NIA News Briefs
![photo of Bayview building](https://webarchive.library.unt.edu/web/20090507220556im_/http://www.nia.nih.gov/NR/rdonlyres/EC6E26C8-13D1-4481-BFE0-8D5E28753E6C/12093/BayviewBuildingsmaller.jpg) The new Biomedical Research Center |
Senators Tour New Baltimore Research Facility
On June 2, Sens. Barbara Mikulski (D-MD) and Benjamin Cardin (D-MD) visited NIH’s newest research facility, the Biomedical Research Center (BRC) in Baltimore, to support and promote scientific research. Led by then-NIH Director Dr. Elias Zerhouni, with NIA Director Dr. Richard J. Hodes and National Institute on Drug Abuse (NIDA) Director Dr. Nora Volkow, the senators spent the morning discussing the scientific research taking place in the new venue.
The session featured a briefing by Dr. Mark Mattson of NIA on studies in Alzheimer’s and other neurodegenerative diseases, Dr. Elliot Stein of NIDA on imaging of brain changes due to drug abuse, and Dr. Samuel Durso of Johns Hopkins on Hopkins’ “Senior Strategy” program to improve health outcomes for older people.
![](https://webarchive.library.unt.edu/web/20090507220556im_/http://www.nia.nih.gov/NR/rdonlyres/EC6E26C8-13D1-4481-BFE0-8D5E28753E6C/12151/BenCardinsmallerfinal.jpg) ![](https://webarchive.library.unt.edu/web/20090507220556im_/http://www.nia.nih.gov/NR/rdonlyres/EC6E26C8-13D1-4481-BFE0-8D5E28753E6C/12152/BarbaraMikulskismallerfinal.jpg) U.S. Sens. Benjamin Cardin and Barbara Mikulski present remarks during the June 2 opening celebration of the new Biomedical Research Center in Baltimore. |
The approximately 500,000- square-foot, two-tower structure is a leased facility on the Johns Hopkins Bayview campus, where NIA and NIDA have long conducted intramural research in other facilities. The new building allows expansion and updating of key research labs and houses laboratory, vivarium, and administrative activities. Dr. Zerhouni noted that challenges in constructing the structure for state-of-the-art experiments have been met, and the ability of approximately 800 scientists to work in the new facility will be second to none.
The senators’ visit was a celebration of the BRC, and, more broadly, the NIH scientific enterprise. In remarks to scientists, administrators, and media, Sens. Mikulski and Cardin praised the work of NIH researchers and the significance of studies to address the needs of an aging population and the issues of drug abuse.
“We’ve got to do things differently,” Sen. Cardin noted, in meeting these challenges in the future, and the work being done at BRC will play a critical role.
Sen. Mikulski, who was active in the development of the site, praised the facility. However, she stated, “It’s not about the building. Our job is to save lives,” highlighting NIH’s importance in helping Americans to live longer, better, and healthier lives. “We’re going to win Nobel Prizes here,” she said.
International AD Meeting Highlights Research Advances
The International Conference on Alzheimer’s Disease (ICAD), sponsored by the Alzheimer’s Association in Chicago in July 2008, attracted more than 5,400 researchers, physicians, and advocates seeking a better understanding of the complex neurodegenerative disorder. Through some 2,000 plenary, symposium, oral, and poster presentations, ICAD offered a forum to explore and advance the science behind Alzheimer’s disease (AD) and other types of dementia.
NIA, the world’s leading funder of AD research, supported much of the work reported at the conference, in areas ranging from drug and nonpharmacological intervention trials and neuroimaging to genetics, basic cellular and molecular research, and social and behavioral issues. Private-sector efforts were presented as well, with several studies built on a foundation laid by federally supported work.
“ICAD presentations included an array of new drugs in the pipeline that look promising, as well as drugs that have been used for other diseases and disorders. They also included reports on advances in biomarkers and new approaches to the clinical treatment of Alzheimer’s disease,” said Dr. Marcelle Morrison-Bogorad, director of NIA’s Division of Neuroscience.
“The meeting also highlighted the challenges facing researchers, from fully understanding Alzheimer’s basic pathology to designing and conducting clinical trials when physical changes in the brain take place decades before symptoms appear,” she noted.
Drug investigators continue to target beta-amyloid protein (a protein found in clumps or plaques in the brains of people with AD) in their search for therapies to slow or stop the progression of AD.
In a pilot clinical trial, intravenous immunoglobulin (IVIg), used for 25 years to treat autoimmune diseases, was found to improve the cognitive health of patients with mild to moderate AD. A phase III clinical trial is testing whether IVIg can modify the course of mild AD.
