Acupuncture to Reduce Anxiety in Alzheimer's Disease (AD) and AD Related Dementias
Purpose
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.
Condition
- Alzheimer's Dementia With Behavioral Disturbance
Eligibility
- Eligible Ages
- Between 55 Years and 95 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Acupuncture |
All subjects will receive up to 10 needles for 20 minutes for 1 treatment using acupuncture needles. |
|
More Details
- Status
- Terminated
- Sponsor
- Massachusetts General Hospital
Study Contact
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.