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

Stopped early · Not applicable

Conditions studied: Alzheimer's Dementia With Behavioral Disturbance

In brief

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.

Key facts

Study ID

NCT03814382

Run by

Massachusetts General Hospital

People needed

10

Starts

2019-03-11

Expected to finish

2020-02-01

Last updated by the study team

2022-02-03

Who can join

Age: 55 and older, up to 95. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical Translational Research Unit — Charlestown, Massachusetts, United States

Full record on ClinicalTrials.gov

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