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Neurodegenerative Diseases clinical trials

View clinical trials related to Neurodegenerative Diseases.

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NCT ID: NCT01518374 Completed - Alzheimer Disease Clinical Trials

Clinical Evaluation of Florbetapir F 18 (18F-AV-45)

Start date: December 2009
Phase: Phase 2
Study type: Interventional

This protocol is designed to standardize imaging studies using florbetapir F 18 PET to provide information on amyloid burden in subjects participating in other studies (companion protocol) such as longitudinal studies of aging and studies of biomarkers for neurodegenerative diseases.

NCT ID: NCT01498263 Completed - Clinical trials for Alzheimer's Disease and Related Dementias

Inherited Diseases, Caregiving, and Social Networks

Start date: January 9, 2012
Phase:
Study type: Observational

Approximately 66 million informal caregivers care for someone who is ill, disabled, or aged. These caregivers experience significant distress associated with caregiving, which may be particularly salient in the context of inherited conditions. Previous studies have not examined caregiving from a network perspective, nor have they considered how cognitive and emotional responses, such as caregivers worry for themselves and relatives acquiring the disease or guilt related to the genetic etiology of their child s illness, as possible stressors; the current project fills this literature gap. Caregiving processes may vary across type of illness and the life course. In illnesses that impact children, parents and grandparents may take on caregiving roles whereas in conditions that impact adults, spouses and adult children may provide care. Caregivers must adapt to the strain of caring for their affected relatives and this adaptation may differ depending on caregiver roles. The caregiver s support network may influence adaptation, impacting the health and well-being of patients, their caregivers, and other relatives. This project, comprised of 5 substudies, will examine social contexts surrounding families involved in caring for individuals with chronic inherited conditions from a relational perspective. Surveys and interviews will assess participants cognitions and emotions about the disease, caregiving burden and caregiving/support network systems. In addition, biomarkers will be considered in 2 substudies to examine how caregiving roles and expectations impact health among caregivers. As part of our current inquiry, we have developed an assessment tool aimed at understanding caregiver experiences related to dietary practices in the context of metabolic conditions. To evaluate the psychometric properties of this scale, we propose a fifth substudy under the current protocol. We aim to recruit at least 5550 participants through residential/daycare centers, advocacy groups, and the NIH Clinical Center. We will recruit formal caregivers, multiple biological and non-biological adult relatives of affected individuals and typically developing controls to construct and evaluate caregiving/support network systems. This project will use a social network framework to develop and adapt common measures of caregiving roles to evaluate burden, perceptual bias, and unmet expectations in caregiving. The psychometric properties of these new measures, characteristics of family caregiving and support networks, and how these network characteristics are associated with caregiving strain and well-being, including biomarkers of physical health, will be investigated. The moderating role of family members cognitions and emotions and disease context will be considered. Findings will guide future research to develop network-based interventions promoting positive adaptation to the presence of inherited conditions in families through improved social environments and coping skills....

NCT ID: NCT01495390 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

A Longitudinal Study of Amyotrophic Lateral Sclerosis (ALS) Biomarkers

Start date: November 2011
Phase: N/A
Study type: Observational

The purpose of this study is to collect biofluid samples for the banking and usage in ALS research. Through comparison of these samples, the researchers hope to learn more about the underlying cause of ALS, as well as find unique biological markers, which could be used to develop new therapies.

NCT ID: NCT01487395 Completed - Alzheimer Disease Clinical Trials

Prediction of Cognitive Properties of New Drug Candidates for Neurodegenerative Diseases in Early Clinical Development

PharmacogWP3
Start date: December 2011
Phase: Phase 1
Study type: Interventional

The early assessment of new drugs for Alzheimer's disease remains difficult because of the lack of predictive end-point. The use of a battery including different parameters could improve this early development of new drugs. Nevertheless, the interest of such a battery should previously be validated with the yet marketed AD drugs

NCT ID: NCT01453127 Enrolling by invitation - Dementia Clinical Trials

DaTSCAN Imaging in Aging and Neurodegenerative Disease

Start date: October 2011
Phase: Phase 4
Study type: Interventional

The investigators propose using DaTscan in patients with REM sleep behavior disorder (RBD), mild cognitive impairment (MCI), Parkinson's disease (PD), dementia with Lewy bodies (DLB), Alzheimer's disease (AD), and other neurodegenerative syndromes and disorders, to test several hypotheses - some confirmatory, and some novel. Such use will provide new data on the potential clinical and research utility of DaTscan in neurodegenerative diseases. The findings on DaTscan will be correlated with clinical diagnoses and other multimodal imaging studies (e.g., MRI, MRS, FDG-PET, and amyloid-PET) to enhance our understanding of neurodegenerative diseases.

