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297 active trials for Mild Cognitive Impairment

Tau PET in Imaging and Cognition: Healthy Adults From 55-90

The investigators aim to use the new PET radioligand, 18F-MK-6240, to detect tau pathology in cognitive healthy and mild cognitive impairment (MCI) elders. The investigators will then examine the interactions between differential tau burden and performance on cognitive tasks, functional magnetic resonance imaging (fMRI) neural activation patterns, and other cognitive and behavioral measures. By investigating these relationships, the investigators hope to understand the cognitive and behavioral outcomes of tau deposition found in specific brain regions in cognitively normal/mildly cognitively impaired adults. Furthermore, the study aims to examine how the presence of tau may contribute to the risk of subsequent cognitive decline, neurodegeneration, and dementia.

Start: June 2018

Autoimmune Features of Neurodegenerative Disorders

This study is being conducted to better understand the role of inflammation in Parkinson's disease (PD) and Alzheimer's disease (AD). The investigators plan to recruit 30 PD, 30 AD/Amnestic Mild Cognitive Impairment (aMCI), and 60 age matched healthy controls in this study to study the role of immune response in PD and AD. The study involves up to two study visits involving brief questionnaires and blood draw of up to 250cc (approximately 17 tablespoons) to be collected. More ways to participate, including 1) smaller amount blood donation (up to 100cc per visit for 1-2 visits); and 2) participation via tele-visit and mobile phlebotomy visits (blood donation up to 50cc, ~5 tubes, by a certified mobile phlebotomist at home/location of choice) now available.

Start: May 2019

Effects of a Multimodal Intervention on Persons With Mild Cognitive Impairment

This is a randomized controlled trial of an empowerment-based 13-week multimodal intervention to improve neuropsychiatric symptoms, cognitive functions, and health-related quality of life among persons with mild cognitive impairment

Start: September 2020

Spanish Translation and Cultural Adaptation of the Memory Support System

This study seeks to translate a proven cognitive treatment for Spanish-speaking Hispanics with subjective memory/cognitive complaints or a diagnosis of mild cognitive impairment (MCI) and their care partners. MCI causes cognitive changes that are noticed by the individual or others. These changes do not significantly interfere with independence. MCI also increases the risk of developing Alzheimer's or another dementia, particularly in Hispanics/Latinos. There is no medication that improves cognition or delays MCI. However, providing cognitive treatment can alleviate the effects of MCI. Only a few cognitive interventions have been proven effective in the U.S., but none has been adapted to the Spanish-speaking Hispanic community. Our proposed cognitive treatment uses effective strategies (e.g., calendar and notetaking) to compensate for memory loss. The investigators will first follow international guidelines to ensure proper translation of our treatment into Spanish. Then, the investigators will pilot test our translated intervention in 20 Spanish-speaking Hispanic participants with subjective memory/cognitive complaints or a diagnosis of MCI and their care partners (40 participants total). The investigators will also assess the degree to which participants follow medical advice; their beliefs in their ability to succeed in and do daily activities, including managing medications; their feelings and potential burden associated with caregiving before and after the treatment as well as 8 weeks later. Results will allow the investigators to determine whether our treatment was effective and to calculate the number of participants required for larger studies. Overall, the study represents an important step to respond to the needs of the Hispanic community.

Start: March 2019

The Active Mind Trial: An Adaptive Randomized Trial to Improve Function and Delay Dementia

Older adults at risk for dementia show a variety of cognitive deficits, which can be ameliorated by different cognitive training (CT) exercises. The best combination of CT exercises is unknown. The aim is to discover the most efficacious combination of CT exercises as compared to cognitive stimulation (which will serve as a stringent, active control) to modify the functional trajectories of older adults' with MCI, who are at high risk for dementia. The primary objective of the U01 phase is to design and pilot-test an adaptive, randomized clinical trial (RCT) of cognitive training (CT) combinations aimed to enhance performance of instrumental activities of daily living (IADL) among persons with mild cognitive impairment (MCI). The longitudinal endpoint goal is reducing incident dementia. The primary aim of the study is to determine which CT combination has the best probability to delay dementia by producing the largest IADL improvements. The study further aims to explore neuroimaging and novel blood-based biomarkers.

