About 380 males and females aged 55 to 90 years with psychosis associated with Alzheimer's disease will take part in this worldwide study. This study will be conducted at up to 100 sites in the United States, Canada, France, Germany, Spain and others in approximately 10 countries. The study will test KarXT, a combination of 2 study drugs, xanomeline tartrate and trospium chloride. Xanomeline tartrate stimulates the muscarinic receptors (a receptor in the nervous system) that is involved in cognitive and neurobehavioral functions. Stimulation of these receptors has been shown to effect changes in cognitive performance and promote antipsychotic activity. Trospium chloride is a muscarinic inhibitor that is expected to reduce the negative peripheral (outside the brain) muscarinic side effects of xanomeline tartrate without reducing its intended therapeutic effects in the brain.
The goal of this study is to assess whether KarXT helps in relapse prevention in people with psychosis associated with AD as compared to placebo, see how safe and well accepted KarXT is in people with psychosis associated with AD as compared to placebo, and check what the body does to KarXT and how long does it stay in the body (pharmacokinetics) as compared to placebo.
This is a Phase II research study to determine dosing of non-invasive brain stimulation for patients with Mild Cognitive Impairment (MCI) and depression. The brain stimulation treatment used in this study is called repetitive transcranial magnetic stimulation (rTMS). rTMS is a Food and Drug Administration (FDA)-approved treatment for depression. The goal of the study is to see if brain stimulation can be used for MCI patients to improve memory, thinking, and mood, and what dose of stimulation works best.
The study uses a form of rTMS called intermittent theta burst rTMS (accelerated iTBS). This treatment has not been FDA-approved for MCI patients. This double-blind study requires 11 study visits over the course of six months.
The purpose of this research study is to help us better understand if a Program of SUPPORT-D Intervention may be helpful to persons diagnosed with Alzheimer's or a Mild Cognitive Impairment and their caregivers. The 6-week SUPPORT-D program provides educational information for both the Caregiver and Person with Alzheimer's or a Mild Cognitive Impairment to assist with planning as the disease progresses.
Volunteers for this study will be asked to complete some questionnaires, review written information bi-weekly for 6 weeks with a nurse via telehealth. Volunteers will be asked to track how often written information is reviewed during the 6-week study period. There will be 5 telehealth visits over 8 weeks, each visit will be about 45-60 minutes.
The purpose of the Alzheimer's Disease Registry Study (ADRS) is to (1) create a registry that will continue to provide study-ready subjects who meet research diagnostic criteria for the different stages of AD and who have been evaluated using research instruments that allow for their participation in clinical trial research, (2) provide a platform to allow for continual follow-up with registry participants to allow for their participation in clinical trial research at different stages of the disease process, and (3) to incorporate a population of veterans and minorities suffering from AD, a population that is not proportionally represented in clinical trial research, into the registry.
By collecting data pertaining to medical history, current medication details, family history, vital signs, and memory/thinking symptom concerns and evaluating a subject's ability to perform certain tasks, such as memory and thinking tests, questions about their daily activities, and social functioning; researchers are able to determine a research subject's potential eligibility in a clinical trial research protocol.
A registry with such information would enable researchers to effectively and efficiently identify potentially eligible research subjects for the program's evolving portfolio of Alzheimer's disease-related clinical trials.
The purpose of the study is to see if daily use of nicotine patches will slow or reverse memory loss in participants with Mild cognitive impairment, an early stage of mental decline associated with Alzheimer's disease. Nicotine may mimic natural chemicals in the brain that play a crucial role in memory function, and previous studies have shown that nicotine may improve attention, learning, and memory. In this study, participants will receive either nicotine (up to 21mg/day, the standard dosage of a nicotine patch) or placebo for 2 years to see if these improvements in brain function can be observed over a longer period.
Neurological diseases are the leading cause of disability worldwide and a major contributor to health problems in children and adults. As the majority of these conditions result in lifelong disabilities, the implications for the family and for society is significant.
A significant number of adult and childhood neurological diseases have a genetic component and are caused by changes in our DNA and/or RNA leading to functional changes in the central nervous system. However, for many patients afflicted with these disorders, traditional genetic testing does not identify a clear genetic cause. The goal of this study will be to use newer genetic techniques to evaluate patients and families with neurological disorders to better understand the genetic basis of the disease.
Alzheimer's disease and Epilepsy may affect over 80% of individuals that have Down syndrome by the age of 60. Biomarkers found in the blood can enhance our understanding of the earliest changes linked to disease and may enhance clinical detection and healthy aging for individuals with Down syndrome.
The purpose of this study is to discover early neurobiological processes underlying the transition from healthy aging to disease. Our research team has developed technology that allows detection of small changes in the brain that get transferred to the blood.
We are recruiting individuals that either have or do not have Down syndrome for this biomarker study. Participants should be between the ages of 6 months and 85 years old and may include mothers and siblings of a child with Down syndrome. Infants and children will require consent form a parental or legal guardian.
Each participant will provide a blood sample for research purposes. We will also gather some basic health information about senses, habits, exercise level and smoking/vaping exposures.
Patients with Alzheimer Disease and patients with Heart failure (and a control group free from both the previous mentioned conditions) will be evaluated with cardiac and neuropsychological assessments, in order to investigate the relationship between the two conditions. The study consists of two initial visits, and a 4- and 8-year follow-up visit.
The purpose of this study is to use neuroimaging to understand how networks in the brain change over time. Although the single most significant risk factor for developing Alzheimer's disease (AD) is age, the neurobiological processes underlying the transition from normal aging to AD are not well understood. Our group of researchers has developed ways to use MRI to detect small changes in certain parts of the brain. We will use neuroimaging to understand how the connections in the brain change over time in healthy aging. The goal is to discover which brain changes are present in healthy aging.
Participants will have two study visits (about 2 years apart) where they will undergo tests to assess mental function, fill out questionnaires, and undergo a blood draw, brain MRI and PET scan and provide a saliva sample. At the second visit, participants will not repeat PET scan. Participants will continue to be followed longitudinally every two years as long as the study is funded.
Participants are required to have a Co-Participant accompany them for the first portion of each visit. This individual must be a reliable informant that has contact with the participant at least once per week.
This study will use neuroimaging to understand how the connections in the brain change in Alzheimer's Disease. Changes will also be examined in individuals with mild cognitive impairment and healthy aging. The goal is to discover which brain changes are present in healthy aging and MCI so that future studies can assess the risk for developing Alzheimer's Disease. The study involves blood draw, cognitive testing, MRI, PET scanning, and a 1-year follow-up visit to repeat cognitive testing and MRI scanning.