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Acupuncture to Reduce Anxiety in Alzheimer's Disease (AD) and AD Related Dementias

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ClinicalTrials.gov Identifier: NCT03814382
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Steven E Arnold, Massachusetts General Hospital

Brief Summary:

The purpose of this study is to investigate the influence of acupuncture on heart rate variability, skin conductance (sweating), and rated behavioral expression of agitation, irritability, and anxiety and mood in qualifying adults with a diagnosis of cognitively unimpaired, or probable Alzheimer's Disease, Frontotemporal Dementia or Dementia with Lewy Bodies. Study subjects will all receive one real acupuncture treatment; mood scales will be assessed before and after.

Massachusetts General Hospital is paying for this research to be done.


Condition or disease Intervention/treatment Phase
Alzheimer's Dementia With Behavioral Disturbance Device: Acupuncture needle Not Applicable

Detailed Description:
Acupuncture is a system of integrative medicine that involves pricking the skin or tissues with needles, used to alleviate pain and to treat various physical, mental, and emotional conditions. Originating in ancient China, acupuncture is now widely practiced globally.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Exploring the Use of Acupuncture to Reduce Agitation, Irritability and Anxiety in Alzheimer's Disease and Alzheimer's Disease Related Dementias Utilizing Noninvasive Measures of Autonomic Nervous System Physiology and Actigraphy Biomarkers
Actual Study Start Date : March 11, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020


Arm Intervention/treatment
Experimental: Acupuncture
All subjects will receive up to 10 needles for 20 minutes for 1 treatment using acupuncture needles.
Device: Acupuncture needle
Acupuncture needle




Primary Outcome Measures :
  1. Heart Rate Variability as measured by BioStamp [ Time Frame: 48 hours ]
    We propose that acupuncture might acutely change Heart Rate Variability in AD/ADRD subjects with AIA. BioStamp will continuously measure participants' heart rate for 48 hours.

  2. Galvanic Skin Response [ Time Frame: 48 hours ]
    We propose that acupuncture might acutely change Galvanic Skin Response in AD/ADRD subjects with AIA. Galvanic Skin Response measures sweating output in participants' fingers. The sweating response will be captured at both study visits.



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Ages Eligible for Study:   55 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages 55-95 inclusive, male or female.
  • Diagnosis of CU, or probable AD, FTD or DLB as determined by established clinical criteria at screening14.
  • For the AIA symptomatic groups, a score of > 2 for Severity on at least 1 of the AIA-relevant items on the NPI-Q, i.e., Anxiety, Irritability/Lability, Agitation or Aggression.
  • For the CU and no neuropsychiatric symptoms group, NPI-Q score must be 0 for AIA-relevant items, i.e., Anxiety, Irritability/Lability, Agitation or Aggression.
  • No concurrent use of therapies with prohibitive effects on interpretation of HRV and SC measurements, e.g., those with major direct adrenergic or anticholinergic activities.
  • Stable doses (>2 weeks) of concurrent dementia or psychiatric drugs for those applicable.

Exclusion Criteria:

  • Atrial or junctional arrhythmias or other cardiac conditions, including pacemakers or other implantable devices that affect RR intervals or their measurement.
  • AIA symptoms or dementia so severe that subject cannot assent and cooperate with all study procedures or requires immediate rescue medication for behavioral control.
  • Seizure disorders or other potentially confounding medical, neurological or longstanding psychiatric illnesses.

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): NCT03814382


Contacts
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Contact: Katie Monahan 617-643-5265 KMONAHAN4@PARTNERS.ORG
Contact: Jessica Gerber 617-724-1992 JGERBER2@PARTNERS.ORG

Locations
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United States, Massachusetts
Clinical Translational Research Unit Recruiting
Charlestown, Massachusetts, United States, 02124
Contact: Jessica Gerber    617-724-1992    jgerber2@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Alison McManus MGH

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Responsible Party: Steven E Arnold, Managing Director Physician, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03814382     History of Changes
Other Study ID Numbers: 2018P002480
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Problem Behavior
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Behavioral Symptoms