Lewy Body Dementia

The 100-Year Human Aging Study is a long-term observational research project enrolling adult participants to undergo detailed multi-system health screenings and follow them throughout their lives until death. The study aims to identify which health measurements taken at enrollment and repeatedly over time can predict overall mortality, cause-specific death, serious diseases, and functional disability. It addresses the current lack of validated longevity measures by generating data on how various physiological and cognitive functions relate to aging outcomes. Participants undergo a comprehensive clinical screening that includes tests of cardiorespiratory fitness, strength, mobility, neurocognitive performance, sensory functions, and metabolic health. Structural imaging assessments like DEXA scans, echocardiography, electrocardiography, spirometry, retinal photography, and vascular ultrasound are performed. Laboratory tests and detailed medical, social, and environmental histories are also collected. The study allows participation from single tests up to a full two-visit screening, with repeat testing encouraged to track health changes over time. Throughout the study, participants receive individualized reports with investigational estimates of biological age and predicted mortality risks, which are being evaluated against actual health outcomes. Researchers collect data continuously on mortality, disease occurrence, disability, and health behavior changes. The study involves ongoing follow-up with periodic assessments and aims to preserve all collected data for future analyses, with participant involvement potentially spanning their entire lifespan.

Researchers are evaluating the optimization of 18F-DOPA PETCT imaging in specific patient groups including pediatric patients with congenital hyperinsulinism or neuroblastoma, pediatric and adult patients with neuroendocrine tumors or brain tumors, and adults suspected of Parkinsons disease or Lewy body dementia. The study aims to improve image quality using a new digital PETCT scanner and intravenous furosemide, while also exploring gallbladder activity patterns related to dopaminergic degeneration. Participants will receive an intravenous injection of 18F-DOPA, with some also receiving a single intravenous dose of furosemide. The study includes a primary objective of assessing image quality improvements in the pelvis area and a secondary objective examining gallbladder activity patterns using dynamic imaging in a subgroup. Imaging data will be compared to previous scans with older technology. During the study, participants will undergo PETCT scans, with measurements of lesion size and activity, bladder activity, and image artifact scoring. A questionnaire will screen for gallbladder disease history. The research team will analyze the imaging results and gallbladder activity patterns, with follow-up assessments occurring within one to three months. The total planned enrollment is 800 patients over approximately five years, with detailed monitoring of image optimization and gallbladder activity.

This research focuses on elderly patients hospitalized in Continuing and Rehabilitation Care Units, many of whom suffer from neurodegenerative diseases and need personalized rehabilitation care. The study evaluates the use of ergonomic cutlery handles tailored to patients hand grip ability, aiming to improve their autonomy during meals and potentially reduce malnutrition risks. These custom handles are made using 3D printing technology, offering a lightweight and inexpensive alternative to standard adapted cutlery. Participants will start with a functional and joint assessment of their hand to determine the optimal diameter for the cutlery handles 25, 30, 35, or 40 mm. Their autonomy in eating and the amount of food consumed will be measured at three lunch times before using the adapted handles Day 0, the first lunch using the handles Day 1, and after three days of use Day 3. Ergotherapists will also assess upper limb compensations during meals without and with the technical aid. Throughout the study, participants autonomy in eating is evaluated using the Katz scale, with additional assessments by ergotherapists and dieticians. The study tracks changes in food intake and physical compensations over three days, ending after the Day 3 assessments. The main outcome measured is patients food autonomy at Day 1, with secondary outcomes including autonomy and food intake at Day 3 and upper limb compensations. Participation lasts only through the initial assessment and the three-day intervention period.

Researchers are investigating the effects of deep brain stimulation DBS on brain function in patients with various neurological and psychiatric disorders, including Parkinsons disease, essential tremor, dystonia, depression, epilepsy, neuropathic pain, and Alzheimers disease. This prospective cohort study aims to use advanced MRI techniques, particularly functional MRI fMRI, to better understand how DBS influences brain circuits and to explore whether fMRI can aid clinical practice in managing DBS therapy. Participants in this study include patients who will undergo or have already undergone DBS electrode placement. The study involves performing structural MRI scans using 1.5 Tesla or 3 Tesla machines as well as resting state and task-based fMRI scans. DBS patients will be scanned while their devices are programmed at different stimulation settings, including switched off and switched on states. The fMRI results will be shared with clinicians to help guide DBS programming decisions. During the study, participants will have multiple brain scans from three months before DBS implantation to one year after. Researchers will assess brain areas activated by DBS, examine structural and functional brain connectivity through MRI, and monitor clinical outcomes. The study includes regular evaluations to observe how DBS impacts brain function over time, aiming to improve post-operative follow-up and optimize treatment for these patients.

Cognitive impairment related to dementia is often missed in primary care, especially among older adults from minority and socio-economically disadvantaged populations. Researchers are evaluating the 5-Cog brief cognitive assessment, a quick, simple, and standardized tool that takes less than 5 minutes and addresses cultural and logistical barriers. This pragmatic cluster-randomized trial aims to test whether the 5-Cog paradigm improves detection of new cases of cognitive impairment and dementia care in older adults with cognitive concerns. The study involves 22 primary care clinics in Bronx and Indiana, enrolling about 6,600 patients aged 65 and older who report cognitive concerns. Participants receive either the 5-Cog battery combined with a clinical decision-making tool or enhanced usual care, which includes cognitive concern screening. The 5-Cog battery includes tests like Picture Memory Impairment Screen, Motoric Cognitive Risk Syndrome diagnosis, and Symbol Match. Primary care physicians receive results and decision support but use their clinical judgment in care decisions. Participants undergo cognitive concern screening before their appointments. Researchers will review new cognitive impairment diagnoses and improvements in dementia care within 90 days after the primary care visit using electronic medical records. Additional evaluations include tests for reversible causes, medication changes, specialist referrals, and social support. The study also examines the 5-Cog paradigms implementation and cost-effectiveness, focusing on populations facing health disparities. Total participation duration varies by patient and clinic schedule.

Researchers are evaluating the use of 18F-MFBG PET scans to assess heart nerve activity in people with Parkinsons disease PD, multiple system atrophy MSA, dementia with Lewy bodies DLB, and Alzheimers disease AD. The study compares this method with the current standard 123I-MIBG SPECT scans, focusing on distinguishing between PD and MSA as well as DLB and AD. This is a prospective study conducted at two centers, aiming to validate the accuracy and feasibility of 18F-MFBG PET for these neurological conditions. Participants will undergo several imaging tests including dynamic cardiac 18F-MFBG PET, 123I-MIBG SPECT, and cerebral 18F-PE2I PET scans. Healthy volunteers and patients with confirmed diagnoses will be included, with groups divided by age and disease duration. A dosimetry study will also be conducted for healthy volunteers to measure radiation exposure from 18F-MFBG. Multiple visits to the hospital are required for scans and assessments. During the study, participants will have thorough neurological assessments, brain MRI scans, and blood sampling alongside PET and SPECT imaging. Researchers will evaluate diagnostic accuracy, effect size of tracer uptake changes, and relationships between heart nerve imaging and brain dopamine transporter changes and autonomic dysfunction. The study includes monitoring for safety and will analyze regional heart uptake patterns. Participants can expect 3 to 4 hospital visits with detailed imaging and clinical evaluations over the study period.

