Ignite Creation Date:
2025-12-17 @ 1:43 PM
Ignite Modification Date:
2025-12-23 @ 11:09 AM
Study NCT ID:
NCT01055561
Status:
COMPLETED
Last Update Posted:
2016-05-30
First Post:
2010-01-22
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Acupuncture for Patients With Behavioural and Psychological Symptoms of Dementia
Sponsor:
Chengdu University of Traditional Chinese Medicine
Organization:
Study Overview
Official Title:
An Open-label Multi-center Safety and Tolerability Study of Acupuncture for Patients With Behavioural and Psychological Symptoms of Dementia & Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate the safety and tolerability of acupuncture for patients with BPSD \& healthy volunteers.
Detailed Description:
This open label study is designed to evaluate the safety and tolerability of acupuncture as a intervention for patients with Behavioral and Psychological Symptoms of Dementia (BPSD)\& healthy volunteers,and this study will enroll a total of 30(15 patients,15healthy volunteers) patients who are suffered from BPSD or healthy volunteers.The patients who have to be suitable for the standard of inclusion criteria will be included,and who have one condition of the exclusion criteria will be excluded,and so do the healthy volunteers.For each enrolled participant will obtain a baseline psychiatric and medical assessment, results of the Mini-Mental Status-Evaluation (MMSE),Behavioral Pathology in Alzheimer's Disease Rating Scale(BEHAVE-AD),Activity of Daily Living Scale(ADL)and other basic information prior to beginning acupuncture.For each participant will get acupuncture which once a day for 7 days running. During the trial the Questionnaire of Acupuncture-related Events have to be evaluated every day, and at the end of the intervention,all of the MMSE,BEHAV-AD,ADL and Treatment Emergent Symptom Scale (TESS)will be investigated.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: