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

Mass General Brigham

Status

Terminated

Conditions

Alzheimer's Dementia With Behavioral Disturbance

Treatments

Device: Acupuncture needle

Study type

Interventional

Funder types

Other

Identifiers

NCT03814382

2018P002480

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

55 to 95 years old

Volunteers

Accepts Healthy Volunteers

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.