Termination of study funding

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.

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.

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.

48 hours

AE definitions do not differ from this trial.

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.