11 Clinical Trials for Various Conditions
Dementia illness often co-exists with painful medical conditions associated with aging (e.g., degenerative joint disease, osteoarthritis, skin ulcers, back pain, headaches, cancer, or angina). While the standard practice is pain assessment for all patients, the elderly with dementia have special needs for assessment, management, and evaluation. When they are unable to verbalize pain, objective measurement of their discomfort are possible manifestations of pain. No research relates systemic pain treatment with reduction of negative problematic behaviors in patient dementia.
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.
The study evaluates the effects of Prazosin on agitation in adults with Alzheimer's disease. Two thirds of the participants will participate in the medication portion, while one third will participate in the placebo portion
Over 5 million Americans have Alzheimer's disease or a related dementia, a progressive and irreversible neurodegenerative condition, affecting also close to 15 million family caregivers (CG). A hallmark of the disease and one of the most significant challenges in dementia care is neuropsychiatric symptoms (NPS) of which agitation is the most disabling and frequently occurring. It is associated with increased health care costs, reduced life quality, heightened caregiver burden, disease acceleration and nursing home placement. Treatment typically involves pharmacologic agents; however, these are at best modestly effective, carry serious risks including mortality, and may not reduce family distress. Recently issued position statements from medical organizations suggest nonpharmacologic strategies as first-line treatment. Nevertheless, nonpharmacological strategies for agitation remain understudied. We propose a Phase III efficacy trial to test a novel 8-session patient-centric intervention, the Tailored Activity Program. We will test the program using a randomized two-group parallel design of 250 people with dementia (PwD) and their CGs (dyads) who will be randomly assigned to received a program of tailored activities or a control intervention of equivalent in-home attention and social contact. The trial assesses PwDs' preserved capabilities, deficits, previous roles, habits, interests and home environment from which activities are developed to match PwD profiles. Families are trained to implement activities and modify them for future decline. Our primary study aim evaluates the effect of tailored activities at 3 months on agitation (Hypothesis: PwD in the tailored activity program will have less frequent agitation compared to the control intervention condition. Three secondary aims evaluate: 1) 6-month effects of tailored activities on agitation and quality of life in PwD (Hypothesis: PwD receiving tailored activities will manifest lower severity scores at 6 months and better quality of life compared to PwD in the control intervention); 2) Immediate effects of tailored activities at 3 and 6 months on CG wellbeing, and time spent providing care (Hypothesis: CGs receiving training in tailoring activities will report enhanced wellbeing and less time caregiving compared to the control intervention (3 and 6 months); and 3) Cost effectiveness of the Tailored Activity Program expressed as an incremental cost outcome achieved in the form of CG burden reductions and willingness to pay for burden reductions (3 and 6 months; Hypothesis: Tailoring activities will be cost effective compared to the control intervention at each test occasion). Exploratory aims will evaluate treatment effects on psychotropic medication use and other troublesome behaviors, if effects differ by cognitive status, if CGs receiving the tailored activity program will use activities at 6 months and with what frequency, how time gained is spent, and if frequency/duration of treatment and activity use affects outcomes. If proven efficacious and cost effective, the Tailored Activity Program has potential to transform clinical practice by offering a proven nonpharmacologic treatment for agitation of PwDs at home. This trial addresses a critical clinical need and public health priority identified by recent legislative activity.
A study of outpatient participants with Alzheimer's disease or a related dementia who have difficult behaviors that are upsetting for them or their caregivers. Prazosin is a medication that is commonly used to treat people with high blood pressure. Research with prazosin has shown that it may be effective in treating behavioral problems by reducing excess adrenalin effects in the brain.
The purpose of this study is to examine the efficacy of non-pharmacological ways to treat agitated behaviors in nursing home residents with dementia. The hypothesis is that non-pharmacological interventions will be more effective than placebo in decreasing such behaviors.
The primary objective of the study is to assess the relative efficacy of Depakote ER and Seroquel for agitated behaviors among veterans with a dementia diagnosis residing in a Department of Veterans Affairs (VA) nursing home care unit (NHCU). The secondary objective of the study is to assess the relative tolerability of Depakote ER and Seroquel in this population. The primary hypothesis is that agitated dementia patients will demonstrate a significantly greater reduction in Cohen-Mansfield Agitation Inventory (CMAI) scores while treated with Depakote ER compared to treatment with Seroquel.
This study is aimed at investigating specific pharmacological interventions in the treatment of the disruptive, agitated behavior associated with Alzheimer's patients. In addition, it is hoped that specific clinical profiles will be found to predict which treatment is most effective for these particular patients.
The purpose of this research study is to test if adding one infusion of mesenchymal stem cells to the current treatment with antipsychotic medication may help control behavioral problems in people with a diagnosis of moderate to severe Alzheimer's disease.
The Healthy Patterns Study intervention is a home-based activity intervention designed to improve symptoms of circadian rhythm disorders (CRD) and quality of life (QOL) in home-dwelling persons with dementia. We will use a randomized two-group parallel design of 200 people with dementia and their caregivers assigned to intervention or attention control groups.
The goal of this study is to assess the benefits of Healing Touch, an energy based therapy on post-operative discomfort and the rate of recovery in children. The aims of this study are to measure the effect of Healing Touch on post-operative: 1) anxiety, 2) emergence agitation/ emergence delirium (EAD), 3) pain, 4) time to wake-up, 5) time to meet PACU's departure criteria, 6.) maladaptive behaviors 2 weeks following surgery \& 7)readmissions for complications 2 weeks following surgery. This is a triple blinded randomized controlled trial with three parallel groups. 240 subjects, ages 3 or 4 will be randomly assigned to receive the usual post-operative care, the usual care plus a post-operative Healing Touch treatment, or the usual post-operative care plus a sham Healing Touch treatment done by an untrained research assistant. The participants \& parents, the evaluators, and the principle investigator will be blinded to study group assignment.