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Parkinson's Disease Research Web: Events in FY 2001

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All FY2001 Events related to Parkinson's disease research have been categorized according to the following Sub-topics. Abstracts of each event have been included.

Program Announcements

Plasticity of Human Stem Cells in the Nervous System (PA-02-025)

The National Institute of Neurological Disorders and Stroke (NINDS), the National Institute on Aging (NIA), the National Institute of Mental Health (NIMH) and the National Heart, Lung, and Blood Institute (NHLBI) invite applications for studies on the plasticity and behavior of human stem cells, and regulation of their replication, differentiation and function in the nervous system. Projects that address comparisons between different classes of human stem cells, and between human and non-human stem cells would also be directly relevant to this PA.

Development of PET and SPECT Ligands for Brain Imaging (SBIR Awards) (PA-02-028)

The use of radiotracers for imaging molecular events in preclinical and clinical studies is essential for understanding the biological basis of normal brain function and the pathophysiology of brain disorders. Nevertheless, there is a paucity of versatile agonist and antagonist positron emission tomography (PET) and single photon emission computed tomography (SPECT) radiotracers for molecular targets that are implicated in brain disorders. The intent of this Program Announcement (PA) is to invite applications for the commercial development of novel radioligands for PET and SPECT imaging in human brain, and to incorporate pilot or clinical feasibility evaluation in pre-clinical studies, model development, or clinical studies.

Probes for Microimaging the Nervous System (SBIR Awards) (PA-02-029)

The National Institute of Mental Health (NIMH), National Institute on Deafness and Other Communication Disorders (NIDCD), National Institute on Neurological Disorders and Stroke (NINDS), National Institute on Aging (NIA), and National Institute of Biomedical Imaging and Bioengineering (NIBIB) invite grant applications for Small Business Innovation Research (SBIR) projects on research and development of probes useful in imaging the structure and function of the brain and other parts of the nervous system, with award duration and amounts greater than those routinely allowed under the SBIR program. Encouraged are applications from teams of investigators from commercial, academic and other sectors of the research community. Non- commercial partners, including those at colleges and universities, may play important roles in SBIR-supported research, and may receive substantial support for their efforts.

The Biology of Non-Human Stem Cells in the Environment of the Nervous System (PA-01-078)

The National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Mental Health (NIMH), the National Institute on Deafness and Other Communication Disorders (NIDCD), the National Institute on Aging (NIA) and the National Institute of Child Health and Human Development (NICHD) are committed to the discovery of effective treatments for neurological disorders, and invite applications for studies on the biology of non-human stem cells and regulation of their replication, development and function in the nervous system. The tremendous plasticity exhibited by stem and progenitor cells raises the possibility that they can be used to replace components and restore function to parts of the brain that have been compromised by congenital disorders, developmental malfunction, injury or disease. There is, however, little understanding of the behavior and regulation of these cells in the environment of the healthy brain, or in the nervous system altered by such conditions as stroke, trauma, spinal cord injury, sensory loss, Muscular Dystrophy, Amyotrophic Lateral Sclerosis, Parkinson's Disease, Huntington's Disease, Alzheimer's Disease, Multiple Sclerosis or mental illness. There are few studies on the long-term fates of transplanted cells within the nervous system or at other sites within the host. An understanding of environmental cues, age-dependent processes and genetic factors that govern the activities of these cells is crucial in order to develop safe and effective cell-replacement treatments. This Program Announcement encourages applications for support of ground-breaking research on non-human stem cells that address these issues.

NINDS Clinical Trial Planning Grant (PAR-01-118)

The NINDS seeks to fund high quality clinical trials to evaluate treatments for neurological disorders. The NINDS Clinical Trial Planning Grant allows for early peer review of the rationale and design for clinical trials of treatments for neurological disorders and provides support for the development of a detailed clinical trial research plan, including a complete manual of operations and procedures.

Pilot Studies for Clinical Trials in Neurological Disorders (PAR-01-119)

The NINDS is committed to identifying effective treatments for neurological disorders by supporting well-executed clinical trials. Before proceeding to a full-scale clinical trial, pilot clinical studies are often required. The NINDS announces its interest in supporting pilot studies required to obtain necessary information to clearly establish the clinical basis for proceeding to a full- scale trial. The purpose of PILOT STUDIES FOR CLINICAL TRIALS IN NEUROLOGICAL DISORDERS grant (for brevity referred to as NINDS Pilot Studies grant) is to obtain preliminary data and conduct studies to support the rationale for a subsequent full-scale clinical trial of an intervention to treat or prevent neurological disease.