Start: March 2020

Efficacy of a Multicomponent Cognitive Intervention in Adults With Subjective Cognitive Decline and Mild Cognitive Impairments

Individuals with mild cognitive impairment (MCI) and subjective cognitive decline (SCD) have greater risk of developing dementia. Cognitive intervention is a topic of great interest in individuals with MCI and SCD for the purpose of preventing or delaying the occurrence of dementia. There are many different types of cognitive interventions, which aim to positively impact the cognitive functioning of an individual and have been classified as cognitive stimulation, cognitive training, and cognitive rehabilitation. However, most studies used neuropsychological cognitive measures for outcome evaluation. The impact of cognitive interventions on daily functional performance among individuals with MCI and SCD were rarely explored. In addition, cognitive training focusing on specific cognitive outcomes is suspected to have limited far transfer to everyday measures. Therefore, a multicomponent intervention which integrates several types of intervention is recommended to reach the maximum impact on daily function. The purposes of this study are to examine the effects of a multicomponent cognitive intervention on cognitive and daily functional outcomes in individuals with MCI and SCD, and to compare the effects between the two groups. In addition, the investigators will also investigate whether the demographic (e.g., age and educational level, etc.) and clinical variables (e.g., duration of cognitive complains, level of depression and baseline cognitive function, etc.) may affect the outcomes of cognitive intervention.

Start: January 2019

Safety and Immunogenicity of Repeated Doses of ABvac40 in Patients With a-MCI or Vm-AD

Alzheimer's disease (AD) is the most common type of dementia, accounting for 50-75% of the estimated 47 million people with dementia worldwide. The amyloid cascade hypothesis of AD proposes that amyloid-? (A?) peptide accumulation in the brain, caused by an imbalance between A? production and clearance, is the initiating factor of a cascade ultimately leading to dementia. A? peptides are generated from sequential cleavage of the amyloid precursor protein (APP), including A?40 and A?42. A?40 is the predominant variant (90%) among the secreted A? forms and although A?42 is more hydrophobic and prone to aggregate, and A?42 oligomers are regarded to be the most neurotoxic species, A?40 can also produce highly toxic diffusible aggregates, which can be prevented in vitro by specific anti-A?40 antibodies. Several studies have proposed that a high concentration of A?40 in the brain distinguishes patients with AD from those who have senile plaques but are cognitively normal, pointing to the importance of A?40 in the onset of dementia. In keeping with this, previous studies have demonstrated that specific anti-A?40 antibodies label NFTs in the entorhinal cortex and the hippocampus of AD brains, and that these do not co-localize with tau NFTs, suggesting the presence of degenerating neuronal populations filled with C-terminal fragments of A?x-40. In addition, A?40 is the main component of amyloid deposition around cerebral arteries causing cerebral amyloid angiopathy (CAA), which has a prevalence of about 80-90% in patients with AD (for more information see Lacosta et al. Alzheimer's Research & Therapy (2018) 10:12 DOI 10.1186/s13195-018-0340-8). Considering those previous results suggesting that strategies targeting A?40 could represent novel disease-modifying therapies, we have developed ABvac40, the first active vaccine targeting the C-terminal end of the A?40 peptide. The purpose of this Phase II study is to confirm in patients with a-MCI or vm-AD the level of safety and tolerability obtained in the ABvac40 Phase I clinical trial in patients with mm-AD. In addition, the study is aimed to better characterize the immune response elicited by ABvac40 and to explore its effects on AD biomarkers.

Start: February 2018

Contributions of mTBI to Neurodegeneration Due to Chronic Traumatic Encephalopathy (CTE) and Alzheimer's Disease (AD)

This is a research study that aims to examine whether Veterans with mild Traumatic Brain Injuries are at risk for dementia by studying their memory, brain wave activity, brain structure and proteins that can be elevated after brain injury and in dementia.

Start: July 2021

Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance

Loss of slow wave sleep (SWS) is common in mild cognitive impairment (MCI) and Alzheimer's disease, and is thought to worsen thinking, memory and brain degeneration. Initial studies suggest that correction of sleep deterioration may slow the progression of brain damage in mild cognitive impairment, and might be able to stop the development of Alzheimer's disease. Transcranial alternating current stimulation (tACS) uses electrodes to deliver very small amounts of electricity through the brain, with direct effects on brain cell function. Transcranial electric stimulation has been demonstrated to enhance slow wave sleep and to improve memory when applied during sleep in healthy adults. The purpose of this research is to investigate tACS to modulate sleep, thinking/memory, mood, and quality of life among normal healthy adults, older adults, as well as individuals with MCI.

Start: March 2018

Lithium As a Treatment to Prevent Impairment of Cognition in Elders

Alzheimer's disease (AD) is the most common cause of dementia in adults 65 years and older. AD leads to a complete loss of memory and independent function, and presently there is no cure. Many studies suggest that lithium treatment may delay dementia onset or slow its progression. However, more research is needed to understand the extent of its anti-dementia properties if it will be deployed broadly in the general population. This study will examine whether lithium has anti-dementia properties in older adults who have mild cognitive impairment and are at risk of becoming demented.

Start: September 2017

Effect of Nutritional Supplementation With Turmeric on the Cognitive Performance of Subjects With Metabolic Syndrome

The EPICURO study aims to demonstrate the beneficial effects of a 6-month dietary supplementation with an improved bioavailable turmeric (MERIVA®) on inflammatory, oxidative and metabolic parameters together with cognitive performance, potentially resulting in the reduction of the risk of cognitive decline in subjects, male and female, with Metabolic Syndrome. The results obtained will provide novel insights on MERIVA® for improving the prevention of age-related cognitive decline and Alzheimer's disease.

Start: February 2021

Light, Metabolic Syndrome and Alzheimer's Disease

To test the long term effect of a light treatment on cognition, sleep and metabolism in patients with Mild cognitive impairment (MCI) or mild Alzheimer's disease or related dementia (ADRD).

Start: April 2019

Home-Based CR and tDCS to Enhance Cognition in Persons With Mild Cognitive Impairment and Late Life Depression

The overall goals of this project are to assess the feasibility and impact of designing and implementing an at-home intervention aimed at preventing long-term cognitive decline and improving cognition in individuals currently at-risk for developing AD.

Start: October 2016

Interventions to Attenuate Cognitive Decline: Keys to Staying Sharp

Different cognitive intervention approaches have been developed to attenuate decline (e.g., cognitive engagement, training, or stimulation), but it is not clear which approaches are efficacious. It is also not clear when, along the continuum of normal cognitive aging to mild cognitive impairment (MCI-a transitional stage before dementia onset), it is most efficacious to intervene. This randomized clinical trial will determine the efficacy of a novel cognitive engagement intervention approach (music training) as compared to cognitive stimulation (which will serve as a stringent, active control). Grounded in theory, the central hypothesis is that interventions enhancing central auditory processing (CAP), a strong, longitudinal predictor of MCI and dementia, will improve cognition. Music training is increasingly recognized as a feasible means to attenuate age-related cognitive decline. Prior research and preliminary data suggest that intense piano training enhances CAP and is likely more effective than cognitive stimulation. Correlational studies indicate superior CAP, executive function, and other cognitive abilities for adults with formal music training compared to non-musicians. The specific aims of the study are to examine the efficacy of music training relative to cognitive stimulation (active controls) to improve CAP, cognition, and everyday function among older adults with and without MCI. The efficacy of music training will be established and moderating effects of MCI status will be examined. The proposed study further aims to elucidate the underlying mechanisms of effective cognitive intervention approaches by exploring mediators of training gains. The proposed study is the first phase II randomized trial of music training to enhance older adults' cognition. Mediation analyses will elucidate the underlying mechanisms of intervention effects.

Start: January 2018

New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study

New IDEAS is an observational, open-label, longitudinal cohort study designed to address the requirements of the CED provisions of the NCD on beta-amyloid PET. Building on the initial Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) study, New IDEAS will evaluate the association between amyloid PET and patient-centered outcomes in an expanded and more ethnoracially and clinically diverse group of Medicare participants presenting with cognitive impairment.

Start: December 2020

Filipino Multicomponent Intervention to Maintain Cognitive Performance in High Risk Population (FINOMAIN)

FINOMAIN is a community-based, cluster randomized controlled trial (cRCT) of dance intervention INDAK and standardized vascular care. The study aims to develop and assess the effectiveness of a cost-effective and culturally - fit intervention for Filipino older adults at high risk for developing dementia. The first objective of the study is to evaluate the efficacy of dance intervention INDAK on cognitive function as assessed by the Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog), Mnemonic Similarity Task (MST), and Executive Function Composite (EFC) among older adults with mild cognitive impairment (MCI). To increase the sensitivity of primary outcome for various composites of cognition, aside from ADAS-Cog that assesses core cognitive deficits of dementia, investigators will develop an executive function composite that will combine measures of executive control using performance outcomes on tests including Trail Making Test (TMT), Digit Symbol Substitution Test (DSST), Verbal Fluency Test (VFT), and Number Cancellation Task (NCT). Executive function composite scores have been used to track aging populations at risk for dementia and are shown to be sensitive in capturing cerebrovascular benefits and used as instruments in studies with similar non-pharmacological intervention (i.e. aerobic exercise, dance). Additionally, the investigators will add MST which is a measure for episodic memory, memory representations and pattern discrimination which are all cognitive domains highly correlated with hippocampal function. The second objective of the study is to determine the effect of dance on neuroplasticity as measured by brain volumetry and functional connectivity demonstrated through Magnetic Resonance Imaging (MRI) and change in other behavioral and functional outcomes of participants with MCI.

Start: May 2019

The Effectiveness of Dual Task Training in Elderly With Cognitive Decline

Cognitive decline is the impairment of memory, execution, or language. Early detection of the individuals who manifest cognitive decline and provide appropriate interventions may help reduce the burden of their caregivers and the medical expenses of the health-care system. Many studies have found that dual-task training combining cognitive training and exercise can improve cognitive function in older adults. However, it is yet not clear the appropriate frequency of the effective dual-task training for elderly with cognitive decline. Thus, this study aims to compare the intervention effects of high frequency sequential and low frequency dual-task training for elderly with cognitive decline.

Start: September 2020

Evaluation of Cognitive State in Senior Subjects Using Neurosteer EEG System

This is an observational study. Patients who fulfill all inclusion criteria and none of the exclusion criteria will be enrolled in the study, be neurologically evaluated and will go through EEG recordings while listening to an auditory cognitive assessment tool and preforming tasks. EEG recordings will be analyzed using proprietary computational analyses.

Start: October 2020

Real-time fMRI Neurofeedback in Patients With MCI

Increased activity in the hippocampus (i.e., hyperactivity) during a fMRI memory task was found in patients with Mild Cognitive Impairment due to Alzheimer's disease (MCI). Those with increased hippocampal activity exhibited elevated clinical progression. Reducing hippocampal hyperactivity with pharmacological treatment reduced hyperactivity and improved memory performance. The investigators of this study will test whether real-time fMRI neurofeedback will also downregulate hippocampal activity and thereby improve memory performance.

Start: July 2020

A Novel Computer-Based Functional Skills Assessment and Training Program

People with cognitive impairments such as Mild Cognitive Impairment (MCI), often experience difficulty performing everyday routine activities. Further, normative age-related changes in cognition often lead to deficits on previously learned skills and impede new learning such as learning of new technology systems. This is of great concern, given population aging, the increasing number of older adults with cognitive impairments, and the continual deployment of new technologies in everyday contexts. The objectives of this SBIR Phase II study is to build on a previous Phase I SBIR project and refine and further evaluate a novel integrated computer-based functional skills assessment and training (CFSAT) program that provides training on everyday tasks critical to independent living (e.g., financial and medication management) with non-impaired older adults (NC) and adults with MCI.

Start: April 2021