Clinical Trials

The purpose of this study is to identify potential biomarkers that may predict the development of Alzheimer's disease in people who carry an Alzheimer's mutation.

There is evidence that high blood pressure can cause changes in memory and thinking as people get older. When the SPRINT study intervention was stopped in September of 2015, important data on long term rate of Alzheimer’s, change in cognition, and impact on the kidneys were not able to be collected. Participants from the SPRINT study will undergo a single SPRINT ASK visit approximately two years after their SPRINT closeout visit to assess blood pressure, cognitive and kidney function.

To test the idea that solanezumab will slow the cognitive and functional decline of Alzheimer's Disease (AD) as compared with placebo in participants with mild AD.

The purpose of this study is to learn more about amyloid and tau burden in the brain of patients with Atypical Alzheimer's Disease and how that burden may change over a two-year period.

The investigators' goal is to determine if certain tests of memory and attention, performed while sleepiness is induced by a single dose of lorazepam, can predict whether or not an individual is at risk for developing Alzheimer's disease.

5.4 million Americans have Alzheimer's disease (AD) costing $185 billion annually, while 15 million caregivers look after these individuals. AD is the sixth leading cause of death, but the only one in the top 10 causes that cannot be prevented.

This study may demonstrate exercise in an amount attainable by many will be preventative in asymptomatic individuals including those with brain Abeta deposition already that are at impending risk of the disease. Sperling and colleagues(1) coined the research term AD-pathophysiological process (abbreviated AD-P) for use in studies such as the intervention in this proposal.

Our long term goal is to assess whether ...

The purpose of this study is to test whether an investigational drug called solanezumab can slow the progression of memory problems associated with brain amyloid (protein that forms plaques in the brains of people with Alzheimer Disease [AD]).

An urgent need exists to find effective treatments for Alzheimer's disease (AD) that can arrest or reverse the disease at its earliest stages. The emotional and financial burden of AD to patients, family members, and society is enormous, and is predicted to grow exponentially as the median population age increases. Current FDA-approved therapies are modestly effective at best. This study will examine a novel therapeutic approach using intranasal insulin (INI) that has shown promise in short-term clinical trials. If successful, information gained from the study has the potential to move INI forward rapidly as a therapy for AD. The study ...

Aging is associated with a loss of brain function and conditions such as dementia and Alzheimer's disease. It is likely that decreased brain metabolism is contributing to the progression of age related degenerative diseases. Aerobic exercise training can increase brain volumes and is associated with decreased risk for degenerative brain conditions. However, little is know about the changes that occur to brain metabolism with aerobic training and aging.

The purpose of this study is to determine whether Alzheimer's Disease related cognitive trajectories can be identified in midlife and disambiguated from normal aging using serial cognitive measurement.

Additionally, to determine the biofluid and imaging biomarker profiles associated with cognitive trajectories and with eventual conversion to dementia; to determine the effect of genetic characteristics on cognitive decline, biomarkers and disease and health status; to determine the influence of lifestyle and health features that confers risk and resilience to AD; to make data available to local, national and international researchers and to facilitate WRAP participation in linked studies including imaging ...

The primary objective is to evaluate the long-term safety and tolerability of aducanumab after a wash-out period imposed by discontinuation of feeder studies in participants who had previously received aducanumab (i.e., previously treated participants) or who had previously received placebo (i.e, treatment-naïve participants).

The study is designed to assess the demographic, clinical and imaging associations with the presence of microbleeds in atypical Alzheimer's disease. The primary hypothesis is that cognitive and functional performance will be poorer in atypical Alzheimer's subjects with microbleeds compared to those without microbleeds.

The purpose of this study is to evaluate the effectiveness of LY3314814 in the treatment of people who have mild Alzheimer's disease dementia.

The purpose of this study is to test whether two investigational drugs called CAD106 and CNP520, administered separately, can slow down the onset and progression of clinical symptoms associated with Alzheimer's disease (AD) in participants at the risk to develop clinical symptoms based on their age and genotype.

McLean hospital,  Mayo Clinic,  Emory University, LIJ/Northwell, and Pine Rest Mental Health are conducting a research study using Electroconvulsive therapy (ECT)  to treat agitation in dementia. ECT is a treatment done under general anesthesia, in which brief electric currents are passed through the brain to trigger a brief seizure. It is a safe and highly effective treatment for depression.

Agitation is common in nearly 60% of patients with dementia, increases caretaker burden, creates safety risk for individuals with dementia and others and increases risk for hospitalization and nursing home placement.

While ECT ...

The purpose of this study is to investigate how abrupt loss of ovarian hormones following bilateral oophorectomy affects overall aging, physical performance, and cognitive function, including the risk for Alzheimer’s disease in women who had this procedure performed prior to natural menopause for benign conditions.

The purpose of this research is to iteratively develop an natural language (NL) web-based app tool using information learned from stakeholders on design and content, especially as it relates to the needs and usability for persons with dementia and/or their caregivers.

The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) [ADCS-ADL-MCI].

The purpose of this study is to measure target engagement in cerebrospinal fluid (CSF) and blood, and to establish the feasibility and safety of Dasatinib plus Quercetin treatment in adults with early stage but symptomatic Alzheimer's Disease (AD) to inform and select the best blood, CSF, urine, and other analyses to conduct in banked samples from a larger Phase 2b clinical trial.

The purpose of this study is to identify lifestyle and health variable associated with abnormal cognitive aging and the development of Alzheimer's Disease (AD) and to use this information to develop interventions that will slow disease progressiong in asymptomatic persons. 

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 MK-8931 compared with placebo administered for 78 weeks in the treatment of Alzheimer's Disease (AD). The primary study hypotheses for Part I are that at least one MK-8931 dose is superior to placebo at 78 weeks of treatment with respect to change from Baseline in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score and that at least one MK-8931 dose is superior to placebo at 78 weeks of treatment with respect to change ...

The purposes of this study are to determine if neuroinflammation, as measured by PET imaging, is associated with Ab plaques in cognitively impaired vs. cognitively unimpaired participants, to determine if neuroinflammation, as measured by neuroinflammation PET imaging, is associated with the rate of cognitive in the 5 years preceding PET imaging, and to determine if neuroinflammation, as measured by PET imaging, is associated with plasma biomarkers of inflammation.

The purpose of this study is to evaluate whether treatment with JNJ-54861911 slows cognitive decline compared with placebo treatment, as measured by a composite cognitive measure, the Preclinical Alzheimer Cognitive Composite (PACC), in amyloid-positive participants who are asymptomatic at risk for developing Alzheimer's dementia.

The purpose of this study is to determine the effects of CNP520 on cognition, global clinical status, and underlying AD pathology, as well as the safety of CNP520, in people at risk for the onset of clinical symptoms of AD based on their age, APOE genotype and elevated amyloid.

The purpose of this study is to determine safety of plasma infusion in APOE 44 patients.
 

The primary purpose of this study is to evaluate acceptability of a combination compensation development and lifestyle modification program for brain health in those with subjective cognitive complaint without objective impairment measured by: a) the proportion of invited participants who chose to enroll; and b) quantitative and qualitative program satisfaction ratings.

The purpose of this study is to evaluate the safety and effectiveness of MABT5102A in patients who have mild to moderate Alzheimer's Disease.

This study aims to obtain EEG data on individuals at all stages of AD from preclinical through severe dementia.

The purpose of this study is to determine the effects of CNP520 on cognition, global clinical status, and underlying AD pathology, as well as the safety of CNP520, in people at risk for the onset of clinical symptoms of AD based on their age, APOE genotype and elevated amyloid.

The purpose of this study is to validate the Alzheimer Disease Biomarkers assays (Phospho-Tau/Total-Tau/Ab42) being implemented at Mayo to compare them to the referral tests in support of test validation efforts.

This randomized, placebo-controlled, double-blind, parallel-arm study will evaluate the safety and tolerability of at least two dose levels of intravenous (IV) crenezumab in 24-72 participants with mild to moderate Alzheimer disease (AD) (mini-mental state examination [MMSE] 18 to 28 points, inclusive). An optional open-label extension (OLE) will be offered after the completion of initial double-blind stage.

The purpose of this study is to evaluate the rate of cognitive change in clinically normal older individuals who "screen-failed" for the A4 trial on the basis of their screening PET imaging not demonstrating evidence of elevated amyloid accumulation ( were Aβ negative) but met all other A4 study eligibility criteria. While long term data suggests that older individuals with elevated Aβ burden are at increased risk of cognitive decline, it is important to demonstrate the different rate of clinical decline between Aβe ("Aβ elevated") and Aβne ("Aβ not elevated") individuals.  

The purpose of this study is to test whether two investigational drugs called CAD106 and CNP520, administered separately, can slow down the onset and progression of clinical symptoms associated with Alzheimer's disease (AD) in participants at the risk to develop clinical symptoms based on their age and genotype.

The primary objective of this application is to establish the feasibility of widespread clinical use of advanced MRS technology for early AD diagnosis in a strategic alliance between MR physicists at the UMN and physician scientists at Mayo Clinic.

The overall purpose of this research is to understand how ADAD develops in order to eventually provide treatments for this disorder. Each biological child of a person with an ADAD mutation has a 50% risk of inheriting the mutation, and thus of developing ADAD. This study will develop a registry of families with a known ADAD mutation and will collect, analyze and bank data, tissue, and brain images from the members who participate in the DIAN research study. The data and tissue collected are available to all qualified researchers who wish to determine what changes occur before and after ADAD ...

The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) [ADCS-ADL-MCI].

This study is designed to determine the effectiveness of florbetapir (18F) in changing patient management and to evaluate the association between scan status and cognitive decline.

The purpose of this study is to develop a large, well-characterized, biomarker-confirmed, trial-ready cohort to facilitate rapid enrollment into AD prevention trials utilizing the APT Webstudy and subsequent referral to in-clinic evaluation and biomarker confirmation. Participants with known biomarker status may have direct referral to the Trial-Ready Cohort. If you are interested in being selected for the TRC-PAD study, you should first enroll in the APT Webstudy (https://www.aptwebstudy.org/welcome).

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.

A brain PET scan is recognized as "reasonable and necessary" for some patients with "a recently established diagnosis of dementia" (Centers for Medicare and Medicaid Services, Decision Memo CAG-00088R, 2004), but evidence is less clear for patients having less severe cognitive problems. A substantial portion of such patients will develop Alzheimer's disease and other forms of dementia, which affect millions of people in the U.S., costing us over $100 billion annually. This project employs a prospective randomized protocol to determine whether PET scanning can help distinguish those patients with early Alzheimer's changes in their brains from those having other causes ...

The purpose of this study is to compare different ways of measuring tau both in the brain and in the blood over time in healthy controls and individuals with cognitive impairment. We will collect images in healthy elderly people, individuals with mild cognitive impairment and those diagnosed with Alzheimer’s disease to help us learn how the buildup of amyloid and tau proteins may contribute to developing the disease and in normal aging. Healthy young individuals will be used as controls.

This study is composed of 2 timepoints, separated by approximately 18 months. Each timepoint will require visits to the ...

The purpose of this study is to determine whether treatment with BAN2401 is superior to placebo on change from baseline of the Preclinical Alzheimer’s disease (AD) Cognitive Composite 5 (PACC5) at 216 weeks of treatment.

This study aims to establish, use, and extensively share a comprehensive longitudinal resource of genetic, non-genetic, and cognitive data, brain imaging and fluid biomarker measurements of amyloid-β (Aβ), tau pathophysiology, neurodegeneration, and inflammation (“A,T,N,I”), and biological samples to advance the study of cognitively unimpaired older adults at six levels of genetic risk for Alzheimer’s disease (AD) due to their apolipoprotein E (APOE) genotype, including understudied APOE2 and APOE4 homozygotes (HMs) at the lowest and highest risk and those APOE4 HMs and heterozygotes (HTs) who remain unimpaired at older ages due to unknown protective factors and spared pathophysiological effects ...

The purpose of this study is to examine the safety and effectiveness of suvorexant (MK-4305) to improve sleep in individuals who have Alzheimer's disease.

The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in subjects with early Alzheimer's disease (AD).

There is evidence that neurodegenerative changes precede clinical symptoms in Alzheimer’s disease by two decades (Villemagne et al, 2013). Early detection is critical for development of interventions to halt, slow, or even reverse these pathological processes. The promise of plasma biomarkers to identify early pathology is growing rapidly (Palmqvist et al, 2020), however it is likely that multiple converging biomarkers will be necessary to identify the earliest pathological changes, as subtle differences from healthy controls may fall within the margin of error for any given single biomarker measure. Here we propose that the evaluation of speech and language for both ...

The purpose of this study is to further characterize the serum and Cerebral Spinal Fluid (CSF) biomarker profile of idiopathic normal pressure hydrocephalus, both before and after VP shunt placement, and help differentiate this profile from Alzheimer’s disease.

The purpose of this study is to provide subjects who have completed participation in a Phase 2 or Phase 3 trial with TRx0237 continued access to therapy and to evaluate the long-term safety of TRx0237.

The purpose of this study is to explore the various retinal modalities to determine if they may provide a non-invasive method of identifying populations at risk for developing Alzheimer’s Disease (AD) and predict disease progression.

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 ...

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 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 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 study is designed to determine whether there are clinical features that can be used as biomarkers to predict whether underlying Alzheimer's pathology is the cause of a speech and language based dementia. The primary hypothesis is that the proportion of patients who test positive for beta-amyloid deposition will vary across different speech and language based dementias.

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

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.

This study is being done to collect skin samples from people with and without neurodegenerative and vascular disorders including Parkinson’s disease (PD), Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS), stroke and many others. We will use these skin samples to make and bank (store) a group of cells (cell line) called inducible pluripotent stem (iPS) cells.

The purpose of this study is to collect blood samples for DNA analysis from patients clinically diagnosed with Alzheimers disease, Lewy Body disease, and Frontotemporal degeneration.

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 ...

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 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 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 purpose of this study is to facilitate focus groups to assess/identify important qualities and characteristics that dementia caregivers are looking for in a supportive person, and to design a prototype website for matching current and former caregivers.

The purpose of this study is to develop and test the effectiveness of an investigational imaging technique called magnetic resonance elastography (MRE) to measure the stiffness (mechanical properties) of tissues.

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.

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 is an interview study to understand the views of people with the lived experience of 10 different genetic conditions on gene modification therapies, and specifically on prenatal gene editing. Prenatal gene editing is not happening now, but it is possible that prenatal gene editing will be available in the next few years, at least in a research setting, and we want to know your thoughts about the direction this technology is going. We to hope speak with many different stakeholders (patients and their families, clinicians, scientists) with diverse perspectives to understand values and priorities for prenatal gene ...

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 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.

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 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.

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.

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

The purpose of this study is to study the structure and biochemistry of the brain and/or bodily fluid and tissue after death.  Comparison of specimens from normal and diseased individuals provide essential clues that lead to a greater understanding of the diseased state which, in turn, will lead to new ideas for therapy.

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.