The following industry-sponsored trials were reported at ICAD:
PBT2, a metal-protein-attenuating compound being developed by Prana Biotechnology Ltd., in Parkville, Australia, reduced the toxic form of beta-amyloid by preventing its interaction with copper and zinc. Results of a phase IIa clinical trial in people with early-stage AD were similar to the pattern of improvement observed in animal models. PBT2 improved executive function, an important aspect of cognitive performance, in these patients.
New potential drug treatments are aiming at diverse targets, such as tau protein aggregates, which form tangles in the brains of people with AD; the healthy functioning of mitochondria; and the loss of synapses in AD patients.
Dimebon, an antihistamine, stabilized and improved cognitive function in patients with mild to moderate AD, in a 6-month, open-label trial in Russia. A phase III clinical trial is now recruiting participants for testing the drug, which is believed to improve mitochondrial function.
Rember, a novel form of the dye methylthioninium chloride, was found to reduce AD progression for mild- to moderate-AD patients in a phase II trial. The developer, TauRx Therapeutics of Singapore, says that the drug attacks tau, thereby reducing neurofibrillary tangles. A phase III trial awaits Food and Drug Administration approval.
The peptide AL-108, given by nasal spray, improved some aspects of memory among patients with amnestic MCI, in a phase II clinical trial. The compound is designed to combat tau tangles and will now be tested on AD patients. Preclinical testing of this compound was funded by NIA.
Souvenaid, a once-a-day, multinutrient drink containing a synergistic combination of active nutrients, was reported to improve memory in patients with early-stage AD. Its development, by Danone Research Centre for Specialized Nutrition, in Frampton, United Kingdom, is based on the idea that nutrients increase synapse formation and reduce the production of beta-amyloid. The design for the nutrient-filled drink is based on NIA-funded work conducted by the Massachusetts Institute of Technology.
Some researchers are focused on methods to identify biomarkers—from simple blood tests to imaging techniques—that may improve diagnosis of AD in its earliest stages and improve treatment.
A low level of beta-amyloid-42, a sticky variety of amyloid protein, in cerebrospinal fluid correlates with high levels of amyloid in the brain, even in nondemented individuals. These findings eventually may be used to identify preclinical AD at its earliest stages and to improve treatment.
A new blood test shows that CD-69, a protein involved in white blood cell growth, enabled researchers to differentiate between AD patients and Parkinson’s patients with dementia, and between AD patients and those without the disease. A larger study is now underway.
Physical inactivity and mental inactivity are associated with cognitive decline. Now researchers are using imaging and other methods to demonstrate that lifestyle changes and exercise can improve the quality of life for AD patients.
Researchers using MRI and other neuroimaging techniques found a direct link between the size of the hippocampus of the brain and cardiovascular fitness in early-AD patients. The more fit the AD patient, the larger the hippocampus.
Metabolic syndrome, a group of heart disease risk factors that includes abdominal obesity, elevated blood pressure, and low HDL cholesterol, may play a role in cognitive decline with age. Older people with the syndrome had an almost 35 percent lower level of cognitive performance than did similarly aged people free of the disorder.
For more information on ICAD, go to www.alz.org/icad.
Clinical Research Study Investigator's Toolbox Available Online
The NIA Clinical Research Toolbox is a Web-based information repository for investigators and staff involved in clinical research. The Toolbox contains templates, sample forms, guidelines, regulations, and information materials to assist investigators in the development and conduct of high-quality clinical research studies.
Among the items in the Toolbox are:
A clinical intervention study protocol template, which outlines a clinical trial protocol and provides guidance on important content to include in each section.
A manual of procedures to facilitate consistency in protocol implementation and data collection across study participants and sites.
Recruitment and retention tips describing approaches to recruitment and retention of older individuals from diverse ethnic and racial groups in clinical research studies.
Adverse events and serious adverse events guidelines, describing requirements and processes for reporting adverse events and unanticipated problems to the study's safety monitoring bodies.
Data and safety monitoring plan guidelines, including extensive information, templates, and checklists for overseeing the data and safety monitoring for clinical research and ensuring participant safety.
Informed consent templates and checklists to provide individuals with sufficient information for making informed decisions about participation in a clinical research study.
Data management tips to help ensure adequate data management processes and procedures in a clinical trial.
Study forms that can be customized for almost any clinical research study and include the commonly used demographics, study completion and other general forms.
Glossary of clinical research terms to define terms related to NIH funding of clinical research.
The Toolbox is available at http://www.nia.nih.gov/ResearchInformation/CTtoolbox/.