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Dementia clinical trials

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NCT ID: NCT04405596 Not yet recruiting - Lewy Body Disease Clinical Trials

Ambroxol as a Novel Disease Modifying Treatment for Lewy Body Dementia

Start date: January 2025
Phase: Phase 1/Phase 2
Study type: Interventional

This is a randomized, placebo-controlled, double-blind study investigating whether the medication Ambroxol is safe,effectiveness and well tolerated for the treatment of Lewy Body Dementia (LBD). Currently the main treatments for patients with LBD target symptom management. However, none of the medications treat the underlying cause of the disease, which includes the accumulation of protein in the brain. Therefore, even if patients respond well to symptomatic treatment, they continue to deteriorate. Therefore, the purpose of the current study is to make sure Ambroxol is safe to take long term and to test the effects of Ambroxol in treating the cognitive impairments associated with LBD by modifying the underlying causes of the disease. There will be a total of 15 people participating this this study, which will last 52 weeks. Over the study period patients will undergo clinical, neuropsychological and neuroimaging assessment to assess changes.

NCT ID: NCT04334200 Not yet recruiting - Dementia Clinical Trials

The Development and Evaluation of a Culturally Tailored Support Group Program on the Psychosocial Wellbeing of Family Caregivers of Individuals Living With Dementia in Hong Kong

Start date: July 1, 2020
Phase: N/A
Study type: Interventional

Hong Kong is also facing the increasing prevalence of dementia. Evidence states that dementia caregivers have poor psychosocial wellbeing including stress, depression and anxiety. Effective services and interventions should be provided to the caregivers to improve their psychosocial wellbeing. Recent studies suggest that cultural adapted intervention is necessary. Such intervention can support caregivers to improve psychosocial wellbeing by using the culture and rituals to relevant racial caregivers creatively. Among all interventions for dementia caregivers, it was reported that the support group/program was more effective to improve psychosocial well-being of dementia caregivers. However, the studies about support group for dementia caregivers did not report the cultural sensitivity elements explicitly. Most of them mention the component 'language' only. Other elements, including philosophical thoughts, had not been mentioned in the articles. It is necessary to provide more cultural components including philosophical thoughts in the support groups. Moreover, the studies did not report on the benefits of adding cultural elements in the interventions to dementia caregivers. Although the literature mentioned cultural adapted interventions were beneficial, the research on understanding its benefits is inadequate. More caregiver intervention studies to understand the advantages of cultural tailoring are needed. Hence, we need to do more studies to understand the benefits of adding cultural elements in the interventions to caregivers. A research is performed to develop and evaluate a culturally adapted intervention for dementia caregivers to improve their psychosocial wellbeing. This research study is to evaluate the effectiveness and benefits of culturally tailored interventions for caregivers of older adults with dementia on improving psychosocial well-being. Mixed method and quasi-experimental design will be applied. There are 2 groups: intervention and control groups. Each group needs to complete pre and post-test to assess their psychosocial well-beings. The pre and post-test data will be used for assessing the effectiveness of the culturally tailored intervention program for the dementia caregivers. For intervention group, qualitative data, i.e. data from focus group interview will be performed to assess the benefits of inclusion of cultural elements in the program.

NCT ID: NCT04321889 Not yet recruiting - Stroke Clinical Trials

Efficacy of Defurocumarinized Bergamot in the Treatment of Agitation in Severe Dementia Patients.

BEO
Start date: April 1, 2020
Phase: N/A
Study type: Interventional

This study evaluates the efficacy of defurocumarinized bergamot in the treatment of agitation in severe dementia patients. Bergamot essential oil (BEO), able to modulate the endogenous, peripheral and central opioid system involved in painful states, has developed in models of inflammatory pain and neuropathic pain; it is also effective when administered by inhalation. Participants in the study will be divided into 2 parallel groups, one treatment group and one placebo, to evaluate the clinical efficacy of defurocumarinized bergamot loaded in a nanotechnological system of essential oil release in the pharmaceutical form of a cream in the treatment of agitation, in in Over-sixty-five-year-old patients of both sexes diagnosed with severe dementia.

