Clinical Trials

The purpose of the current research study is to understand how physiological measures, cognitive performance, and self-report of perceived stress change after acute stress and how different features of a relaxation room promote recovery after stress.

The goal of this project is to assess the validity and efficacy of online methods to predict and monitor cognitive and functional decline in elders with normal cognition (CN), subjective memory complaints (SMC), and mild cognitive impairment (MCI) using electronic versions of the Clinical Dementia Rating Scale (CDR) and the Financial Capacity Instrument-Short Form (FCI-SF). We will validate the e-instruments by implementing them within the Brain Health Registry (BHR, CHR #12-09628), and comparing online data obtained unsupervised at home with online data obtained while supervised in research clinics, over the telephone, or by video technology from participants followed longitudinally for 4 years ...

The purpose of this study is to better understand the link between insulin resistance and dementia. Earlier studies have shown that people with insulin resistance are two to four times more likely to develop Alzheimer’s disease and other dementias. Other studies have shown a link between the drug Metformin (the most widely used medication to treat prediabetes and type 2 diabetes) and a reduction in the development of dementia.

The aim of this study is to investigate if 40 weeks of Metformin treatment (in people 60+ years) enhances brain function and how brain function interacts with the ...

This study aims to provide clinical validation of EyeQuant, a fully automated retinal image analysis system for computation of vascular biomarkers indicative of cognitive disorders, using retinal fundus photographs collected from patients with mild cognitive impairment, Alzheimer’s disease, and vascular dementia. When deployed and commercialized, this system can assist in the identification of these biomarkers to aid in assessing drug/treatment efficacy and screening of the aging population in primary care practices and thus enable the early detection and effective management of patients with neurodegenerative disorders.

The purpose of this study is to assess the impact of sedation strategy on cognitive outcomes after left atrial appendage occlusion (LAAO) occlusion with the WATCHMAN FLX™ or AMULET device.

The purpose of this study is to examine the functional contributions of cerebral white matter (WM) tracts using stereo EEG electrical Stimulation mapping, to examine cognitive outcome in relation to the extent of mapped WM tract involvement in the surgical resection.

The purpose of this study is to develop real-time measurements of oculomotor and cognitive performance during Oculo-Cognitive Test (OCAT) to provide early signs of cognitive impairment due to cerebral hypoxia.

The purpose of this study is to develop a linguistically and culturally- appropriate adaptation of the memory support system (MSS) for Spanish-speaking Hispanics with subjective memory/cognitive complaints or a diagnosis of mild cognitive impairment (MCI) and their care partners in the U.S.

The purpose of this study is to reduce disparities in end-of-life care by increasing engagement in advance care planning among African Americans with mild cognitive impairment and early dementia and their caregivers.

The purpose of this study is to investigate whether giving transcranial direct current stimulation (tDCS) treatment using an investigational device called the Soterix tES Device (tDCS device) on the right side of the brain can improve performance on cognitive tests. Investigational means that the tDCS device is not approved by the U.S. Food and Drug Administration (FDA) for the use in this study.

To test the feasibility of conducting a 10-day Intermittent Theta Burst Stimulation (iTBS) repetitive Transcranial Magnetic Stimulation (rTMS) protocol twice using a cross-over design in individuals with Mild Cognitive Impairment (MCI), pilot test the study protocol to assess study design, and collect pilot data on the effect of stimulations over 3 different brain regions (left dorsolateral prefrontal cortex (DLPFC), lateral parietal cortex (LPC), vertex (control)) on working memory, new-learning and executive function in MCI. Neuropsychological and sleep measures, functional brain magnetic resonance imaging (fMRI), high density EEG and questionnaires will be performed at 5 timepoints – (i) baseline, (ii) post-treatment after first ...

The purpose of this study is to determine if the use of a distraction apron will decrease the length of hospital stay in patients with dementia or cognitive impairment.

The purpose of this study is to develop a program for individuals living alone with mild cognitive impairment (MCI).

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 ...

This study seeks to evaluate the efficacy and safety of ABBV-8E12 in subjects with Early Alzheimer's Disease.

The purpose of this study is to define the prevalence and impact of cognitive impairment and their impact on HRQOL in elderly patients with cirrhosis compared to elderly patients without cirrhosis.

The purpose of this study is to create this data repository as a mechanism to create a HABIT Registry that houses all retrospective and prospective HABIT-related data in a central database.

This study consists of two parts, Part I and Part II. The purpose of Part I of the study is to assess the efficacy and safety of verubecestat (MK-8931) compared with placebo administered for 104 weeks in the treatment of amnestic mild cognitive impairment (aMCI) due to Alzheimer's Disease (AD), also known as prodromal AD. Participants will be randomized to receive placebo, or 12 mg or 40 mg verubecestat, once daily. The primary study hypothesis for Part I is that at least one verubecestat dose is superior to placebo with respect to the change from baseline in the Clinical Dementia ...

The purpose of this study is to determine whether reduced genetic diversity as reflected in lower heterozygosity reduces our adaptability to stressors and thus influences human susceptibility to age-related cognitive decline and dementia.  This will be examined in an established cohort of individuals at genetically defined risk for Alzheimer’s disease based on APOE genotype who have been undergoing longitudinal neuropsychological assessment.

The purpose of this study is to evaluate the effect of neflamapimod on cognitive function as assessed in a study-specific Cogstate Neuropsychological Test Battery (NTB).

This study is being done to learn more about normal memory and aging, mild memory and thinking problems, Alzheimer's disease and other forms of dementia.

The purpose of this study is to measure subtle cognitive changes by using a simple and brief computer-based test (CogState Battery) in patients with Multiple Myeloma treated at Mayo Clinic in Scottsdale, Arizona.

This study is being done to learn more about specialized systems in the brain and how they relate to the disease processes in aMCI and AD.

The purpose of this trial is to assess the efficacy and safety of MK-8931 compared with placebo in the treatment of amnestic mild cognitive impairment (aMCI) due to Alzheimer's Disease (AD), also known as prodromal AD. Participants will be randomized to receive placebo, or 12 mg or 40 mg MK-8931, once daily. The primary study hypothesis is that at least one MK-8931 dose is superior to placebo with respect to the change from baseline in the Clinical Dementia Rating scale-Sum of Boxes (CDR-SB) score at 104 weeks.

The purpose of this study is to evaluate the effectiveness and safety of gantenerumab versus placebo in participants with early (prodromal to mild) Alzheimer's Disease (AD). All participants must show evidence of beta-amyloid pathology. Eligible participants will be randomized 1:1 to receive either subcutaneous (SC) injection of gantenerumab or placebo. The primary efficacy assessment will be performed at the end of the double blind period at week 104. Participants will then be offered to enter into an open-label extension (OLE). Participants not willing to go to the OLE will participate in a long term follow-up period for up to 50 weeks ...

The purpose of this study is to determine if there is a relationship between cognitive status and a patient’s ability to improve vocal quality through effective participation in voice therapy – including following directions within a session and compliance with a home exercise program, and carry-over into daily phonation.

The purpose of this study is to evaluate the effectiveness of a seven-day slow-tempo music intervention on the primary outcome of delirium/coma free days among mechanically ventilated, critically ill older adults.

Critically ill older adults admitted to the intensive care unit (ICU) are at a higher risk to develop delirium, which predisposes them to longer lengths of ICU and hospital stay, increased in-patient mortality, and higher risk of new acquired cognitive impairment and dementia. Music listening is a non-pharmacological intervention that holds potential to decrease ICU delirium.

The purpose of this Longitudinal Early-onset Alzheimer's Disease Study (LEADS) is designed to look at disease progression in individuals with early onset cognitive impairment . Clinical/cognitive, imaging, biomarker, and genetic characteristics will be assessed across three cohorts: (1) early onset Alzheimer's Disease (EOAD) participants, (2) early onset non-Alzheimer's Disease (EO-nonAD) participants,and (3) cognitively normal (CN) control participants.

The main goal of this study is to evaluate whether a certain set of memory and thinking tests that are in English also work in other languages after they are translated. The measures will test your memory, thinking, problem solving, and everyday function abilities.

To further investigate biomarkers in CSF as possible predictors for mild cognitive impairment and dementia

Automobile driving is a crucial aspect of everyday life, but driving safety problems including car crashes or speeding violations are a serious public health problem. Alzheimer’s Disease (AD) affects the ability to safely drive and raises crash risk. Mild cognitive impairment (MCI) raises the risk of dementia, and people with MCI have been shown to have problems with memory, decision making, and the ability to concentrate that could lead to unsafe driving, even before obvious dementia begins. Whether MCI patients who continue to drive are safe drivers or not is unknown.

The purpose of this study is to characterize and study the relationship of the clinical risk factors and predictors of seizures and epilepsy in patients with Early Onset Alzheimer's Disease (EOAD) using a 48-hour CAA-EEG.

This study is being done to learn more about normal memory and aging, mild memory and thinking problems, Alzheimer's disease and other forms of dementia. This study will help us determine how often memory problems occur in people in our community, and help to identify factors that may influence changes in memory and thinking skills.

The purpose of this study is to evaluate the impact of the BeWell360 coaching care model to improve functional and experience-related outcomes of informal caregivers (CGs) of patients living with mild cognitive impairment (MCI) due to Alzheimer’s Disease (AD) to create a foundational framework for future evaluation and implementation.

Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) has been realized in informing the design of therapeutic trials in AD. ADNI3 continues the previously funded ADNI-1, ADNI-GO, and ADNI-2 studies that have been combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer's disease (AD). The overall goal of the study is to continue to discover, optimize, standardize, and validate clinical trial measures and biomarkers used in AD research.

This study seeks to validate and further develop the NIH Toolbox for Assessment of Neurological and Behavioral Function® (NIHTB) for use in studies of cognitive aging beginning with normal cognition through progression into amnestic Mild Cognitive Impairment (aMCI) and into dementia of the Alzheimer’s Type, early stage (DAT).

The purpose of this study is to evaluate changes in CSF dynamics (e.g., velocity, flow rate) between patients with normal pressure hydrocephalus and healthy controls, as well as patients with other dementia disorders.

RATIONALE: Modafinil may help improve memory, attention, and fatigue caused by cancer treatment.

PURPOSE: This phase II randomized trial studies how well modafinil works in treating children with memory and attention problems caused by cancer treatment for a brain tumor.

This is a cross-sectional and longitudinal study that will evaluate imaging characteristics of 18F-AV-1451 in cognitively healthy volunteers, mild cognitive impairment (MCI) and Alzheimer's disease (AD) subjects.

The purpose of this study is to evaluate the feasibility of twice daily memantine started before radiation therapy (RT) and continued one month after radiation therapy (RT), and to evaluate the feasibility of twice daily (BID) memantine started before RT and continued 3 and 6 months after RT.

The objectives of this study are to demonstrate that patients with CNS hypersomnias exhibit cardiovascular and cognitive disturbances, and to demonstrate that CNS medications medications impact these cardiovascular and cognitive disturbances.

The intent of this research protocol is to test the equivalency of two amyloid imaging drugs (C11 Pittsburgh Compound B and F18 Flutemetamol). The investigators hypothesize that there will be no significant difference in the distribution of the agents to areas of amyloid deposition in the brain or to other normal brain structures. Recent data have shown similarity in the distribution of the drugs in subjects with AD or mild cognitive impairment (MCI). No comparison data of the two PET drugs in normal subjects has been published. It is important to understand differences in the images and biodistribution from the ...

The purpose of this study is to measure the frequency and severity of posttraumatic stress symptoms, depressive symptoms, anxiety symptoms, and cognitive impairment following dismissal from the ICU and three months later. This study also seeks to identify which of the multiple ICUs at Mayo Clinic yields the highest incidence of post-intensive care syndrome so that a future study designed to provide a therapeutic intervention can be implemented in those areas with the greatest potential.

The purpose of this study is to identify the association between untreated OSA and chronic insomnia and their association with cognitive decline, increased Alzheimer's Disease (AD) and vascular pathology.

The investigators propose using DaTscan in patients with 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.

The purpose of this study is to optimize profile questionnaire and matching algorithm developed in Phase I and implement in final website design, and to determine if algorithmically matched participants have statistically significant increase in match satisfaction and self-reported sense of resiliency and quality of life over randomly matched caregivers.

The goal of this study is to gain a better understanding of the status of advanced care planning among caregivers of patients with dementia and examine how this differs by race and disease stage.