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Dementia With Lewy Bodies clinical trials

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NCT ID: NCT06467461 Recruiting - Parkinson Disease Clinical Trials

Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM Sleep Behavior Disorder

Start date: February 8, 2024
Phase:
Study type: Observational

This project will test the hypotheses that people with 5-HT RBD have systemic alpha- synuclein pathology, prodromal DLB signs, and brainstem lesions in regions that control REM sleep. AIM 1 will seek to detect abnormally phosphorylated alpha- synuclein aggregates on targeted skin biopsy in a cohort of people with 5-HT RBD and matched controls (taking SSRIs but without RBD). Aim 2 will use ultra-high field MRI at 7T to examine the pontine region of the coeruleus/subcoeruleus complex for evidence of neurodegeneration as well as segment and parcellate REM sleep related neuronal structures. Aim 3 will test for speech deficits. While these aims are independent we suspect that the severity of autonomic, speech and cognitive deficits will correlate with loss of neuromelanin signal on MRI and pathology on skin biopsy. The investigation is a longitudinal designed study to examine histopathology, neuroimaging changes and speech function from baseline (Time 1) to a follow-up after 30 months (Time 2). A total of 60 individuals, 30 with 5-HT RBD and 30 controls, will be recruited at Time 1, brought back at Time 2, and tested across all Aims at both study visits.

NCT ID: NCT06445465 Active, not recruiting - Parkinson's Disease Clinical Trials

Study to Evaluate a Potential PET Radioligand for Imaging Alpha-synuclein Deposits in the Brain

Start date: December 24, 2020
Phase: Early Phase 1
Study type: Interventional

The overall goal of this protocol is to evaluate [18F]MNI-1216 (also known as [18F]ACI-12589) as an α-synuclein targeted radiopharmaceutical in 3 parts as follows: - Part 1: first in human (FiH) imaging - Optional Part 2: expansion of FiH imaging - Optional Part 3: retest imaging A total of up to 30 participants may be enrolled and participate in the study. Part 1 of the study will include up to 10 participants (target of up to 5 healthy volunteers and up to 5 participants with idiopathic Parkinson's Disease). There will be an ongoing review of study data in Part 1 to evaluate the characteristics of tracer binding and safety. If the study results are deemed adequate in Part 1, Part 2 and/or Part 3 may be initiated. The decision to initiate Part 3 may also include a review of data from Part 2, if Part 2 is performed and the data are available. If performed, Part 2 will include up to 20 participants, including health volunteers and participants with α-synucleinopathies to acquire additional tracer-related data. If performed, Part 3 will include up to 10 participants from in Part 1 and/or Part 2 (including health volunteers and participants with α-synucleinopathies) to evaluate the reliability of [18F]MNI-1216 ([18F]ACI-12589) Positron Emission Tomography (PET) imaging.

NCT ID: NCT06389032 Recruiting - Clinical trials for Dementia With Lewy Bodies

PERSEVERE: Peer Mentor Support and Caregiver Education in Lewy Body Dementia

Start date: May 13, 2024
Phase: N/A
Study type: Interventional

Lewy Body Dementia (LBD) is the second most common form of degenerative dementia, affecting at least 2.4 million US adults, and the overwhelming majority of persons living with LBD (PLBD) are cared for by family caregivers. LBD caregiver strain: 1) exceeds that of non-LBD dementia caregivers; 2) worsens caregiver physical and mental health; and 3) increases the risk of PLBD hospitalization and institutionalization. LBD progression is complicated by combined motor, cognitive, and neuropsychiatric decline, and is punctuated by falls, infections, dehydration, and neuropsychiatric symptoms leading to acute healthcare utilization. Although family caregivers are uniquely positioned to identify and manage these challenges, which may avert emergency department visits and reduce morbidity, many caregivers lack the knowledge, skills, confidence, resources, and support to do so. The study team aims to 1) quantify the impact of PERSEVERE on caregiver knowledge, attitudes, mastery, and strain; 2) identify the intervention and mentor factors determining implementation fidelity; and 3) test the effects of PERSEVERE on PLBD quality of life and healthcare utilization. This will be accomplished in an NIH Behavioral Model Stage II national, randomized, attention-controlled, 12-week trial of PERSEVERE in 502 LBD caregivers in partnership with the Lewy Body Dementia Association, Parkinson's Foundation, and LBD Caregiver Advisors. The study team will match intervention arm caregivers with a trained peer mentor who will coach them through a modular, theory-based curriculum on LBD knowledge and social support. Attention-control participants will receive weekly, curated links to educational materials. The study team will identify immediate and delayed intervention effects, including mediators of strain at 12 weeks, and caregiver strain and PLBD outcomes at nine months. Implementation fidelity and PLBD healthcare utilization will be tracked biweekly. Qualitative methods will explore the intervention- and mentor-specific factors predicting fidelity, mentee outcomes, and retention. Remote recruitment, mentoring, and community engagement strategies will maximize accessibility and inclusion of underrepresented caregiver groups. Results will illuminate the extent to which leveraging prior LBD caregivers as expert interventionists can improve current caregiver outcomes, and in turn, PLBD outcomes. These results will inform future adaptation and dissemination of this model for other conditions.

NCT ID: NCT06378372 Not yet recruiting - Dementia Clinical Trials

How Does Pianistic Musical Training Influence the Development of Alzheimer's Disease?

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn about and describe how pianistic training influences the development of Alzheimer's disease. The key question is: Can pianistic practice influence the development of Alzheimer's disease? Participants will receive piano lessons for 4 weeks (20 sessions) and we will evaluate the evolution of the different parameters described by the tests carried out.

NCT ID: NCT06357195 Not yet recruiting - Aging Clinical Trials

DIAMOND-Lewy Guidelines for Antipsychotic Use in Older Patients

Start date: May 30, 2024
Phase:
Study type: Observational

The goal of this observational study is to learn about current practices for the acute neuropsychiatric management of older adults during emergency department (ED) visits. Researchers will compare current standard of care practices with implemented guideline practice to see if standardized medication guidelines help reduce the usage of antipsychotics and/or benzodiazepines during acute presentations. The main questions this study aims to answer are: - How many older adults are receiving antipsychotics or benzodiazepines during emergency department visits? - Why are older adults receiving antipsychotics or benzodiazepines during emergency department visits? - How many older adults who receive antipsychotics or benzodiazepines during emergency department visits have an underlying cognitive or movement disorder? - What effects does administration of antipsychotics or benzodiazepines during emergency department visits have on patient outcomes in older adults and adults with neurocognitive disorders? - Does implementation of standardized medication guidelines help reduce the usage of antipsychotics and/or benzodiazepines during acute presentations?

NCT ID: NCT06354933 Completed - Alzheimer Disease Clinical Trials

Neurological Soft Signs in Neurodegenerative Dementias

DemeNSS
Start date: April 1, 2022
Phase:
Study type: Observational

The goal of this observational study is to investigate the prevalence of Neurological Soft Signs (NSS) in various categories of dementia patients compared to matched controls. The main questions it aims to answer are: - Does the prevalence of NSS significantly differ among patients with neurodegenerative dementias compared to controls? - Are NSS associated with neuropsychiatric alterations in dementia patients? - Do NSS correlate with cognitive screening tools? - Do NSS increase over time in patients with neurodegenerative dementias? Participants will undergo assessments including: - Evaluation of NSS using the Heidelberg scale - Neuropsychiatric assessments - Cognitive screening using the Mini-Mental State Examination (MMSE) and Frontal Assessment Battery (FAB) Researchers will compare dementia groups (Alzheimer's disease, Frontotemporal dementia, Corticobasal syndrome and Lewy body dementia) to controls to determine differences in NSS prevalence. Additionally, associations between NSS and neuropsychiatric symptoms, as well as cognitive performance, will be explored.

