Clinical Trials

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 assess the safety and tolerability of CT1812 as a treatment for mild-to-moderate Dementia with Lewy Bodies.

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.

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.

Most individuals with rapid eye movement (REM) sleep behavior disorder (RBD) develop additional
neurological symptoms and are subsequently diagnosed with overt synucleinopathies, including dementia with
Lewy bodies (DLB), Parkinson disease (PD), and multiple system atrophy (MSA), indicating that RBD
represents a prodromal stage of synucleinopathy. RBD therefore offers a window of opportunity to intervene
with neuroprotective treatments at the earliest stages of disease when treatment is most likely to be effective.
Recognizing the importance of early intervention, key federal agencies focused on neurodegenerative disease
have proposed high priority recommendations for prodromal aspects of synucleinopathies, including
specifically RBD, to prepare for clinical trials. The North American Prodromal Synucleinopathy (NAPS)
Consortium began in 2018 to plan for neuroprotective clinical trials in RBD. The NAPS Consortium, currently at
10 sites, has thus far enrolled 215 participants with polysomnogram-confirmed RBD, and has successfully
performed comprehensive and standardized assessments and biofluids collection. The North American
Prodromal Synculeinopathy Consortium for RBD, Stage 2 (NAPS2) program represents an integrated
expansion of NAPS to support a longitudinal, prospective study of RBD, to address key gaps currently
prohibiting neuroprotective clinical trials in RBD. NAPS2 will establish enhanced infrastructure to support longterm
research in prodromal synucleinopathies.

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.

The purpose of this study is twofold:

Specific Aim 1

• In biopsies of skin from living subjects with DLB, PD without dementia (PD), and PD with dementia (PDD), assess the relative diagnostic sensitivity and specificity of IHC and seeding assay measures of aSyn, relative to normal control subjects.

Specific Aim 2

• In second biopsies of skin from subjects with DLB, PD and PDD, assess whether IHC and seeding measures of aSyn progress, regress or remain stable over time, indicating whether these may be useful as measures of therapeutic agent target engagement and disease progression.

Longitudinal Imaging Biomarkers of Disease Progression in Prodromal and Overt DLB

The objectives of this study are to determine the predictors of death within 6 months in individuals with Dementia with Lewy Bodies (DLB), to identify whether a change in caregiver measures can predict approaching end of life of individuals with DLB, and to identify factors that affect quality end of life experiences for persons with DLB and their caregivers.

Dementia with Lewy bodies (DLB) is part of Lewy body dementia, the 2nd-most-common degenerative dementia in the U.S. It is also one of the Alzheimer’s disease-related dementias (ADRDs). Evidence-based models of end-of-life care for ADRDs are insufficient; families face difficult medical decisions with little information for guidance. This is particularly relevant for DLB, where >70% of individuals die of the dementia itself or failure to thrive. Caregivers describe lack of knowledge of what to expect at the end of life as an important driver of negative end-of-life experiences. The proposed study addresses this unmet need. It also addresses the National Institute on Aging’s priority to improve quality of care and quality of life for persons with ADRDs at the end of life and their caregivers.