showed that anatabine did lower the production of the Alzheimers Abeta peptide in cell culture — in cells genetically engineered to produce the Alzheimers Abeta peptide. In addition, they showed that al  in an animal model of Alzheimer’s disease which overproduces the Alzheimers  Abeta peptide, anatabine was able to lower the accumulation of amyloid in the brain. The paper cited below that resulted from this work was published in the European Journal of Pharmacology in September of 2011. Collectively, the work suggests that anatabine, a naturally occurring tobacco product and one which occurs in other plants and is in the human food chain, may have potential beneficial effects in Alzheimer’s disease.

The Roskamp Institute, headed by Drs. Michael Mullan and Fiona Crawford is dedicated to finding new treatments for Alzheimer’s disease. Drs. Mullan and Crawford were among those who first showed that certain early onset forms of Alzheimer’s are caused by accumulation of Alzheimers Abeta peptide. These findings contributed to the worldwide use of models of Alzheimer’s disease which contain human mutant amyloid precursor protein.

Eur J Pharmacol. 2011 Sep 19. [Epub ahead of print] Anatabine lowers Alzheimer’s Aβ production in vitro and in vivo.
Paris D, Beaulieu-Abdelahad D, Bachmeier C, Reed J, Ait-Ghezala G, Bishop A, Chao J, Mathura V, Crawford F, Mullan M.

 

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Dr. Mullan Alzheimer Presentation at Pines of Sarasota

Alzheimer’s disease: Amyloid Plaque (Excerpt from “On The Forefront”)  Video shows Dr. Michael Mullan (Dr. Mullan Alzheimer Researcher at the Roskamp Institute) presenting information to audience about Alzheimer’s Disease.Beta Amyloid Presentation By Dr. Michael Mullan (Mullan Alzheimer Researcher)

Roskamp Institute Celebrated Veterans Day with a seminar by Alzheimer Researcher Dr. Michael Mullan

Dr. Fiona Crawford presentedVideo of Alzheimer Research Institute Headed By Dr. Mullan Presentation on Traumatic Brain Injury a synopsis
of her recent study of traumatic brain injury
(TBI). Her recently published findings
show how TBI can affect the brain’s
inflammatory mechanisms, changes in
protein levels and cellular pathways, long
after the original trauma. Dr. Crawford’s
work has been followed closely by the
U.S. Department of Defense, because it
could lead to better diagnosis of military
personnel with mild brain injuries.

 

 

 

 

Dr. Fiona Crawford — Discussion of research programs underway at
Roskamp Institute with Veterans and current combat military personnel
Dr. Michael Mullan – Research and treatment being done in
Alzheimer’s Disease, dementia, depression, and related disorders
Dr. Andrew Keegan – Associate Director, Roskamp Institute Clinic
Memory screens, clinical trials, neurological services
Tours available of Roskamp Institute Research Laboratory
Veteran’s Administration representatives will be on site
Information tables and Roskamp Institute personnel to discuss clinic services,
memory screens, clinical drug trials and volunteer opportunities.

Alzheimer Expert Dr. Mullan’s comments on CD40L induces Abeta production via signaling by the granulocyte macrophage colony stimulating factor (GM-CSF)

Abeta Amyloid Mullan Alzheimer

Abeta Amyloid Mullan AlzheimerAlzheimer’s disease (AD) is the most common type of dementia in the elderly. AD is mainly characterized by the accumulation of a small molecule (known as amyloid beta (Ab)) in the brain. Many researchers have shown that the molecule CD40L is elevated in AD patients. Roskamp Institute Alzheimer’s research group headed by Dr. Michael Mullan also have recently shown that CD40L stimulation increases Ab levels in cellular models of the disease. Furthermore, Mullan’s Alzheimer group has shown that CD40L stimulation of cells that are important for the defense of the nervous system induces increases in pro-inflammatory molecules known as cytokines. The granulocyte macrophage colony stimulating factor (GM-CSF) is one of these cytokines involved in inflammation responses in the brain. Numerous studies have correlated AD with increases in pro-inflammatory cytokines. In the cytokine paper, we have shown that CD40L stimulation increases the levels of both GM-CSF and Ab in AD cell models. We have shown that treatment of these cells with GM-CSF causes a time dependent significant increase in Ab levels. We demonstrate that blocking GM-CSF reduces CD40L-induced Ab production in a dose dependent manner. In addition, we show that inhibiting GM-CSF signaling by silencing the GM-CSF receptor gene significantly reduces Ab levels to below basal levels in non-CD40L-stimulated by blocking the trafficking of Ab’s mother protein, the amyloid precursor protein. Our results that are now published in the Journal cytokine (Volmar et al., in press) suggest that GM-CSF operates downstream of CD40/CD40L interaction and that GM-CSF modulates Ab production.