Researchers are evaluating a new imaging agent called 18FACI-15916 to safely and reliably measure the buildup of a protein called alpha-synuclein in the brain. This protein is involved in conditions like Parkinsons disease, Lewy body dementia, and Multiple System Atrophy, collectively known as alpha-synucleinopathies. The study includes both healthy volunteers and people with suspected alpha-synuclein-related diseases to compare protein levels and assess safety and detection accuracy. The study is an open-label, early-phase PET microdose trial involving up to 46 participants divided into four parts. Participants will receive an intravenous injection of 18FACI-15916 followed by a PET scan to detect alpha-synuclein deposits. Some will have a second PET scan to test measurement reliability, while others will undergo a whole-body PET-CT scan to estimate radiation dosage. The study includes a screening phase, scanning visits, optional spinal fluid collection, and follow-up safety calls. Participants will visit the clinic for consent, eligibility assessments including physical exams, neurological exams, questionnaires, blood and urine tests, ECG, and in some cases MRI and PET scans with a licensed tracer. During the PET scan, blood samples will be collected, and some may provide spinal fluid. Safety is monitored through follow-up phone calls. The total study duration ranges from 10 to 14 weeks depending on the part of the study the participant is in. Researchers will measure brain uptake of the tracer, adverse events, vital signs, and the reproducibility of PET scan results.

Alpha-synucleinopathies are age-related neurodegenerative disorders characterized by the build-up of alpha-synuclein in nerve cells, leading to conditions like Parkinsons disease, Multiple System Atrophy, and Dementia with Lewy Bodies. Pure Autonomic Failure is a related condition affecting the peripheral autonomic nervous system and may signal risk for developing central nervous system synucleinopathies. Researchers aim to identify biomarkers, especially changes in dopamine production in key brain areas, to predict progression from peripheral to central disease. Participants receive a radiolabeled drug called 18FF-DOPA, which is used in PET scans to study dopamine activity in the brain. Before the PET scan, patients take oral doses of carbidopa and entacapone to enhance imaging quality by reducing peripheral metabolism of 18FF-DOPA. The PET scan involves a slow injection of 18FF-DOPA followed by about 95 minutes of serial brain imaging to observe dopamine-related changes. During the study, participants undergo clinical exams to confirm diagnosis and receive the PET imaging procedure. Researchers measure differences in 18FF-DOPA uptake across patient groups 95 minutes after imaging starts to assess dopamine function. The study includes patients with autonomic failure, possible synucleinopathies, and healthy adults aged 18 and older. The study is designed to monitor safety and gather detailed imaging data over the scan period.

Researchers are evaluating the use of 18FNIDF PET imaging to visualize abnormal tau protein pathology in the brains of living humans. This technique targets tau neurofibrillary tangles, which are linked to neurodegenerative diseases such as Alzheimers and other tauopathies. The study focuses on assessing the safety and diagnostic effectiveness of this imaging agent, which may offer advantages over existing tau PET tracers due to its stronger binding and lower off-target effects. Participants will receive a single intravenous injection of approximately 10 b1 3 mCi of 18FNIDF. Following the injection, a PETCT scan will be performed to capture images showing the distribution of the tracer in the brain. The study includes both healthy volunteers and patients with cognitive impairment or probable Alzheimers disease. There is only one main study period involving this single injection and imaging session. During the study, participants will be monitored for safety from the time of injection up to seven days afterward. The primary assessments include safety evaluation and measuring how the tracer spreads in the body during the PETCT scan on the injection day. Researchers will also evaluate the diagnostic performance of the imaging over a two-week period from enrollment to the end of imaging. Participants involvement is limited to the injection, scanning, and follow-up safety checks.

The GENESIS clinical study aims to map HLA genetic variation in the Greek population and evaluate possible correlations with selected underlying diseases. It is a multicenter, prospective, non-interventional clinical study targeting 12,000 subjects over an anticipated duration of 36 months, with the goal of creating a pilot HLA map for medical research and possible clinical applications. Each subject will complete one visit at a participating site and provide demographic information, including date of birth, gender, race, ancestry, height, and weight, as well as information about smoking or vaping, alcohol consumption, arterial blood pressure, diagnosed diseases, and current treatments. Recent clinical laboratory results from up to 12 months before sample collection may also be collected when available, including blood count, metabolic, liver enzyme, and biochemical parameters. Two buccal swabs will be collected from each subject for DNA extraction and HLA genotyping analysis. Selected DNA samples will also undergo low-pass whole genome sequencing to further investigate associations between the HLA region and autoimmune diseases. After the analysis is completed, an individualized ancestry report will be securely available to study subjects if they elect to access it.