Acupuncture to Reduce Anxiety in Alzheimer's Disease (AD) and AD Related Dementias
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03814382|
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : April 18, 2019
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)|
|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|
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
|Contact: Katie Monahan||617-643-5265||KMONAHAN4@PARTNERS.ORG|
|Contact: Jessica Gerber||617-724-1992||JGERBER2@PARTNERS.ORG|
|United States, Massachusetts|
|Clinical Translational Research Unit||Recruiting|
|Charlestown, Massachusetts, United States, 02124|
|Contact: Jessica Gerber 617-724-1992 email@example.com|
|Principal Investigator:||Alison McManus||MGH|