45 Clinical Trials for Various Conditions
The study hypothesis is that cenicriviroc will improve cognition in HIV infected individuals with cognitive impairment. The investigators will study the effect of cenicriviroc on cognition in 24 subjects over a 24 week period.
1. This study will evaluate the association between changes in basic cognitive and behavioral functioning by the end of chemotherapy treatment, and the later development of higher order executive functions in pediatric acute lymphoblastic leukemia (ALL). 2. The association between acute treatment-related changes in brain integrity and subsequent brain maturation in long-term survivors of pediatric ALL will be evaluated. 3. The association between patterns of behavioral and executive dysfunction and brain maturation in long-term survivors of pediatric ALL will be examined. 4. The association between genetic polymorphisms in key enzyme pathways and higher order brain development in long-term survivors of pediatric ALL will be explored. 5. The associations between biologic and behavioral indices of fatigue/sleep and higher order brain development in long-term survivors of pediatric ALL will be explored.
Despite the advent of highly active antiretroviral therapy (HAART), the prevalence of neurocognitive impairment among HIV-infected patients continues to be an important issue. Although severe forms of AIDS-related dementia have diminished, milder forms of cognitive impairment have been noted among approximately 30% of asymptomatic HIV patients. Studies among HIV-infected U.S. military personnel regarding neurocognitive function have largely been limited to the early 1990s, before the advent of HAART. In these studies subtle neurobehavioral changes were noted among asymptomatic HIV-positive military personnel. This study proposes to determine the prevalence of neurocognitive deficits among HIV-positive military beneficiaries during the era of HAART who are participants of the U.S. Military HIV Natural History Study. The prevalence ascertained in this study will be compared to HIV-negative military beneficiaries who are demographically similar to the HIV positive group. The sample size of the study is to have complete testing on 200 HIV positive and 50 HIV-negative participants; due to the possibility of attrition before study completion, the investigators will enroll up to 300 participants (240 HIV-positive and 60 HIV-negative) to achieve this sample size. The investigators' rates among HIV-positive patients found in this study will also be contextualized in the setting of the prevalence of prior neurocognitive deficits seen in a HIV positive U.S. military population studied in the 1990s, contemporary rates among civilian HIV-infected persons, and normative values in the general HIV-negative population. Compared to other data in the field of neuropsychology, this study is novel in that the HIV population studied is composed largely of HIV patients who have been diagnosed early in their HIV infection; have open, free access to antiretrovirals to begin therapy earlier than most other cohorts; and consists of highly-functioning, educated individuals.
RATIONALE: Gathering information about how often problems with neurocognitive functioning occur in patients with newly diagnosed upper aerodigestive tract cancers may help doctors learn more about the disease. PURPOSE: This clinical trial is studying neurocognitive functioning in patients with newly diagnosed upper aerodigestive tract cancers receiving treatment at Henry-Joyce Cancer Clinic.
There is evidence that survivors of childhood cancer have a high prevalence of poor sleep, including symptoms of insomnia. Insomnia is highly comorbid and has been associated with impaired cognitive performance, a range of psychiatric disorders, cardiovascular disease, and reduced quality of life. However, we still lack knowledge about the direct impact of available internet-based insomnia treatment programs for survivors of childhood cancer experiencing insomnia, in addition to how improving insomnia symptoms impacts neurocognitive function and late health morbidities in this population. Therefore, in this study, we will utilize the resources available in the Childhood Cancer Survivor Study (CCSS) to use an accepted, established, efficacious internet-delivered CBTi insomnia treatment program and evaluate the efficacy of this program in adult survivors of childhood cancer. Positive results from this study and our use of an internet-based intervention are likely generalizable and be scalable to the large and geographically diverse population of childhood cancer survivors with chronic health conditions. Primary Objective To examine the efficacy of an eHealth intervention for improving symptoms of insomnia among adult survivors of childhood cancer. Secondary Objectives To examine the impact of an eHealth intervention for insomnia on the clinical severity of insomnia symptoms in adult survivors of childhood cancer. To determine whether treatment of insomnia symptoms will improve neurocognitive function in adult survivors of childhood cancer with both insomnia and neurocognitive impairment. To explore the mediating effects of improved neurocognitive function, emotional distress, and cardiovascular health on the association between insomnia symptoms and quality of life.
