Back to resultsAcupuncture to Reduce Anxiety in Alzheimer's Disease (AD) and AD Related Dementias
Primary Purpose
Alzheimer's Dementia With Behavioral Disturbance
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture needle
Sponsored by
About this trial
This is an interventional supportive care trial for Alzheimer's Dementia With Behavioral Disturbance
Eligibility 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.
Sites / Locations
- Clinical Translational Research Unit
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Acupuncture
Arm Description
All subjects will receive up to 10 needles for 20 minutes for 1 treatment using acupuncture needles.
Outcomes
Primary Outcome Measures
Heart Rate Variability as Measured by BioStamp
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.
Galvanic Skin Response
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03814382
First Posted
December 19, 2018
Last Updated
January 6, 2022
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03814382
Brief Title
Acupuncture to Reduce Anxiety in Alzheimer's Disease (AD) and AD Related Dementias
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
Termination of study funding
Study Start Date
March 11, 2019 (Actual)
Primary Completion Date
January 17, 2020 (Actual)
Study Completion Date
February 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Dementia With Behavioral Disturbance
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
All subjects will receive up to 10 needles for 20 minutes for 1 treatment using acupuncture needles.
Intervention Type
Device
Intervention Name(s)
Acupuncture needle
Intervention Description
Acupuncture needle
Primary Outcome Measure Information:
Title
Heart Rate Variability as Measured by BioStamp
Description
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.
Time Frame
24 hours
Title
Galvanic Skin Response
Description
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.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison McManus
Organizational Affiliation
MGH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Translational Research Unit
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02124
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Acupuncture to Reduce Anxiety in Alzheimer's Disease (AD) and AD Related Dementias
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