NCT ID: NCT01450891 Completed - Clinical trials for Neurodegenerative Diseases

Health Technology Assessment of Diagnostic Approaches in Alzheimer's Disease

Start date: September 2009
Phase: N/A
Study type: Observational

Background: New research criteria for the diagnosis of Alzheimer's disease (AD) have recently been developed to enable an early diagnosis of AD pathophysiology by relying on emerging biomarkers. To enable efficient allocation of health care resources, evidence is needed to support decision makers on the adoption of emerging biomarkers in clinical practice. The research goals are to 1) assess the diagnostic test accuracy (of current clinical diagnostic work-up and emerging biomarkers in Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET) and Cerebrospinal Fluid (CSF), 2) perform a cost-consequence analysis and 3) assess long-term cost-effectiveness by an economic model. Methods/design: In a cohort design 304 consecutive patients suspected of having a primary neurodegenerative disease are approached in four academic memory clinics and followed for two years. Clinical data and data on quality of life data, costs and emerging biomarkers are gathered. Diagnostic test accuracy is determined by relating the clinical practice and new research criteria diagnoses to the reference diagnosis. The clinical practice diagnosis at baseline is reflected by a consensus procedure among experts using clinical information only (no biomarkers). The diagnosis based on the new research criteria is reflected by decision rules that combine clinical and biomarker information. The reference diagnosis is determined by a consensus procedure among experts based on clinical information on the course of symptoms over a two-year time period. A decision analytic model is build combining available evidence from different resources among which (accuracy) results from the study, literature and expert opinion to assess long-term cost-effectiveness of the emerging biomarkers. Discussion: Several other multi-centre trials study the relative value of new biomarkers for early evaluation of AD and related disorders. The uniqueness of this study is the assessment of resource utilization and quality of life to enable an economic evaluation. The study results are generalizable to a population of patients who are referred to a memory clinic due to their memory problems.

NCT ID: NCT01384825 Completed - Multiple Sclerosis Clinical Trials

Observational Study of the Prevalence of CCSVI in Multiple Sclerosis and in Other Neurodegenerative Diseases

COSMO
Start date: December 2010
Phase: N/A
Study type: Observational

The presence of abnormalities in the cerebral venous circulation, defined as Chronic Cerebrospinal Venous Insufficiency (CCSVI), has recently been reported in patients with Multiple Sclerosis (MS), in healthy subjects and in subjects with other neurological diseases. These reports have aroused much interest both in the scientific world and, above all, among the communities of patients and Associations having the aim of aiding people with MS and of promoting scientific research into this disease. In the literature published so far there is a lack of verification in large samples of the prevalence of CCSVI in MS compared with that observed in healthy subjects and in those with other diseases of the nervous system. This is an observational study investigating the prevalence of CCSVI in subjects with MS and comparing it with the prevalence observed in a control population consisting of Healthy Controls (HC) and in a population affected by other neurological diseases of the central nervous system of degenerative, vascular, inflammatory and autoimmune origin. A total of at least 1,200 adults with MS will be included in the study, as well as 400 healthy subjects and 400 subjects with other neurodegenerative diseases.

NCT ID: NCT01291550 Recruiting - Clinical trials for Neurodegenerative Diseases

Electronic Nose for Diagnosis of Neurodegenerative Diseases Via Breath Samples

Start date: September 2010
Phase: N/A
Study type: Observational

The diagnosis of neurodegenerative conditions and ADHD still mostly relies on clinical symptoms as there are no validated, inexpensive, and simple bio- markers available yet. The purpose of this study is to deliver a proof-of-concept for novel biomarkers to identify neurodegenerative conditions and ADHD based on breath testing. Alveolar breath will be collected from healthy volunteers, patients with extrapyramidal conditions, patients diagnosed with dementia and from ADHD subjects. The discriminative power of a tailor-made Nanoscale Artificial Nose (™NA-NOSE) containing an array of six nanomaterial-based sensors will be tested. Discriminant factor analysis will be applied to the NA-NOSE signals in order to detect statistically significant differences between the sub-populations, and classification success will be estimated using leave-one-out cross-validation. The identification of NA-NOSE patterns will be supported by analyzing the chemical composition of the breath using gas-chromatography in conjunction with mass-spectrometry (GC-MS).