 

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Alzheimer Researcher Dr. Michael Mullans Note on Potent anti-angiogenic motifs within the Alzheimer beta-amyloid peptide.

A study entitled “Potent anti-angiogenic motifs within the Alzheimer’s β-amyloid peptide” was published in the January 2008 issue of the journal Amyloid. Building on previous work by Dr. Michael Mullan showing that the Alzheimer’s Aβ peptide is able to prevent blood vessel growth and inhibit tumor growth, Dr. Michael Mullan and other Roskamp Institute scientists researched particular sequences within the Alzheimer’s Aβ peptide in order to identify whether short derivatives of Aβ are able to have the same effect. Inhibition of blood vessel growth is an attractive approach for preventing tumorigenesis since tumors need an adequate blood supply to grow beyond a certain size. Using different fragments of the Aβ peptide, we have identified, for the first time, a critical 8 amino acid sequence within the Aβ peptide, HHQKLVFF, which is able to block blood vessel growth. This short peptide has potential therapeutic relevance for the prevention of tumor growth.

 

For more details read the journal article at:

Patel NS, Quadros A, Brem S, Wotoczek-Obadia M, Mathura VS, Laporte V, Mullan M, Paris D. Amyloid. 2008 Mar;15(1):5-19.

 

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Effect of NSAIDS on cognitive ability of Alzheimer’s Patient — Comment by Alzheimer Researcher Mullan

Medications that reduce inflammation known as non-steroidal anti-inflammatory drugs (NSAIDS) do not improve thinking abilities in normal seniors.  These findings from the Alzheimer’s Disease Anti-Inflammatory Prevention Trial (ADAPT) were published this month in Archives of Neurology. The Roskamp Institute Memory Clinic in Tampa was one of a handful of centers across the United States that took part in this study that was supported by the Federal Government. The Tampa clinic enrolled over 400 seniors (age 70 or older) with at least one relative with a dementia. The group was studied for 5 years, undergoing memory testing every year. Two-thirds of the participants received NSAIDS, either Naproxen, or Celecoxib, and one- third, a sugar pill. The study reports that one of the treatments (Naproxen) may contribute to worsening memory or other mental abilities. However further study is needed to determine if these finding persists over time, or if seniors who performed worse on memory testing were experiencing the early signs of a dementia.Drs. Cheryl Luis and Timothy Crowell, specialists in Neuropsychology, supervised the day-to-day aspects of the study in Tampa. Dr. Michael Mullan, director of the Roskamp Institute and principal investigator. Also please read other interesting articles at the Dr. Mullan’s Alzheimer Research notes website: http://www.mullanalzheimer.com

Dr. Mullan’s Alzheimer Research Notes on NSAIDS and their effect on Alzheimers disease

Non-steroidal anti-inflammatory (NSAIDS) drugs such as Naproxen and Celecoxib do not improve cognition in at-risk older adults. These findings from the Alzheimer’s Disease Anti-Inflammatory Prevention Trial (ADAPT) were published this month in Archives of Neurology. The Roskamp Institute Memory Clinic in Tampa was one of a handful of centers across the United States that took part in this primary prevention trial funded by the National Institute of Aging. The Tampa site enrolled over 400 subjects, age 70 or older with a reported family history of Alzheimer’s-like dementia. During the 5-year study period, participants underwent annual cognitive testing and were randomly assigned to one of two treatments (Naproxen 220 mg twice daily, Celecoxib 220 mg twice daily) or a placebo. Although treatment was suspended in 2004, following a report of increased cardiovascular risk in another prevention trial, subjects continued annual follow-up. Results examining the cognitive data collected up to 6 months after treatment was discontinued suggest that Naproxen may in fact have a small deleterious effect on cognition. However further study is needed to determine if this effect is mitigated or exaggerated over time, or if results were influenced by subjects who may have been in the early stage of a dementia. Drs. Cheryl Luis and Timothy Crowell, specialists in Neuropsychology, supervised the day-to-day aspects of the study in Tampa. Dr. Michael Mullan, director of the Roskamp Institute and principal investigator for the Tampa site served on the writing committee of the manuscript. Go to http://www.ncbi.nlm.nih.gov/pubmed/18474729 for more information. Also please read other interesting articles at the Dr. Mullan’s Alzheimer Research notes website: http://www.mullanalzheimer.com