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

Not Applicable

Terminated

• Conditions: Alzheimer's Dementia With Behavioral Disturbance
• Interventions: Device: Acupuncture needle

• Registration Number: NCT03814382
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2018-12-19
• Study First Submitted QC: 2019-01-18
• Study First Posted: 2019-01-24
• Study Start: 2019-03-11
• Primary Completion: 2020-01-17
• Study Completion: 2020-02-01
• Results First Submitted: 2021-05-26
• Status Verified: 2022-01
• Results First Submitted QC: 2022-01-06
• Last Update Submitted: 2022-01-06
• Results First Posted: 2022-02-03
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acupuncture	Acupuncture needle	All subjects will receive up to 10 needles for 20 minutes for 1 treatment using acupuncture needles.

Primary Outcome Measures

Name	Time	Method
Heart Rate Variability as Measured by BioStamp	24 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	24 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.

Trial Locations

Locations (1)

Clinical Translational Research Unit; 🇺🇸 Charlestown, Massachusetts, United States