Randomized control pilot 12 week feeding trial to compare the preliminary effects of ketogenic diet (versus patient choice diet) on HIV-associated neurocognitive impairment. N = 20 (n = 10/10) randomized to diet condition. Pilot data necessary to evaluate the feasibility and determine initial data for primary outcomes in order to accurately determine needed sample size for larger clinical trial. Outcomes: 1) cognition (NIH Toolkit), 2) cardiometabolic markers (insulin glucose, insulin resistance, markers of inflammation), and 3) neural activity (as determined by functional MRI..
Background: - Human immunodeficiency virus (HIV) infection appears to cause problems with blood vessel function. These problems may add to some thinking and mood disorders found in people with HIV infection. Researchers want to evaluate HIV infected patients to see if blood vessel function contributes to thinking and mood disorders, such as early dementia and depression. To do so, they will compare study results between people with and people without HIV infection. Objectives: * To compare the thickness of blood vessel walls between people with and without HIV infection. * To study the relationship between blood vessel thickness and thinking and mood disorders. Eligibility: * Individuals between 25 and 55 years of age who have HIV infection. * Healthy individuals between 25 and 55 years of age. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. * Participants will have imaging studies of the brain and major blood vessels in the head and neck. * Participants will also have neuropsychological testing. These tests will look at memory, learning and thinking ability, attention, and mood. * Participants will have the option of coming back for repeat blood tests every six months and repeat imaging studies and neuropsychological tests every year, over 1- 4 years period.
This longitudinal project will investigate a common complaint of women who receive chemotherapy for breast cancer- cognitive difficulty. The relationships of fatigue, stress, and depression to cognitive difficulties will be examined. The findings should lead to interventions to decrease the effects of these problematic side effects.
To investigate factors that predict cognitive enhancement following engagement in an intensive Computerized Cognitive Training Protocol.
Long-term survivors of ALL are at-risk for neurocognitive impairment, particularly in the area of executive functioning. Relatively limited research has focused on interventions for improving neurocognitive outcomes in long-term survivors of ALL. A promising technique for cognitive enhancement is Transcranial Direct Current Stimulation (tDCS) which differs from conventional cognitive remediation approaches in that it directly stimulates specific brain regions responsible for cognitive processes and activates functional networks similar to those activated during cognitive training. Primary Objective To evaluate the efficacy of home-based transcranial direct current stimulation (tDCS) paired with remote cognitive training on direct testing of executive function in survivors of ALL. Secondary Objectives * To evaluate the efficacy of home-based transcranial direct current stimulation (tDCS) paired with remote cognitive training on patient-reported symptoms of executive dysfunction in survivors of ALL. * To examine the effects of home-based tDCS paired with remote cognitive training on patterns of regional brain activation as measured by functional magnetic resonance imaging. * To examine the effects of home-based tDCS paired with remote cognitive training on white matter integrity and structure as measured by diffusion tensor imaging.
This study leverages a modernized digital version of a well-known cognitive screening tool to examine pre and post operative cognitive function after surgery in adults age 65 years or more. Machine learning algorithms will be applied to the hospital wide standard of care cognitive metric to identify risk for post-operative cognitive complications.
Primary objective: 1. To examine the efficacy of melatonin treatment on neurocognitive functioning in adult survivors of childhood cancer. Secondary objectives: 1. To evaluate the efficacy of melatonin treatment on delayed sleep onset latency in long-term childhood cancer survivors. 2. To investigate whether improvement in sleep onset latency due to melatonin treatment is associated with neurocognitive improvement in long-term childhood cancer survivors. This study is a randomized double-blind placebo controlled trial of time release melatonin for adult survivors of childhood cancer who demonstrate impaired neurocognitive functioning and/or difficulty falling asleep.
