27 Clinical Trials for Various Conditions
This is a pilot randomized trial of rTMS for symptoms of fatigue and brain fog, and other neuropsychiatric symptoms of Long-COVID (Post-COVID, post-acute sequelae of COVID-19 infection, PASC). Twenty participants diagnosed with Long-COVID and recruited from the UCLA Long-COVID clinic will be randomized to receive active rTMS versus sham stimulation for 15 treatments followed by another 15 open-label rTMS treatments. Investigators will compare the safety and tolerability of rTMS vs Sham and examine within-group changes in symptoms of fatigue, sleep, pain, mood, and subjective and objective cognitive impairment. This project will provide information and pilot data for future larger clinical trials.
This is a pilot study to explore the effects of pimavanserin and low-dose quetiapine in subjects with Parkinson's disease with neuropsychiatric symptoms.
Recent findings suggest that sleep disruption may contribute to the generation and maintenance of neuropsychiatric symptoms including anxiety, depression, agitation, irritation, and apathy while treating sleep disruption reduces these symptoms. Impairments in the neural systems that support emotion regulation may represent one causal mechanism mediating the relationship between sleep and emotional distress. However, this model has not yet been formally tested within a sample of individuals with or at risk for developing Alzheimer's Disease (AD) This proposal aims to test a mechanistic model in which sleep disturbance contributes to neuropsychiatric symptoms through impairments in fronto-limbic emotion regulation function in a sample of individuals at risk for developing, or at an early stage of AD. This study seeks to delineate the causal association between sleep disruption, fronto-limbic emotion regulation brain function, and neuropsychiatric symptoms. These aims will be achieved through a mechanistic, randomized 2-arm controlled trial design. 150 adults experiencing sleep disturbances and who also have cognitive impairment with the presence of at least mild neuropsychiatric symptoms will be randomized to receive either a sleep manipulation (Cognitive Behavioral Therapy for Insomnia CBT-I; n=75) or an active control (n=75). CBT-I improves sleep patterns through a combination of sleep restriction, stimulus control, mindfulness training, cognitive therapy targeting dysfunctional beliefs about sleep, and sleep hygiene education. Neuropsychiatric symptoms, fronto-limbic functioning, and sleep disruption will be assessed at baseline and at the end of the sleep manipulation through functional Magnetic Resonance Imaging (fMRI), clinical interviews, PSG recordings, and self-report questionnaires. Neuropsychiatric symptoms (anxiety and depression) and sleep disturbance (actigraphy, Insomnia Severity Index, and sleep diaries) will be assayed at baseline and each week throughout the sleep manipulation to assess week-to-week changes following an increasing number of CBT-I sessions. Wristwatch actigraphy will be acquired from baseline to the end of the sleep manipulation at week 11. Neuropsychiatric symptoms and sleep will be assessed again at six months post-manipulation.
Patients with Alzheimer's disease (AD) are increasingly recognized to have seizures in addition to cognitive decline. Seizures may contribute to memory problems as well as other symptoms common in AD like agitation, depression, or apathy. These symptoms are collectively called neuro-psychiatric symptoms. Studies of magnetic resonance imaging (MRI) in patients with AD have suggested that injury to certain parts of the brain can cause these neuro-psychiatric symptoms. Based on this evidence, the investigators hypothesize that seizures can also cause neuro-psychiatric symptoms in patients with AD and may be related to the injury seen on MRI. The current study will follow participants for 1 year and will involve participants with AD who also have neuro-psychiatric symptoms. Participants will be examined with three brain wave studies to assess for seizure-like activity. Participants with seizure-like activity will all receive levetiracetam for 1 year. All participants will have their neuro-psychiatric symptoms, cognitive abilities, quality of life, and AD severity assessed throughout the year. The investigators plan to determine if levetiracetam changes the severity of the participants' neuro-psychiatric symptoms compared to their baseline as well as compared to participants without seizure-like activity. 65 participants will need to be recruited to test the study hypotheses. The study will take place at Walter Reed National Military Medical Center.
The purpose of this study is to evaluate the long-term safety and tolerability of pimavanserin in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease exposed to open-label pimavanserin for up to 52 weeks.
The purpose of this study is to assess the safety and tolerability of pimavanserin compared to placebo in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease.
This study evaluates the effect of transcranial direct current stimulation (tDCS) on non-motor symptoms of Parkinson's disease, including depression and cognitive symptoms. Participants are randomized to receive active or sham tDCS for 30 minutes over 10 treatment sessions.