The Biology of Non-Human Stem Cells in the Environment of the Nervous System (PA-01-078)

The National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Mental Health (NIMH), the National Institute on Deafness and Other Communication Disorders (NIDCD), the National Institute on Aging (NIA) and the National Institute of Child Health and Human Development (NICHD) are committed to the discovery of effective treatments for neurological disorders, and invite applications for studies on the biology of non-human stem cells and regulation of their replication, development and function in the nervous system. The tremendous plasticity exhibited by stem and progenitor cells raises the possibility that they can be used to replace components and restore function to parts of the brain that have been compromised by congenital disorders, developmental malfunction, injury or disease. There is, however, little understanding of the behavior and regulation of these cells in the environment of the healthy brain, or in the nervous system altered by such conditions as stroke, trauma, spinal cord injury, sensory loss, Muscular Dystrophy, Amyotrophic Lateral Sclerosis, Parkinson's Disease, Huntington's Disease, Alzheimer's Disease, Multiple Sclerosis or mental illness. There are few studies on the long-term fates of transplanted cells within the nervous system or at other sites within the host. An understanding of environmental cues, age-dependent processes and genetic factors that govern the activities of these cells is crucial in order to develop safe and effective cell-replacement treatments. This Program Announcement encourages applications for support of ground-breaking research on non-human stem cells that address these issues.

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Requests for Applications (RFA)

Parkinson's Disease Neuroprotection Clinical Trial: Clinical Centers (RFA-NS-02-010)

The Neurodegeneration and Clinical Trial Groups of the National Institute of Neurological Disorders and Stroke (NINDS) request applications for clinical centers to collaborate in the performance of a large, double-blind randomized trial of two or more potential neuroprotective agents in patients early in the course of Parkinson's disease. Applications for coordinating and statistical centers were requested in a separate solicitation (RFA-NS-01-012). The trial was called for in the NIH Parkinson Research Agenda. The neuroprotectants to be tested in the trial have not yet been chosen and will be selected by an NINDS-appointed Oversight Committee from among those proposed by the applicants who respond to this Request for Applications (RFA) as well as from those suggested by others, including NINDS grantees, pharmaceutical companies, patients, and patient advocates.

Gene Therapy for Neurological Disorders (RFA-NS-02-007)

The goal of this Request for Applications (RFA) is to accelerate the translation of gene transfer methodologies into the clinic. Gene therapy holds tremendous promise for the treatment of neurological disorders. Despite recent advances in this area however, specific scientific, technological, and safety goals must be achieved before gene transfer becomes a viable therapeutic alternative. Current needs include more effective methods for controlling the expression of therapeutic transgenes in the brain, better strategies for vector delivery and monitoring transgene expression, more studies addressing the toxicity of specific vector/transgene combinations, and greater knowledge of the long term effects of expressing specific transgenes in the nervous system. This RFA is intended to encourage research projects that address these or related translational issues in the context of specific neurological disorders.

Technology Development for Safe and Effective Deep Brain Stimulation (RFA-NS-02-004)

Deep brain stimulation (DBS) in the thalamus for the treatment of tremor was approved by the FDA in 1997 following the pioneering work of Benabid and colleagues in France. Subsequently it has been found that stimulation in the subthalamic nucleus (STN) or globus pallidus (GPi) can relieve multiple symptoms of Parkinson's disease (PD). DBS has been successful in restoring significant mobility to a large number of patients with advanced PD. During the past year, GPi and STN stimulation underwent review at the FDA for potential use to decrease symptoms of dyskinesia, tremor, postural instability, and/or bradykinesia in individuals with advanced PD. Over two thousand patients have been implanted with DBS systems and the number is growing rapidly. Using the current guidelines, estimations are that as many as 15,000 individuals per year will be candidates for this procedure. This number could increase as the population ages and/or if the indications are expanded to include PD patients with less advanced symptoms. Despite the success of this therapy in some patients, there is significant room for improvement. Complications such as breakage of the electrode lead wires or movement of the stimulating electrode occur. Untoward effects arising from electrical stimulation of neural tissue other than the target tissue can limit stimulation and limit the beneficial effects in some cases. The optimal methods for positioning the electrode and the optimal number and size of the stimulating electrodes has not been determined. In addition, placement of these electrodes carries a small risk of significant complications such as intracranial hemorrhage or infection with potential persistent neurological disability including hemiplegia or cognitive dysfunction. One other limitation to further study of DBS is the lack of suitable stimulation and electrical recording systems that would permit study of DBS in appropriate animal models. Improvement in this treatment modality should be possible through research and development to advance techniques for delivering electrical stimulation to STN, GPi and other brain structures. This announcement will support research to position electrodes in the appropriate target areas, to devise ways to make electrode placement more stable, to increase reliability of electrodes and electrode lead wires, to develop electrodes and systems capable of recording as well as stimulating, to develop electrodes capable of more selective stimulation, to develop better stimulators, and to improve the safety of implanted systems.