The purpose of this study is to see if paroxetine and fluconazole are safe and effective as a treatment for problems with memory, concentration, thinking, and judgment in people who are infected with HIV. Paroxetine is an antidepressant approved by the FDA to treat major depression. Fluconazole is an antifungal medication approved by the FDA to treat fungal infections.
This study will document the cognitive (mental) and functional abilities of newly diagnosed cancer patients. The study will also examine the changes in cognitive and functional abilities during and after chemotherapy (your cancer treatment). A comprehensive set of questionnaires and tasks, or assessments, have been put together in order for doctors and nurses to learn more about the day to day functioning of newly diagnosed adult cancer patients. The investigators would also like to follow up with the same adult patients, during and following completion of their cancer treatment, to learn about the kinds of treatments they received and how their cognitive status and level of participation in activities of daily living has changed. With follow-up assessments, doctors and nurses can learn more about the complications or health problems that adult patients may experience as a result of undergoing cancer therapy. This is a study involving two visits. The first visit occurs within two weeks before starting your cancer therapy, specifically chemotherapy. The second visit occurs within two weeks of completing your chemotherapy.
The proposed research is relevant to public health because stroke is a leading cause of long-term disability among older adults and communication impairments resulting from stroke have a significant negative impact on quality of life. By seeking to better understand post-stroke aphasia, this project lays the groundwork for development of new interventions, and aligns with NIDCD's priority areas 1 (understanding normal function), 2 (understanding diseases), and 3 (improving diagnosis, treatment, and prevention).
This protocol focuses on the effect of sleep interventions on improving sleep and building cognitive/brain resilience in older adults with amnestic mild cognitive impairment and sleep disturbance. Two sleep interventions, cognitive behavioral therapy for insomnia (CBTI) and acoustic slow-wave activity enhancement (SWAE), will be utilized in a pilot randomized clinical trial in which participants are randomized to different treatment groups (CBTI or SWAE). Participants will be assessed over a 6-month period in order to examine the impact of sleep treatments on neuropsychological outcomes and cognitively mediated everyday functioning.
This randomized controlled trial will evaluate the impact of an Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) intervention on sleep and the extent to which it contributes to cognitive health in individuals with mild cognitive impairment. Participants with insomnia who meet the study criteria for mild cognitive impairment will be recruited to determine the effects of the CBT-I intervention compared to a patient education condition on sleep and cognition. Internet-based recruitment methods will be used, and outcomes include sleep variables, daytime variables, and cognitive status.
Children with neurofibromatosis are more likely to have difficulties related to their psychological and neurocognitive functioning (e.g., more likely to have depression, have social difficulties, be diagnosed with ADHD). The purpose of this randomized control study is to determine how effective and useful this study's single session intervention can be in improving psychological and neurocognitive functioning. Enrolled families will consist of one parent/guardian and child. Parents and patients will complete questionnaires and objective tests at baseline, 3 months, and 6 months. Families randomized to the intervention arm will be provided with one single session intervention at Month 1 to learn about their child's testing results and receive psychoeducation and recommendations related to psychological and neurocognitive functioning.
The research objective of this study is to examine the efficacy of HD-tDCS to the preSMA/DACC region and its influence on verbal episodic memory in patients with MCI or dementia after 10 sessions of HD-tDCS. There will be three treatment arms: two active HD-tDCS (1 mA or 2 mA) and a sham group. A verbal episodic memory task will be completed at baseline, immediately following the last HD-tDCS session, and a 2-month follow-up.
Despite the availability of numerous cognitive assessment tools, cognitive impairment related to dementia is frequently under-diagnosed in primary care settings. The investigators have developed a 5-minute cognitive screen (5-Cog) coupled with a decision tree to overcome the technical, cultural and logistic barriers of current cognitive screens to improve dementia care in primary care patients with cognitive concerns.
This study will evaluate the safety, tolerability, and potential effects on cognition of GRF6021, a plasma-derived product, administered as an intravenous (IV) infusion, to subjects with Parkinson's disease and cognitive impairment.