NCT ID: NCT04293263 Not yet recruiting - Dementia Clinical Trials

The Effect of Shared Listening to Personalized Music on Symptoms of Behavioral Disorders in the Elderly With Advanced Dementia

Start date: April 1, 2020
Phase: N/A
Study type: Interventional

This study is of great importance because it uses a method that has not been tested in the past. To date, various interventions have been examined that use music for patients with dementia. At the same time, no intervention was conducted that integrates an additional person who shares personalized music with the patient. If the combination of another person who shares the positive effect of the music with the patient is found to enhance the positive effect of the music, it can change the routine of work with dementia patients and may even reduce the use of tranquilizers among them. In many cases, it has been found that one of the biggest challenges for family members who treat patients with dementia is the lack of content in the sessions and as a result, the growing sense of alienation between the patient and his family. Listening to music can be a significant tool in the hands of the family, the main caregiver, the medical staff, and any person who comes in contact with the patient, a tool that can strengthen the sense of connection and connection between them.

NCT ID: NCT04262973 Not yet recruiting - Dementia Clinical Trials

Interprofessional Education and Collaborative Practice Model for Dementia in Acute Care

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to develop an interprofessional education and practice model for acute care related to dementia and evaluate its effectiveness of implementation.

NCT ID: NCT04248270 Not yet recruiting - Dementia Clinical Trials

A Noval Tau Tracer in Young Onset Dementia

Start date: February 20, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Dementia is a clinical syndrome which characterized by progressive cognitive impairment, behavior disturbance and dysfunction of daily activity. In aging population, Alzheimer's dementia (AD) is the most common late onset dementia which occupied about 50-75%, the vascular dementia, frontotemporal lobardegeneration (FTLD) and corticobasal syndrome is followed. On the other hand, the young onset dementia (YOD), which represents the onset of dementia before65 years old, is only about 1/10 to 1/100 proportion of late onset dementia. The YOD is different from late onset dementia in the proportion of degenerative subtype (e.g. the FTLD is more frequent than AD). Besides, frequent atypical presentation of clinical syndrome in the YOD which characterize the different variant of AD made the early accurate diagnosis of AD is more difficult. Currently, there is no available data to describe the proportion of subtype in YOD in Taiwan. In AD dementia, two important biomarkers are amylod plaque made by ß-amyloid protein and neurofibrillary tangle made by phosphorylation tau protein. In the past, they only can be seen under the microscope findings at autopsy study. Recently, the new amyloid tracer and tau tracer had been developed and could evaluate the deposition of amyloid and tau protein in human brain. These progresses had substantially improved the accurate diagnosis of degenerative dementia. A noval tau tracer [ 18F]PM-PBB3, which had substantially improved the off-target binding and more clear background in human brain than previous tau tracer. In current project, investigator will aim to consecutive collect 50 YOD due to the neurodegeneration in 3 years using the NIA-AA research framework system(ATN system) to achieve accurate diagnosis of the dementia subtype by the detail clinical neurology study, neuropsychological examination, amyloid positron emission tomography (PET) and tau PET study. In the first year, investigator will perform feasibility study to explore the topographical tau distribution in different subtype of YOD. In the next 2 years, investigator will perform a large scale study in a group of YOD to understand the amyloid and tau deposition and their association with clinical parameters. From current project, investigator could understand the tau deposition in different YOD subtype. Investigator also could understand the correlation between clinical phenotype and molecular pathology. Investigator will use a mathematic model to construct the model of diffusion kurtosis imaging from brain magnetic resonance imaging (MRI) and relate the white matter integrity with amyloid and tau PET imaging.

NCT ID: NCT04168021 Not yet recruiting - Dementia Clinical Trials

Remote Ischemic Conditioning of the Human Brain in Dementia Patients

RICBDE
Start date: January 1, 2020
Phase: N/A
Study type: Interventional

The study investigates the incidence of remote ischemic conditioning in mild cognitive impairment and dementia patients

NCT ID: NCT04154254 Not yet recruiting - Dementia Clinical Trials

Applying PET/MR for Dementia Applications

Start date: January 10, 2020
Phase: N/A
Study type: Interventional

Dementia is a common disorder affecting about 50 million people worldwide with nearly 10 million cases every year . It is characterized by cognitive impairments as well as behavior disabilities. Cognitive impairments include difficulties with memory, attention, language and other higher cortical functions. Behavior disabilities may include apathy, aggressive behavior, hallucinations and changes in social interaction. The most common cause of dementia is Alzheimer disease (AD). To plan a proper treatment for the patient it is critical to evaluate accurately the type of dementia as well as obtain the earliest diagnosis possible. However, accurate differential diagnosis in dementia poses difficulties due overlapping phenotypes and limited understanding of the mechanism and pathologies . Diagnosis of the dementia is performed based on the combination of clinical symptoms and biomarkers that include imaging, genetic biomarkers, cerebrospinal fluid (CSF), and other objective markers of disease . The two main modalities used for dementia imaging are Magnetic Resonance Imaging (MRI) and molecular imaging including Single Photon Emission Tomography (SPECT) and Positron Emission Tomography (PET). MRI is performed with various of contrasts such as high resolution T1- weighted, T2- weighted and Diffusion Tensor Imaging (DTI) and functional MRI (fMRI) [2]. These methods give information about morphological modifications in the brain and atrophy characterizing the specific dementia type. In addition brain perfusion and diffusion pattern and assessment of the changing un the resting state functional connectivity network of the brain can be studied with MRI. PET with different tracer molecules allow diagnosis of metabolism pattern in the brain (18F-FDG-PET), modifications in the neurotransmitter system and detection of brain plaques associated with dementia such as amyloid β or Tau aggregates . Data acquired from both modalities allow the reliable and differential diagnosis, prediction of pre-dementia stages, monitoring therapy response and additional research information regarding the mechanism of the condition.

NCT ID: NCT04154215 Not yet recruiting - Clinical trials for Dementia With Lewy Bodies

FDG Metabolism in Dementia With Lewy Body (DLB) Patients as Indicated by PET Dynamic Acquisition

Start date: December 14, 2019
Phase: N/A
Study type: Interventional

Dementia with Lewy Body (DLB) is a common neurodegenerative disorder responsible to 15%-20% of the dementia cases in the elderly population. Dementia with Lewy Body (DLB) is a common neurodegenerative disorder responsible to 15%-20% of the dementia cases in the elderly population . This disorder belongs to the family of synucleinopathies, which are diseases characterized by the abnormal accumulation of the protein α-synuclein (α-syn) in neuronal and non-neuronal cells in the brain. The clinical symptoms of DLB include dementia with the presence of fluctuations in attention or alertness, recurrent visual hallucinations, spontaneous extrapyramidal motor features and REM sleep behavior disorder (RBD). Supportive clinical symptoms are severe sensitivity to antipsychotic agents, postural instability, repeated falls, syncope or other transient episodes of unresponsiveness, severe autonomic dysfunction e.g. constipation, orthostatic hypotension, urinary incontinence, hypersomnia, hyposmia, hallucinations in other modalities, systematized delusions, apathy, anxiety and depression. DLB differs from PD by the order of appearance of clinical symptoms. The diagnosis of DLB requires in addition to the clinical symptoms the existence biomarkers indicating the pathology. It is important to note that due to the complexity of DLB diagnosis, mainly due to the similarity of this syndrome to other dementia conditions, more than one biomarker is required to identify DLB [6]. The biomarkers contain indicative biomarkers and supportive biomarkers. Indicative biomarkers include a. Assessment of the integrity of dopaminergic system by either F-DOPA Positron Emission Tomography (PET) or by Ioflupane 123I (DaT) Single Photon Emission Tomography (SPECT) scans. b. Abnormal (low uptake) MIBG myocardial scintigraphy. c. Polysomnographic confirmation of REM sleep without atonia. Supportive biomarkers are: a. MRI/CT scans showing neuronal structural modifications with relative preservation of medial temporal lobe structures. b. Generalized low uptake on SPECT/PET perfusion/metabolism scan with reduced occipital activity +/- the cingulate island sign on 18F-fludeoxyglucose (FDG) PET imaging. c. Prominent posterior slow wave activity on EEG with periodic fluctuations in the pre-alpha/theta range. Biochemical biomarkers from the blood and spinal fluid were also investigated. These biomarkers include measurement of levels of Amyloid β, tau, and phospho-tau measurements. However, they do not allow differentiation between DLB and AD. α-syn was not proven as a biomarker.

NCT ID: NCT04132193 Not yet recruiting - Alzheimer Disease Clinical Trials

Processing of Music in Alzheimer Patients

MUKU-DEM
Start date: October 2019
Phase:
Study type: Observational

Correlation of musicality, brain atrophy in brain areas relevant for music processing and the stage of Alzheimer´s disease.