NCT ID: NCT00999934 Recruiting - Clinical trials for Ocular-motor and Vestibular Diseases

Neural Mechanisms Engaged in Control of Eye Movements

Start date: July 2009
Phase: N/A
Study type: Observational

The purpose of eye movements is to ensure clear, optimal vision. In order to see clearly, images must be held steady on the retina. Best visual acuity is achieved when the image of the object of interest is brought to and held on the fovea of the retina. Two main types of eye movements are responsible for that: those that keep images stable on the retina (gaze holding mechanisms) and those that change the line of sight (gaze shifting mechanisms). Several functional classes of eye movements have been defined; each has distinctive physiological properties that suit best to its particular task. Thus, vestibular and optokinetic eye movements hold images of the seen world steady on the retina during perturbations of the head. Saccades are rapid eye movements that bring the image of an object of interest, detected in the periphery of vision, onto the fovea where it can be seen best. Smooth pursuit eye movements place the images of a moving target close to fovea. Vergence eye movements place the images of a single object simultaneously onto both foveae. Each functional class of eye movements relies on a different neural substrate. The clinical significance of it is that impairment of a specific class of eye movement points to involvement of distinct structures or pathways within the brain. Thus, abnormalities of ocular motility are often the clue to the anatomical localization of neurological disorders. Significance: This study will contribute to understand how the brain governs production of eye movements, and provide better insight on interaction between sensory (visual) and motor (eye movement) system, i.e. sensory-motor interaction. It will also contribute to identify pathophysiological mechanisms underlying human diseases and will improve the investigators' ability to diagnose and encourage development of new therapeutic strategies. Methods: The investigators will measure eye and head movements using the magnetic scleral search coil technique. The magnetic search coil technique is the most sensitive and accurate technique used in modern ocular motor and vestibular research for measuring horizontal, vertical and torsional eye movements. The coils are easy to apply and well tolerated over a wearing period of up to 45 minutes per recording session. Population: A grand total of about 250 individuals (normal subjects and patients) will be recruited for the study. Patients will be recruited from the in- and out-patients of the Neurology and Neuro-ophthalmology services of Meir Medical Center. Healthy normal subjects will be recruited from faculty and staff of Meir Medical Center. Criteria for inclusion/exclusion: The investigators will study patients with neurological disorders causing abnormal eye movements: Degenerative CNS diseases, extrapyramidal disorders, Spino-cerebellar ataxias, Cerebrovascular diseases, demyelinating diseases, Ocular motor and vestibular palsies, Mitochondrial and other ocular myopathies. Only patients who are medically stable and are able to give informed consent will be included in the study. Criteria for excluding subjects will include eye disease such as corneal or scleral abrasion or disease, glaucoma, refractive errors greater than 2 diopters and concurrent medication with CNS-active agents.

NCT ID: NCT00990379 Active, not recruiting - HIV Infections Clinical Trials

Using Heavy Water to Study Cell Dynamics in Parkinson's Disease

Start date: April 2009
Phase: N/A
Study type: Observational

This pilot study will assess the feasibility of using heavy water as a safe 'tracer' for biomarker studies of diseases of the brain and spinal cord, that, together, are also called the central nervous system (CNS). Heavy water, also called deuterated water or D20, is the same as normal drinking water except the hydrogen atoms have been replaced by deuterium, a naturally occurring isotope of hydrogen. In particular, this study will use heavy water to define: 1) The rate of immune cell proliferation (growth) in the cerebrospinal fluid (CSF) compared to blood. This study will be examining a particular type of immune cell called T lymphocytes. 2) This study will also examine selected molecules generated by nerve cells of the CNS to understand their rate of secretion and turnover in healthy control participants, HIV-1-infected participants and participants with a non-HIV-related neurodegenerative disease such as Parkinson's disease (PD). This study will involve the administration of heavy water orally for either seven days, 12 days or six weeks. Measurements will be taken by lumbar puncture (LP, also known as a spinal tap). Blood (approximately five tablespoons per visit) will also be obtained at each of the lumbar puncture appointments. If this method can be used to establish the rates of immune cell turnover and the production rates of neuronal molecules using cerebrospinal fluid, it will provide unique data that is important to understand chronic neurodegenerative conditions, like PD, and to measure responses to targeted therapies. Hypothesis: 1. D2O, administered orally, can be used to measure the proliferation rates of CSF T cells (and, eventually, of their major phenotypic subsets). 2. D2O can be used to assess the turnover and production rates of CNS constituents that are normally or pathologically shed or secreted into the CSF, including (eventually): cargo molecules transported specifically in neurons in the CNS, such as chromogranin-A and -B, neuregulin-1 (specifically the extracellular secreted ectodomain of neuronal differentiation factor (NDF) isoform type α1, α2, β1, and the acetylcholine receptor inducing activity isoform (ARIA), secreted amyloid precursor protein (sAPP), alpha-synuclein; and APP metabolites amyloid beta (Aβ) 41 and 42.