Cognitive Neuroimaging: Understanding the Link Between Neuronal Activity and Functional Imaging Signals (RFA-NS-02-009)

Functional brain imaging techniques that take advantage of the changes in hemodynamic responses of the brain (positron emission tomography, functional magnetic resonance imaging, and infrared imaging) have emerged as promising new avenues for studying the neural basis of many different cognitive activities. The National Institute of Neurological Disorders and Stroke (NINDS),the National Institute of Mental Health (NIMH), the National Institute on Aging (NIA), the National Institute on Deafness and Other Communication Disorders (NIDCD), and the National Institute on Drug Abuse (NIDA) invite research grant applications that offer the promise of exceptional technical and conceptual advances in our understanding of the nature of the signal being recorded in hemodynamic brain imaging techniques. We currently have a fundamental gap in our knowledge, because we do not truly understand the linkage between the hemodynamic response that is being recorded in imaging techniques and the supporting cellular and molecular mechanisms. Furthermore, the time course of the hemodynamic response, which evolves over 10 to 15 seconds, has been problematic in the ability of these functional imaging techniques to be applied to issues involving temporal sequencing of various cognitive events. Of particular interest for this RFA would be approaches involving functional imaging and neurophysiological (e.g., single and multi- unit recording) studies conducted entirely in non-human primates intended to address the issue of the neural mechanisms underlying functional activation determined using fMRI or PET techniques. Also of interest are proposals that take advantage of improved understanding of the link between hemodynamic and neural events to increase the ability of functional imaging methods to accurately assess the temporal sequencing of cognitive activation that cannot be answered in humans with current technology. Thus, this RFA seeks proposals that will increase the utility of functional imaging techniques by a) providing greater understanding of the link to underlying neural activity and b) improving the ability of these techniques to address questions with a significant temporal component. In addition to understanding the fundamental physiological processes underlying the signals used in functional brain imaging, it is also critical to recognize that coupling between neuronal activity and blood flow is subject to modulation. Among the largest sources of such modulation are the direct effects of drugs and endogenous neurotransmitters, especially catecholamine, on cerebrovascular function. Such effects can constitute a major confound in studies in which pharmacological agents are administered and studies of populations who routinely take drugs, either for recreational or therapeutic reasons. Examples include cocaine's effects on heart rate and vasoconstriction, dopaminergic D1 receptor modulation of cerebral vasculature, and opioid effects on respiration. Applications are encouraged that propose to study not only the magnitude and extent of drug and endogenous transmitter modulation of the hemodynamic functional imaging signal, but also development of methods and procedures for improving interpretation of functional imaging data when such confounding effects are present.

Parkinson Disease Neuroprotection Clinical Trial: Coordinating and Statistical Centers (RFA-NS-01-012)

The Neurodegeneration and Clinical Trial Groups of the National Institute of Neurological Disorders and Stroke (NINDS) request applications for centers to collaborate in the performance of a large, double-blind randomized trial of two or more potential neuroprotective agents in patients early in the course of Parkinson's disease. Two types of applications are requested: for (1) a Coordinating Center, and (2) a Statistical Center. Applications for multiple Clinical Centers will be sought in a separate solicitation. The trial was called for in the NIH Parkinson Research Agenda (ninds.nih.gov/about_ninds/nihparkinsons_agenda.htm). The neuroprotectants to be tested in the trial have not yet been chosen and will be selected from among those proposed by the applicants who respond to this Request for Applications (RFA) as well as from those suggested by others, including NINDS grantees, pharmaceutical companies, patients, and patient advocates.

R21 Fast Track Grants for Parkinson's Disease Research (RFA-NS-02-006)

The National Institute of Neurological Disorders and Stroke (NINDS), The National Institute on Deafness and Other Communication Disorders (NIDCD), the National Institute of Environmental Health Sciences (NIEHS), the National Institute of Mental Health (NIMH), the Michael J. Fox Foundation for Parkinson's Research, the Parkinson's Disease Foundation/National Parkinson's Foundation, and the Parkinson Alliance invite investigator-initiated grant applications to conduct research relevant to the cure, cause, prevention or improved treatment of Parkinson's Disease (PD) and its complications. The intent of this RFA is to stimulate novel, innovative, or high impact approaches to the field of Parkinson's Disease research within the framework of the exploratory/developmental granting mechanism to enhance and escalate discoveries beneficial to PD.