NCT ID: NCT06204575 Completed - Clinical trials for Dementia With Lewy Bodies

Focused Ultrasound Thalamotomy for Tremor Relief in Atypical Parkinsonism

FUSAP
Start date: November 1, 2013
Phase:
Study type: Observational

The goal of this retrospective observational study is to describe the efficacy of focused ultrasound ventral-intermediate nucleus thalamotomy in patients with atypical parkinsonism. - Is this treatment efficacious in patients with multiple system atrophy? - Is this treatment efficacious in patients with diffuse Lewy Body Dementia? Data will be collected from patients charts.

NCT ID: NCT06120049 Not yet recruiting - Parkinson Disease Clinical Trials

[18F]-MFBG Versus [123I]-MIBG and [18F]-PE2I in PD vs. MSA and DBL vs. AD

Start date: December 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Study goal: The goal of this prospective head to head comparison is to evaluate the effectiveness of [18F]-MFBG PET in assessing cardiac innervation, comparing it with [123I]-MIBG SPECT The study's primary focus is on distinguishing between Parkinson's disease (PD) and multiple system atrophy (MSA), as well as between dementia with Lewy bodies (DLB) and Alzheimer's disease (AD). Main questions: - Feasibility: How well can [18F]-MFBG PET detect changes in myocardial uptake in PD and DLB compared to the expected normal values in healthy individuals and AD and MSA-P patients? How well can it differentiate between these groups based on the detected changes? - Non-inferiority: Is [18F]-MFBG PET as accurate as [123I]-MIBG SPECT in distinguishing between PD and MSA-P, and between DLB and AD? Participant requirements: For the main study, participants will be required to visit the hospital for 3 or 4 appointments. During these visits, they will undergo a screening visit, MRI brain scan, a comprehensive neurological assessment, [18F]-PE2I PET, [123I]-MIBG SPECT, and [18F]-MFBG PET scans. Additionally, a separate dosimetry study will be conducted, involving healthy subjects who will visit the hospital for a screening visit and undergo [18F]-MFBG PET scans.

NCT ID: NCT06098612 Recruiting - Parkinson's Disease Clinical Trials

PET Imaging Evaluation of [11C]SY08

Start date: May 2024
Phase: Early Phase 1
Study type: Interventional

The overall goal of the proposed research is to evaluate the use of [11C]SY08 as a PET radiotracer for aggregated alpha synuclein (αS) in individuals with Parkinson's disease (PD), Multiple system atrophy (MSA), Dementia with Lewy Bodies (DLB) and healthy controls. The purpose of this study is to evaluate the use of [11C]SY08 as a PET radiotracer for αS fibrils in individuals with PD, MSA, DLB and healthy controls. The specific aims of the current study are: 1. To determine brain uptake, distribution, and kinetics of [11C]SY08 in healthy individuals. 2. To determine brain uptake, distribution, and kinetics of [11C]SY08 in patients with alpha synuclein aggregates in the brain, including PD, DLB and MSA. 3. To determine human dosimetry of [11C]SY08 in healthy individuals An intravenous bolus injection of [11C]SY08 will be administered per subject for brain PET imaging.

NCT ID: NCT06005935 Recruiting - Clinical trials for Dementia With Lewy Bodies

Environmental and Reproductive Health Risk for Lewy Body Dementia

LBD-TOROS
Start date: August 1, 2023
Phase:
Study type: Observational

The goal of this survey study is to identify environmental, occupational and reproductive health risk factors for Lewy body dementia, which includes Parkinson's disease dementia and dementia with Lewy bodies. Participants will complete a one-time survey online or over the phone that includes questions on environmental, occupational factors they may have been exposed to and on medical history including reproductive health. Researchers will then compare the responses of people with Lewy body dementia and people without Parkinson's or memory/thinking problems to see which factors play a role in Lewy body dementia. Identifying risk factors can guide future treatment efforts and provide more insight to this dementia.