Status:
TERMINATED
Acupuncture to Reduce Anxiety in Alzheimer's Disease (AD) and AD Related Dementias
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Alzheimer's Dementia With Behavioral Disturbance
Eligibility:
All Genders
55-95 years
Phase:
NA
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...
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. Origina...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03814382
Start Date
March 11 2019
End Date
February 1 2020
Last Update
February 3 2022
Active Locations (1)
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1
Clinical Translational Research Unit
Charlestown, Massachusetts, United States, 02124