Acupuncture to Reduce Anxiety in Alzheimer's Disease (AD) and AD Related Dementias
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|ClinicalTrials.gov Identifier: NCT03814382|
Recruitment Status : Terminated (Termination of study funding)
First Posted : January 24, 2019
Last Update Posted : May 19, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 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|
|Actual Primary Completion Date :||January 17, 2020|
|Actual Study Completion Date :||February 1, 2020|
All subjects will receive up to 10 needles for 20 minutes for 1 treatment using acupuncture needles.
Device: Acupuncture needle
- 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.
- 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.
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
|United States, Massachusetts|
|Clinical Translational Research Unit|
|Charlestown, Massachusetts, United States, 02124|
|Principal Investigator:||Alison McManus||MGH|