Traumatic brain injury (TBI) is frequently complicated by depression and other problems such as post traumatic stress disorder (PTSD), sleep disturbance, cognitive deficits and behavioral problems. Untreated depression can lead to reduced productivity and poor global outcome. There is no Food and Drug Administration (FDA) approved drug for the treatment of TBI-related depression. The overarching goal of this small study is to determine the effectiveness of low frequency right (LFR) rTMS for the treatment of post-TBI depression and co-occurring psychiatric symptoms. Repetitive transcranial magnetic stimulation (rTMS) is a brain stimulation technique. It involves generating a brief magnetic field in a coil that is placed on the scalp. The magnetic field passes through the skull and induces a weak electrical current in the brain that briefly activates neural circuits at the stimulation site. Adults aged 18 and older, with a history of head injury of mild or moderate severity , who are currently experiencing symptoms of clinical depression may join the study.
This study will evaluate safety and efficacy of PF-05212377 in subjects with mild-to-moderate Alzheimer's Disease with existing neuropsychiatric symptoms on a stable dose of Donepezil. The 4-week run-in will minimize placebo effect. The 12-week treatment period is considered the minimum length necessary to reliably evaluate the effect PF-05212377 on cognition and and neuropsychiatric symptoms in this population. The 2-week washout will allow to monitor re-emergence of neuropsychiatric and cognitive symptoms.
This double-blind, placebo-controlled, randomized study is designed to evaluate the safety and therapeutic effects of sapropterin dihydrochloride on neuropsychiatric symptoms in subjects with PKU.
This research will examine the impact of brain activity, cognitive processing immune functioning, and gastrointestinal functioning on depressive symptoms and response to a psychotherapeutic intervention in youths with Inflammatory Bowel Disease (IBD).
Study objective is to compare neuropsychiatric adverse events in subjects treated with varenicline or placebo in a controlled setting where both groups are experiencing nicotine withdrawal.
Apathy, a profound loss of initiative and motivation, is often seen in older Veterans with memory problems. Apathy leads to serious health problems, increases dependency, and caregiver burden. If untreated, apathy hastens the progression to frank dementia. In a pilot study, the investigators found that apathy, working memory, and function can be restored using magnetic stimulation in some but not all older Veterans. The reason for this variation is unknown. The investigators propose a three-phase study in 125 older Veterans with mild memory problems. Their motivation, memory, and function will be measured periodically. Veterans with apathy that are eligible for treatment will receive either real or sham magnetic stimulation to the front part of their brain over 20 sessions. Genetic testing and biomarkers will be used to differentiate those who respond to magnetic stimulation from those who do not. Impact on function, quality of life, and rates of progression to dementia will also be studied. A project modification was obtained to conduct a cross-sectional study, the COVID Dementia study. The cross-sectional study will examine the effect of the pandemic on MCI and AD patients and their caregivers ("individual COVID-related factors" such as, personally infected, death of a friend/family member, economic hardship, disruption in care, isolation), barriers to telehealth, caregiver distress, NPS, cognition (including onset of delirium), and function. Our goal is to develop a multi-pronged, remotely deliverable intervention to address consequences of healthcare disruptions in older Veterans with cognitive impairment. Aim 1. To explore the association between COVID-related factors and neuropsychiatric symptoms in individuals with MCI and AD. Hypothesis: The number of COVID-related factors endorsed by caregivers will be positively correlated with the severity of NPI-Q in individuals with MCI and AD. Aim 2. To assess cognition (telephonic version of the Montreal Cognitive Assessment; tMoCA12, and daily function (Functional Activities Questionnaire; FAQ13). Hypothesis: The number of COVID-related factors will be positively correlated with the severity of cognitive and functional deficits in individuals with MCI and AD. Aim 3. To explore the associations among COVID-related factors and caregiver distress. Hypothesis: Caregiver resilience and perceived social support will modify the association between COVID-related factors and severity of distress in caregivers.
The goal of this clinical trial is to learn if vortioxetine improves mood symptoms and cognition in patients with early-stage behavioral variant Frontotemporal Dementia (bvFTD). The main questions this study aims to answer are: 1. Do individuals with mood symptoms and bvFTD have brain changes and cognitive profiles that differ compared to individuals without bvFTD? 2. Do mood symptoms and cognition improve following treatment with vortioxetine? Researchers will also determine whether there are changes in the brain associated with vortioxetine treatment. Participants will: * Undergo a screening visit that involves clinical assessments and laboratory tests * Undergo an initial brain magnetic resonance imaging (MRI) and fluorodeoxyglucose (18F) Positron Emission Tomography (FDG PET) scan before starting treatment with vortioxetine * Undergo memory and problem-solving tests before starting treatment with vortioxetine * Undergo approximately 12 weeks of treatment with vortioxetine, during which time there will be regular contact and assessments with the study psychiatrist * Undergo a repeat PET scan and repeat memory and problem-solving tests after 12 weeks of treatment with vortioxetine
This clinical trial is being conducted to see if brain stimulation and brain training together improves cognitive functioning and mood in older adults diagnosed with Mild Cognitive Impairment (MCI). Brain stimulation will be done using repetitive Transcranial Magnetic Stimulation (rTMS). Brain training will be done using immersive virtual reality cognitive training (iVCT) program. The goals of this clinical trail are as follows: * Examine if rTMS+iVCT intervention can improve and sustain objective cognitive functioning in individuals with MCI more than control or rTMS only groups * Examine if rTMS+iVCT intervention improves participants mental health symptoms, functional abilities, and quality of life more than control or rTMS only groups * Examine the impact of rTMS+iVCT intervention on caregiver burden. Eligible participants will be assigned to a standard treatment (no intervention control) group, rTMS only group of rTMS+iVCT group. All participants will undergo baseline assessment to evaluate their cognitive, emotional, and functional abilities. Those in the rTMS only group will receive rTMS treatments for five days per week for two weeks (total of ten sessions). Those in the rTMS+iVCT group will receive rTMS treatment followed by iVCT training for five days a week for two weeks (total of ten sessions). All participants will then repeat testing 2 weeks and three months after baseline testing to assess for possible treatment related changes and lasting effects.
Neuropsychiatric symptoms are the most difficult, distressing, and burdensome aspects of dementia care and a catalyst for long-term care placement. Intervention studies have largely focused on helping caregivers manage these symptoms. However, little has been done with regard to persons at the earliest stages of dementia, nor have persons with dementia played a direct and active, central role in helping to design intervention studies. This study focuses on building, pilot testing, and evaluating a tailored activity plan developed with persons with early-stage dementia. The goal of the intervention is to provide persons at this early stage meaningful activities and a plan for adaptation with disease progression.
Study will be conducted to determine if caregivers who use music at home will feel less burden and whether the person they are caring for will demonstrate decreased symptoms of dementia. Caregivers will participate in a series of psycho-educational trainings for six weeks. During this time, caregivers will learn how to use singing, music listening and music with movement with their family member. Caregivers should feel less stressed and a decreased sense of burden. The care recipient should appear happier with less occurrences of depression or restlessness.
The purpose of this research study is to learn whether it is possible and useful for caregivers to report behavioral or psychological symptoms of people with mild memory problems or Alzheimer's disease through a smartphone mobile application. The investigators believe that monitoring these symptoms and having a tool, like a mobile application, can provide quicker accessibility to the patient's clinical care team, which could improve care for patients and caregivers. These types of symptoms found in patients with mild memory problems or Alzheimer's disease are any type of psychiatric symptoms or abnormal behaviors one might develop as the result of these brain illnesses. Examples of psychological and behavioral symptoms are depression, anxiety, insomnia, irritability, agitation, and hallucinations. These symptoms differ from regular psychiatric symptoms, because they are caused by mild memory problems or Alzheimer's disease (AD). These symptoms can cause a lot of distress for patients and caregivers, and can lead to greater use of healthcare services.
This is a randomized, double-blinded, placebo-controlled, crossover trial that aims to 1) determine the efficacy of THC-free cannabidiol (CBD oil) in reducing the severity of agitation among participants and 2) determine whether THC-free CBD oil can reduce the burden on caregivers and increase the participants' quality of life.
Dementia is a disabling, progressive major neurocognitive disorder. Although cognitive symptoms drive the diagnosis of dementia, neuropsychiatric symptoms (NPS), such as depression, agitation/aggression, and psychosis, are common and associated with a number of significant adverse outcomes. There are currently extremely limited FDA (Food and Drug Administration)-approved treatments for NPS of dementia; there remains a critical need for safe and effective interventions for NPS that can be easily administered and monitored in typical clinical settings. As cognitive impairment progresses, persons living with dementia or cognitive impairment (PLWD/CI) increasingly rely on surrogate decision-makers, such that the quality of life for PLWD/CI is directly impacted by the decisions made by a surrogate. Discrepancy between preferences of PLWD/CI and proxy assessments by surrogate decision-makers is common. Our previous work has shown that such discrepancies in everyday preferences are associated with a higher burden of NPS for PLWD/CI. We hypothesize that discrepancy in everyday preferences assessment between PLWD/CI and care partners creates a set of "unmet needs" that increase the likelihood or severity of NPS; our preliminary data support this model of unmet needs as drivers of NPS. Specifically, as the neurodegenerative process disrupts the ability of PLWD/CI not only to provide for their own needs but also to communicate needs and preferences effectively to others, NPS may emerge in response. Thus, our hypothesis fits within a larger conceptual framework for understanding etiology of NPS: i.e., the mismatch between personality habits, physical/mental states, and environmental factors drive NPS as a means to resolve or communicate unmet needs. Building from this conceptual framework and our own preliminary data, the proposed pilot project addresses major gaps in the availability of safe, effective, and accessible strategies to reduce NPS by developing and testing the feasibility, acceptability, fidelity, and mechanistic target engagement of a templated, clinician-facilitated intervention to align everyday living preferences assessment between PLWD/CI and their care partners (n=20 dyads) to reduce NPS. The study is unique in developing a bioethics-driven intervention for NPS that is effective, portable, and easily transferrable to diverse settings. The crux of this intervention is meeting the needs of PLWD/CI by aligning everyday decision-making with priorities that matter most.
Alzheimer's disease (AD) is the most prevalent neurodegenerative disease of aging. Neuropsychiatric symptoms (NPS) in AD are a major cause of burden to patients, caregivers, and society and are near-universal at some point in the AD course. One of the most troubling of these symptoms is agitation (Agit-AD), typified by a variety of problem behaviors including combativeness, yelling, pacing, lack of cooperation with care, insomnia, and restlessness. There is a great need for better interventions that target Agit-AD, a major source of patient disability as well as caregiver burden and stress, particularly in the case of moderate to severe agitation. This pilot trial could open the door to "re-purposing" Dronabinol (Marinol®) as a novel and safe treatment for Agit-AD with significant public health impact.
Persons with dementia and their caregivers are often cared for in the community through home healthcare (HHC). While these patients and their caregivers need significant help and often have difficulty maintaining their quality of life, home healthcare clinicians are often unprepared to care for this population. This study will therefore examine the ability of an integrated, multi-pronged evidence-based practice intervention for home healthcare registered nurses, occupational therapists and physical therapists, the DSM-H, to improve the quality of care and quality of life for persons with dementia and their family caregiver. The investigators will enroll persons with dementia and their family caregiver upon admission to the HHC agency and examine their quality of life over 60 days following admission, comparing those who receive the intervention to those who serve as controls.
This is a four-site, randomized, parallel design, double-blind, placebo-controlled, 10-week trial of donepezil 10 mg daily for verbal memory problems among adults with TBI in the subacute or chronic recovery period. The study will recruit 160 persons with TBI and functionally important memory problems during a four-year period of open recruitment. The study aims are: 1. To evaluate the effects of treatment with donepezil on verbal memory as assessed by the Hopkins Verbal Learning Test-Revised Total Trial 1-3; 2. To evaluate the effects of treatment with donepezil on memory-related activities as measured by the Everyday Memory Questionnaire; 3. To evaluate the effects of donepezil on attention, processing speed, neuropsychiatric symptoms, community participation, quality of life, and caregiver experiences.
The Tailored Activity Program - Veterans Administration is a Phase III efficacy trial designed to reduce behavioral symptoms in Veterans with dementia living with their caregivers in the community. The study uses a randomized two group parallel design with 160 diverse Veterans and caregivers. The experimental group receives a transformative patient-centric intervention designed to reduce the burden of behavioral symptoms in Veterans with dementia. An occupational therapist conducts an assessment to identify a Veteran's preserved capabilities, deficit areas, previous roles, habits, and interests to develop activities tailored to the Veteran. Family caregivers are then trained to incorporate activities into daily care. The attention-control group receives bi-monthly telephone contact where education on topics relevant to dementia is provided to caregivers. Key outcomes include reduced frequency and severity of behavioral symptoms using the 12-item Neuropsychiatric Inventory (primary endpoint), reduced caregiver burden, enhanced skill acquisition, efficacy using activities, and time spent providing care at 4 months; and long-term effects (8 months) on the Veteran's quality of life and frequency and severity of behavioral symptoms, and caregiver use of activities. The programs' impact of Veterans Administration cost is also examined. Study precision will be increased through face-to-face research team trainings with procedural manuals and review of audio-taped interviews and intervention sessions.
The purpose of this study is to evaluate the safety and efficacy of citalopram for agitation in Alzheimer's dementia.
The goal of this research study is to learn more about the pain and/or other symptoms that patients may experience within five years from CRC diagnosis. Researchers also want to learn how genetic differences may affect the symptoms patients experience from cancer and cancer therapy.
The objectives of the study are to evaluate the safety, tolerability and efficacy of AVP-923 compared to placebo, for the treatment of symptoms of agitation in participants with Alzheimer's Disease (AD).