The goal of this study is to test the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) as a treatment for Mild Cognitive Impairment (MCI). Participants will be randomly assigned to one of three treatment groups: Group 1: Active Dorsolateral Prefrontal Cortex (DLPFC) rTMS; Group 2: Active Lateral Parietal Cortex (LPC) rTMS; and Group 3: Inactive rTMS (Placebo) control (evenly split between each coil location). Participation in the study takes approximately 7 ½ months-including a 2-to 4-week treatment phase (20 rTMS sessions) and a 6-month follow-up phase.
Behavioral interventions currently provide the most useful approach to addressing the behavioral and social needs of those with Mild Cognitive Impairment (MCI) due to Alzheimer's or other diseases. This randomized, multisite, 3-arm study will investigate the impact of computerized brain fitness vs yoga vs an active control group (wellness education) on changes in cognitive function, daily functioning and quality of life in persons with Mild Cognitive Impairment (MCI) and their partner. In addition, in vivo neuroimaging measures of plasticity during the pre- and post-intervention periods will be measured and compared between the three different treatment groups. These neuroimaging measures of plasticity will be investigated in their relationship to the cognitive outcomes within each group.
The purpose of this study is to determine the efficacy of Mindfulness Based Stress Reduction (MBSR) to alleviate stress, anxiety, and depressive symptoms, and improve attention among patients aged 60 or older who suffer from HIV-associated neurocognitive disorders (HAND) and have maximized treatment options.
Whereas the advantageous effects of exercise-training on memory is increasingly recognized, the practicality and clinical usefulness of such interventions in community-dwelling older African Americans (AA)s Mild Cognitively Impaired (MCI) subjects, and the mechanism by which an effect occurs need elucidation. Because aerobic-exercise can improve emerging cardiovascular (CVD)-related risk factors for cognitive decline such as lipids, inflammatory cytokines and glucose homeostasis; the Investigators will examine training effects on these and related biomarkers. The imperative for this study is further underscored by the fact that, AAs: i) have high rates of dementia, and ii) have paucity of cross-sectional, and lack prospective data on the effects of exercise on cognition. To overcome barriers to recruitment and retention, enhance compliance with a long exercise program (3-times/week), and maximize the use of available resources, the Investigators will use a community-based approach. Therefore, the primary objectives of this study build on the Investigators' experience, and will compare the effects of aerobic-exercise to stretch-exercise (control) in community-dwelling AA MCI subjects. Following the initial 6 months active intervention, the aerobic-exercise group will follow a prescribed but free living 40 minutes, 3 time/week exercise regimen while the control group returns to usual care plus stretch-exercise for additional 12 months. This study will facilitate the estimation of sample size for a larger confirmatory study in AAs. A newly acquired direct oversight of the DC Ward-6 Senior Wellness Center and its infrastructures by the Howard University Division of Geriatrics will provide additional resources and access to the community. In addition to the Investigator's feasibility aims, the Investigators will determine performance on cognitive tasks using the Alzheimer's Disease Assessment Scale-Cognitive Sub-scale (ADAS-Cog) and Clinical Dementia Rating Scale (CDR) sum of boxes supplemented by tests of executive function (EF) and Functional Activity Questionnaire (FA) and together as ADAS-Cog-Plus; changes in brain volume regions of interest (ROI) with Magnetic Resonance Imaging (MRI), selected CVD and AD-related bio-markers.
This research study will evaluate a standalone software application and is designed to standardize and validate new neurocognitive screening testing for children aged 6 through 11, and adolescents and adults ages 12 through 75. The purpose of this study is to evaluate recently developed computerized tasks sensitive to changes in neurocognitive performance after a concussion. These tests were designed to help measure the effects of concussion on cognitive processes (e.g., memory, attention, brain speed) and visual functioning.
This randomized phase III trial compares memantine hydrochloride and whole-brain radiotherapy with or without hippocampal avoidance in reducing neurocognitive decline in patients with cancer that has spread from the primary site (place where it started) to the brain. Whole brain radiotherapy (WBRT) is the most common treatment for brain metastasis. Unfortunately, the majority of patients with brain metastases experience cognitive (such as learning and memory) deterioration after WBRT. Memantine hydrochloride may enhance cognitive function by binding to and inhibiting channels of receptors located in the central nervous system. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Using radiation techniques, such as intensity modulated radiotherapy to avoid the hippocampal region during WBRT, may reduce the radiation dose to the hippocampus and help limit the radiation-induced cognitive decline. It is not yet known whether giving memantine hydrochloride and WBRT with or without hippocampal avoidance works better in reducing neurocognitive decline in patients with brain metastases.
Purpose: This is a prospective single-center, randomized, patient and evaluator-blind clinical trial to compare the neurocognitive outcomes of globus pallidus interna (GPi) versus subthalamic nucleus (STN) deep brain stimulation (DBS) in Parkinson's disease (PD) patients with mild cognitive impairment (MCI).
This randomized, controlled trial (RCT) evaluates the benefits of memory and problem solving training compared to supportive therapy in individuals with Parkinson's Disease with Mild Cognitive Impairment (MCI) and their support persons. Participants will be randomly assigned to receive memory and problem solving training or supportive therapy for 2-months. A 6-month follow up evaluation will establish if benefits remain over time. Impact of these therapies on thinking abilities, physical health, and patient and support person ratings of thinking skills, mood and quality of life will be evaluated. The memory and problem solving training is hypothesized to result in greater improvements and/or stability of function on neuropsychological tests of attention, working memory, learning, and memory skills compared to the supportive therapy condition. Both conditions are hypothesized to result in improved mood and quality of life ratings. Results from this study will determine whether memory and problem solving therapies and supportive therapy are easily used by and beneficial for individuals with Parkinson's Disease and Mild Cognitive Impairment. If positive benefit is observed, information from this study will be used to further optimize these therapies for larger trials designed to evaluate the value of the therapies for individuals with Parkinson's Disease and their support persons.
Late-life depression (LLD) and cognitive impairment (CI) are significant public health problems among older adults, and their co-occurrence markedly increases disease burden and dementia risk. This highlights the importance of identifying and treating CI in LDD; however, current lack of reliable prognostic information from clinical, neuroimaging, and genetic data impedes research on targeted prevention and treatment. Two critical ways to close current knowledge gaps in predicting cognitive diagnostic outcomes of LLD involve: 1) increasing the number of diagnostic cases available to existing studies, and 2) using those studies to identify clinical, imaging, and genetic predictors that will improve future diagnosis. We intend to do both in the current proposal. We plan to study the following SPECIFIC AIMS: Aim 1: Identify baseline clinical-behavioral predictors of cognitive diagnostic outcomes in LLD. Working hypothesis: During acute LLD, CN will be associated with more frequent EOD and higher negative life stress than PCI and AD; PCI will be associated with EOD and higher frailty than CN and AD; AD will be associated with LOD, greater appetite loss, lower anxiety, and greater memory impairment than CN and PCI. Aim 2: Use multimodal neuroimaging at baseline to identify patterns associated with cognitive diagnostic outcomes in individuals with LLD. Working Hypothesis: CN will be associated with greater white matter integrity compared with PCI and AD; PCI will be associated with lower white matter integrity and network abnormalities in anterior cingulate cortex compared with CN; AD will be associated with lower hippocampal volume compared with CN and PCI. Aim 3: (exploratory): Explore interrelationships among candidate genes, cognitive diagnostic outcomes, and proposed phenotypic components relevant to LLD. Exploratory Hypotheses: 1) COMT val158met polymorphism will be associated with CN; 2) 5-HTTPRL and APOE ε2 polymorphisms will be associated with frailty; 3) genetic variation (SNPs) in TPH2 and AGTR1 will be associated with risk factors of AD: LOD, episodic memory, hippocampal volume, and appetite loss.