Parkinson Disease Neuroprotection Clinical Trial: Coordinating and Statistical Centers (RFA-NS-01-012)

The Neurodegeneration and Clinical Trial Groups of the National Institute of Neurological Disorders and Stroke (NINDS) request applications for centers to collaborate in the performance of a large, double-blind randomized trial of two or more potential neuroprotective agents in patients early in the course of Parkinson's disease. Two types of applications are requested: for (1) a Coordinating Center, and (2) a Statistical Center. Applications for multiple Clinical Centers will be sought in a separate solicitation. The trial was called for in the NIH Parkinson Research Agenda. The neuroprotectants to be tested in the trial have not yet been chosen and will be selected from among those proposed by the applicants who respond to this Request for Applications (RFA) as well as from those suggested by others, including NINDS grantees, pharmaceutical companies, patients, and patient advocates.

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Notices

NINDS Administrative Supplements for Research on Human Embryonic Stem Cells (NOT-NS-02-007)

The National Institute of Neurological Disorders and Stroke (NINDS) announces a program for administrative supplements to foster basic and applied research on human embryonic stem cells (hESCs), and to allow investigators not currently working on hESCs to join the field. This supplemental funding initiative is issued in response to recommendations from DHHS Secretary Thompson calling for funding studies to compare the behavior of hESCs with that of other human stem cells, and stem cells from non-human species. This program is intended to facilitate research within ongoing, peer-reviewed projects that have Specific Aims on stem cell biology, or Specific Aims that may translate to the use of stem cells in pre-clinical studies of neurological dysfunction. These one-time supplements are intended to help NINDS grantees develop preliminary data for new applications to NINDS. Principal Investigators (PIs) funded by NINDS with Research Project (R01), Exploratory/Developmental (R21), Phase II SBIR (R44), Program Project (P01), and Specialized Center (P50 or U54) grants are eligible to apply.

NINDS Administrative Supplements: FDA-Approved Compound Screens for Neurodegeneration (NOT-NS-01-009)

The National Institute of Neurological Disorders and Stroke (NINDS), The Huntington's Disease Society of America (HDSA), The Amyotrophic Lateral Sclerosis Association (ALSA), The Hereditary Disease Foundation (HDF) announce an administrative supplement program of up to $1.3 million in Fiscal Year 2001. The program is intended to facilitate drug screens to identify new treatments for late onset neurodegenerative disorders through evaluation of FDA-approved compounds in disease models used or generated in ongoing, peer-reviewed, NINDS-funded projects. This administrative supplement program is issued in response to recommendations from the NINDS Strategic Plan and the Parkinson's Disease Research Agenda. Principal Investigators with Research Project (R01), Exploratory/Development (R21), FIRST (R29), Phase II SBIR (R44), Program Project (P01), and Specialized Center (P50 or U54) grants funded by NINDS are eligible to apply. To be eligible, projects must have a Project Period End Date of January 31, 2002 or later (a no cost extension beyond that date does not confer eligibility).

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Conferences, Workshops, and Seminars

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Udall Centers

None identified at this time.

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Special Events

Parkinson's Disease Research Web Launch

The NIH-wide Parkinson's disease research effort recently made another advance in public-private partnership with the launching of a new Parkinson's Disease Research Website (http://www.ninds.nih.gov/parkinsonsweb). The site, sponsored and maintained by NINDS, is designed for a broad group of users including scientists and clinicians, voluntary agencies, and patients, and provides information ranging from the full-length Parkinson's Disease Research Agenda and descriptions of NIH's funding opportunities and announcements to resources for patients and caregivers such as advocacy contact information. As the site continues to develop during the next several months, NINDS hopes to include information from all NIH Institutes-showcasing their parallel efforts on Parkinson's disease research.

Parkinson's Disease Research Supplements Awarded

The National Institute of Neurological Disorders and Stoke (NINDS) awarded 53 Parkinson's disease research supplements to grantees this Spring (2001). Last November (2000), NINDS announced an administrative supplement program of up to $3 million to foster additional research on Parkinson's Disease (PD) across a wide variety of scientific disciplines, and to allow investigators not currently working in PD to join the field. This supplemental funding initiative was issued in response to recommendations in the Parkinson's Disease Research Agenda, available on the NINDS website: NINDS Parkinson's Agenda Information calling for innovative funding mechanisms. The response of the NINDS grantee community to the research supplement was large, and over 95 requests were received for this innovative funding initiative.

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Last updated February 09, 2005