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

NCT03814382 | Terminated Results FDA Device

• 1 other identifier: 2018P002480
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Dementia With Behavioral Disturbance

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Acupuncture

EXPERIMENTAL

All subjects will receive up to 10 needles for 20 minutes for 1 treatment using acupuncture needles.

Device: Acupuncture needle

Interventions

Acupuncture needle DEVICE

Acupuncture needle

Acupuncture

Eligibility Criteria

• Age: 55 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Clinical Translational Research Unit

Charlestown, Massachusetts, 02124, United States

Location

Limitations and Caveats

This study Investigated a wearable technology for HRV and galvanic skin response as an indicator of autonomic function for use in tracking people over time in clinical trials. We observed high day to day variability in measures that led us to conclude that this technology is not useful for our clinical trials in its current state.

Results Point of Contact

• Title: Jessica Gerber, DAc.
• Organization: Massachusetts General Hospital

jgerber2@mgh.harvard.edu

617-724-1992

Study Officials

• Alison McManus

  MGH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Managing Director Physician

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: January 24, 2019
• Study Start: March 11, 2019
• Primary Completion: January 17, 2020
• Study Completion: February 1, 2020
• Last Updated: February 3, 2022
• Results First Posted: February 3, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)