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

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

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.

Study Overview

• Status: Terminated
• Conditions: Alzheimer's Dementia With Behavioral Disturbance
• Intervention / Treatment: Device: Acupuncture needle

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Charlestown, Massachusetts, United States, 02124
      • Clinical Translational Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 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.	24 hours

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Alison McManus, MGH

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2019
• Primary Completion (Actual): January 17, 2020
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: December 19, 2018
• First Submitted That Met QC Criteria: January 18, 2019
• First Posted (Actual): January 24, 2019

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: January 6, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Problem Behavior; Dementia; Alzheimer Disease
• Other Study ID Numbers: 2018P002480

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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