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Feasibility Study of Transcranial Ultrasound Stimulation on Alzheimer's Disease Patients (TUS)

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ClinicalTrials.gov Identifier: NCT03896698
Recruitment Status : Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : April 2, 2019
Sponsor:
Collaborator:
Taipei Veterans General Hospital, Taiwan
Information provided by (Responsible Party):
Feng-Yi Yang, National Yang Ming University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Device: Transcranial Ultrasound Stimulation Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Device Feasibility
Official Title: Feasibility Study of Transcranial Ultrasound Stimulation on Alzheimer's Disease Patients
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : November 30, 2020


Arm Intervention/treatment
Experimental: TUS treatment
AD patients with TUS treatment
Device: Transcranial Ultrasound Stimulation
TUS activate the brain cells

No Intervention: Non-TUS treatment
AD patients with Non-TUS treatment



Primary Outcome Measures :
  1. Device and procedure related adverse events recording [ Time Frame: up to 46 weeks after treatment ]
    Rate of adverse events following each treatment through end of study Clinical and MRI evaluation


Secondary Outcome Measures :
  1. Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) [ Time Frame: Change from baseline at 7, 12, 24, and 52 week ]
    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.

  2. Clinical Dementia Rating (CDR) [ Time Frame: Change from baseline at 12 and 52 week ]
    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.

  3. Neuropsychiatric Inventory Questionnaire (NPI-Q) [ Time Frame: Change from baseline at 12 and 52 week ]
    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.

  4. Transcranial Doppler (TCD) [ Time Frame: Changes in blood flow from baseline at 12 and 52 week ]
    Cerebral blood flow evaluation

  5. Magnetic Resonance Image (MRI) [ Time Frame: Change from baseline at 12 and 52 week ]
    Brain observation



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 55 and 90 years old
  2. Weight greater than 50 kg
  3. Male or Female
  4. Good understanding of written and verbal Chinese
  5. Geriatric Depression Scale (GDS) score of < 8
  6. Mild AD patients (Mini-Mental State Examination (MMSE) 20-26)
  7. Probable AD consistent with NIA/AA criteria
  8. The blood flow of bilateral middle cerebral artery M1 can be detected by Transcranial Color Doppler (TCD)
  9. Caregiver spending at least 10 hours per week with the patient
  10. Agreement to obey the rules of this study
  11. Use of cholinesterase inhibitors for AD (Aricept, Namenda, etc.) will be allowed as long as the participant has been on a stable dose for at least six months
  12. Does have a reliable caregiver in frequent contact with the patient and can accompany the patient to the clinic and treatment

Exclusion Criteria:

  1. Evidence of any other major neurologic or other physical illness that could produce cognitive deterioration, except for mild cognitive impairment (MCI) and any history of stroke or diabetes
  2. History of myocardial infarction within the previous year or unstable cardiac disease
  3. Any contraindications to MRI scanning such as metallic implants, claustrophibia or too large for MRI scanner
  4. History of liver disease or severely impaired renal function
  5. The blood flow of either unilateral middle cerebral artery M1 can't be detected by Transcranial Color Doppler (TCD)
  6. Major psychiatric disorders, such as bipolar disorder or schizophrenia, or persons with current untreated major depression
  7. Pregnant or breastfeeding women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896698


Contacts
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Contact: Jong-Ling Fuh, M.D. 886-2-28762522 jlfuh@vghtpe.gov.tw
Contact: Feng-Yi Yang, Ph.D. 886-2-28267281 fyyang@ym.edu.tw

Locations
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Taiwan
Taipei Veterans General Hospital Not yet recruiting
Taipei, Taiwan
Contact: Jong-Ling Fuh, M.D.         
Principal Investigator: Jong-Li Fuh, M.D.         
Sponsors and Collaborators
National Yang Ming University
Taipei Veterans General Hospital, Taiwan
Investigators
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Principal Investigator: Feng-Yi Yang, Ph.D. National Yang Ming University

Publications:

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Responsible Party: Feng-Yi Yang, Professor, National Yang Ming University
ClinicalTrials.gov Identifier: NCT03896698     History of Changes
Other Study ID Numbers: TUS01
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Feng-Yi Yang, National Yang Ming University:
Alzheimer's Disease
Transcranial Ultrasound Stimulation
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders