Trial Outcomes & Findings for Acupuncture to Reduce Anxiety in Alzheimer's Disease (AD) and AD Related Dementias (NCT NCT03814382)

Last Updated: 2022-02-03

Results Overview

We propose that acupuncture might acutely change Heart Rate Variability in AD/ADRD subjects with AIA. BioStamp will continuously measure participants' heart rate for 48 hours.

Recruitment status

TERMINATED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

24 hours

Results posted on

2022-02-03

Participant Flow

Participant milestones

Participant milestones
Measure	Acupuncture All subjects will receive up to 10 needles for 20 minutes for 1 treatment using acupuncture needles. Acupuncture needle: Acupuncture needle
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acupuncture n=10 Participants All subjects will receive up to 10 needles for 20 minutes for 1 treatment using acupuncture needles. Acupuncture needle: Acupuncture needle
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	66.33 years STANDARD_DEVIATION 7.685 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: The data was so noisy that is was unable to be analyzed

We propose that acupuncture might acutely change Heart Rate Variability in AD/ADRD subjects with AIA. BioStamp will continuously measure participants' heart rate for 48 hours.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 24 hours

Population: The data was so noisy that is was unable to be analyzed

We propose that acupuncture might acutely change Galvanic Skin Response in AD/ADRD subjects with AIA. Galvanic Skin Response measures sweating output in participants' fingers. The sweating response will be captured at both study visits.

Outcome measures

Outcome data not reported

Adverse Events

Acupuncture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jessica Gerber, DAc.

Massachusetts General Hospital

Phone: 617-724-1992

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place