Alzheimer Disease

Researchers are conducting the 100-Year Human Aging Study, an observational trial designed to follow participants over their lifespans to investigate which health measurements can predict mortality, serious diseases, and functional disability. The study aims to validate many longevity measures that currently lack prospective evidence by tracking physiological, cognitive, social, and environmental factors that change with aging. This research will generate important data to improve understanding of aging and longevity medicine. Participants undergo comprehensive multi-system clinical screenings including tests like cardiopulmonary exercise testing, body composition assessment by DEXA, echocardiography, electrocardiography, spirometry, neurocognitive testing, sensory assessments, metabolic testing, and detailed medical and social histories. The study allows for different levels of participation, from single tests to full two-visit screening batteries, and encourages repeat testing to capture health changes over time. During the study, participants receive individualized reports including investigational estimates of biological age and predicted cause of death. Researchers collect data on mortality, serious health events, chronic diseases, functional ability, and lifestyle changes through periodic follow-up over many years, potentially up to 100 years. This extensive data collection helps evaluate how well these measurements predict aging outcomes. All data are stored in raw form for future analysis and participants are supported with ongoing contact and opportunities for repeat assessments.

This research focuses on elderly patients hospitalized in Continuing and Rehabilitation Care Units (CRCU) who often suffer from neurodegenerative diseases and require personalized rehabilitation care. Many of these patients struggle with eating independently due to difficulty gripping standard cutlery, which may contribute to malnutrition. The study aims to evaluate the use of customized ergonomic cutlery handles designed with 3D printing technology to improve patients' autonomy during meals. Participants will receive cutlery handles with diameters tailored to their hand grip capacity, determined by a functional and joint assessment conducted by an occupational therapist. The handles come in sizes of 25, 30, 35, or 40 mm and are made from lightweight, thermoformable materials using 3D printing and computer-aided design. The study includes assessments at three lunch times: before using the adapted cutlery (Day 0), the first use of the adapted handles (Day 1), and after three days of use (Day 3) to observe learning and adaptation. During the study, the occupational therapist will assess the patient's autonomy in eating using the Katz scale and perform ecological assessments of meal interactions on Day 0 and Day 3 to observe compensatory movements. A dietician will measure the amount of food ingested at each lunch. The patient’s participation concludes after the Day 3 assessments, with outcomes focused on changes in food autonomy and upper limb compensation during eating.

Researchers are investigating the effects of deep brain stimulation (DBS) on brain function in patients with various neurological and psychiatric disorders, including Parkinson's disease, essential tremor, dystonia, depression, epilepsy, neuropathic pain, and Alzheimer's 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 paradigm's 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 Parkinson's disease (PD), multiple system atrophy (MSA), dementia with Lewy bodies (DLB), and Alzheimer's 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 method to detect the accumulation of a protein called TDP-43, which is linked to rare brain diseases like frontotemporal dementia (FTD) and amyotrophic lateral sclerosis (ALS). The study aims to see if the new PET tracer, called [18F]ACI-19626, is safe when injected and if it can reliably show abnormal TDP-43 in the brain. The study includes both healthy people and those suspected of having TDP-43 protein buildup to compare differences. The study involves up to 45 participants split into groups: healthy controls, symptomatic gene mutation carriers with FTD, and patients with other TDP-43 related diseases. Participants receive an intravenous injection of [18F]ACI-19626 followed by a PET scan to track the tracer's brain uptake. Some participants may have a second PET scan within a month to check if the results are consistent. The study lasts up to 3 months, including screening, scanning, and follow-up. During the study, participants will undergo physical and neurological exams, questionnaires, blood and urine tests, ECGs, and sometimes MRI scans to confirm eligibility and health status. After the PET scan, blood samples are taken, and participants receive a phone call 2 to 4 days later to monitor any side effects. The main measurements include safety assessments, brain uptake of the tracer, and how well the scans can quantify TDP-43. The study also evaluates radiation exposure and tracer consistency between scans.

Researchers are investigating the early brain regions involved in Alzheimer's disease and its precursors using novel molecular probes [18F]AV45 (Ab2) and [18F]AV1451 (Tau) with PET/CT imaging. This study aims to understand the distribution of positive brain lesions affecting mental state tests like the simple mental state examination and the Montreal Cognitive Assessment Scale in Alzheimer's patients. The goal is to provide molecular imaging information that may help study Alzheimer's disease mechanisms and establish objective diagnostic criteria for early detection. The study uses new imaging agents Ab2 and Tau PET/CT, which can detect pathological changes at the molecular level before symptoms appear. These molecular probes offer earlier and more visual detection of Alzheimer's disease-related changes, helping to define positive diagnostic criteria for early Alzheimer's disease. Participants include groups with mild cognitive impairment, Alzheimer's disease, and healthy volunteers. Participants will be assessed through PET/CT imaging using these molecular probes to observe brain pathology. Researchers will evaluate the diagnostic criteria for Ab2 and Tau imaging within two months. The study includes cognitive tests and clinical dementia rating scales. This observational study involves healthy volunteers and patients with mild cognitive impairment or Alzheimer's disease, aiming to improve early diagnosis through imaging techniques.

Researchers are evaluating the use of [18F]NIDF 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 Alzheimer's 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 [18F]NIDF. Following the injection, a PET/CT 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 Alzheimer's 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 PET/CT 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.

Researchers are evaluating the use of PET imaging with the radioligand [18F]PI-2620 to detect tau protein deposits in people with Alzheimer's disease and healthy controls. This open-label, multi-center, non-randomized Phase 3 study aims to compare PET imaging results during life with brain tissue analysis after death to better understand tau pathology in Alzheimer's. The study is sponsored by Lantheus Biosciences Ltd. and focuses on diagnostic accuracy and safety of this imaging technique. Participants receive an intravenous injection of [18F]PI-2620 at a dose of 185 MBq ± 20%. The study involves a PET scan procedure that participants must tolerate, including lying still in the scanner. There are no randomized groups or placebo controls as this is an open-label study. The research compares the PET imaging findings with post-mortem brain autopsy results to evaluate the ability of this imaging to detect tau deposits accurately. During the study, participants undergo PET imaging and are monitored for their ability to tolerate the scan. Brain donation consent is required for post-mortem histopathological comparison. Researchers assess the diagnostic performance of the PET scan in correctly identifying tau-related pathology and Alzheimer's disease changes. The primary outcome focuses on the accuracy of visual assessment of PET images compared to autopsy findings, with follow-up continuing until study completion and an average of one year after death.

Researchers are evaluating MK-2214, a study treatment designed to slow certain brain changes in people with early Alzheimer's disease (AD), a condition that causes memory loss, speech difficulties, and problems with decision-making. The study aims to find out if MK-2214 can slow the spread of tau protein in the brain compared to a placebo and to assess the treatment's safety and tolerability. Tau is a protein that builds up in AD and damages brain cells, impacting daily functioning. Participants will be randomly assigned to receive either MK-2214 or a placebo through intravenous (IV) infusions every 4 weeks during the study period. The study uses a quadruple-blind design, meaning that participants, care providers, researchers, and those assessing outcomes will not know which treatment is given. This phase 2 trial is planned to last up to approximately 23 months for treatment and assessment. During the study, participants will undergo brain scans including tau PET imaging and assessments of cognitive and daily living abilities at regular intervals. Researchers will monitor changes in tau protein levels, cognitive scores such as the Clinical Dementia Rating-Sum of Boxes (CDR-SB), and safety outcomes including adverse events and treatment discontinuations. The total study duration includes up to about 26 months of follow-up to evaluate safety and effectiveness.