An interventional study of Transcranial Ultrasound Stimulation in Alzheimer Disease, sponsored by National Yang Ming Chiao Tung University. Status unknown at 1 site in Taiwan. Open to participants aged 55 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-04-28.
Sponsored by National Yang Ming Chiao Tung University · Not applicable, Interventional, and Device feasibility
Currently, the main treatment method for Alzheimer's disease (AD) is chemotherapy. However, the effectiveness of drugs is moderate and there are several side effects. In this clinical trial, the investigators would like to activate the brain by the transcranial ultrasound stimulation (TUS). This is a feasibility study to evaluate the safety and initial effectiveness of TUS for the treatment of patients with mild AD.
The purpose of this study is to verify the feasibility of low intensity transcranial ultrasound stimulation (TUS) for patients with mild Alzheimer's disease (AD). As a secondary aim, the investigators will explore whether the TUS is associated with improvement in cognitive functioning six and forty-six weeks following the intervention.
Subjects will be randomly assigned to one of two experimental groups which with or without the TUS administration.
The investigators will study up to 20 subjects with mild AD. Initially, subjects will undergo a screening assessment with a study physician to determine medical and psychiatric history, establish AD diagnosis, and undergo a bold draw. Subjects that meet criteria and agree to participate in the study will undergo a follow-up visit. In the baseline measurement visit, participants will first undergo neuropsychological testing. Participants will be randomly assigned to one of two groups. Participants will then be administrated TUS treatment for six weeks. Subsequently, participants will undergo a series of neuropsychological test. A final follow-up assessment will be administered at forty-six weeks.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 10 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →National Yang Ming Chiao Tung University is the lead sponsor of 201 studies on the registry; 58 are open to participants now.
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Exclusion Criteria:
AD patients with TUS treatment
Device: Transcranial Ultrasound Stimulation
AD patients with Non-TUS treatment
TUS activate the brain cells
Device and procedure related adverse events recording
Rate of adverse events following each treatment through end of study Clinical and MRI evaluation
Time frame: up to 46 weeks after treatment
Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
ADAS was designed to measure the severity of the most important symptoms of Alzheimer's disease (AD). Its subscale ADAS-cog is the most popular cognitive testing instrument used in clinical trials of nootropics. It consists of 11 tasks measuring the disturbances of memory, language, praxis, attention and other cognitive abilities which are often referred to as the core symptoms of AD. The test administrator adds up points for the errors in each task of the ADAS-Cog for a total score. Total scores range from 0-70. The greater the dysfunction, the greater the score.
Time frame: Change from baseline at 7, 12, 24, and 52 week
Clinical Dementia Rating (CDR)
The Clinical Dementia Rating or CDR is a numeric scale used to quantify the severity of symptoms of dementia (i.e. its 'stage'). Using a structured-interview protocol, qualified health professional assesses a patient's cognitive and functional performance in six areas: memory, orientation, judgment \& problem solving, community affairs, home \& hobbies, and personal care. Scores in each of these are combined to obtain a composite score ranging from 0 through 3, with 0 meaning of no symptoms, 0.5 very mild dementia, 1 mild dementia, 2 moderate dementia and 3 severe dementia.
Time frame: Change from baseline at 12 and 52 week
Neuropsychiatric Inventory Questionnaire (NPI-Q)
NPI-Q is a carer-based tool that assesses the possible presence of 12 symptoms in dementia cases, including delusions, hallucinations, agitation/aggression, dysphoria/depression, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviors, night-time behavioral disturbances and appetite/eating disturbances. The severity scale has scores ranging from 1 to 3 points (1=mild; 2=moderate; and 3=severe) and the scale for assessing caregiver distress has scores ranging from 0 to 5 points (0=no distress; 1=minimal distress; 2=mild distress; 3=moderate distress; 4=severe distress; and 5=extreme distress). The total scores of severity and caregiver stress are summed of each 12 items separately, with with higher scores indicating a greater number of neuropsychiatric symptoms or distress.
Time frame: Change from baseline at 12 and 52 week
Transcranial Doppler (TCD)
Cerebral blood flow evaluation
Time frame: Changes in blood flow from baseline at 12 and 52 week
Magnetic Resonance Image (MRI)
Brain observation
Time frame: Change from baseline at 12 and 52 week
This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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National Yang Ming Chiao Tung University