Clinical trial NCT03814382: Acupuncture to Reduce Anxiety in Alzheimer's Disease (AD) and AD Related Dementias
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alzheimer's Dementia With Behavioral Disturbance
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-01-24
Enrollment: 10
Sex: ALL
Minimum age (years): 55
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Heart Rate Variability as Measured by BioStamp
timeFrame: 24 hours
measure: Galvanic Skin Response
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Clinical Translational Research Unit
state: Massachusetts
Study officials:
affiliation: MGH
name: Alison McManus
role: PRINCIPAL_INVESTIGATOR
References: