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A Study of Acupuncture for Patients With Behavioural and Psychological Symptoms of Dementia

Primary Purpose

Alzheimer's Disease, Dementia

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Acupuncture

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Acupuncture, Behavioral and Psychological Symptoms of Dementia, BPSD, MMSE, BEHAVE-AD, The Questionnaire of Acupuncture Events, healthy volunteers

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

The eligibility criteria of the patients arm:

Inclusion Criteria:

patients who aged 60 to 85(inclusive) years
The MMSE score of patients must be between 5 to 26
Patients with diagnosis of Alzheimer's Disease according to DSM-Ⅳ（Diagnostic and Statistical Manual of Mental Disorders Fourth Edition)
patients have one or more "target symptoms" of Behavioral and Psychological Symptoms of Dementia(BPSD) on the behavioral psychology in Alzheimer's disease rating scale (BEHAVE-AD),and the "target symptoms " of BEHAVE-AD have to have occurred nearly daily during the previous week or at least intermittently for 4 weeks
Patients (or a legally acceptable representative)have signed the informed consent form

Exclusion Criteria:

Received a diagnosis of a primary psychotic disorder (e.g.schizophrenia，bipolar disorder, severe or recurrent depression),other dementia such as vascular dementia,complex dementia or Lewy-body dementia,or psychosis,agitation, or aggression that could be better accounted for by another medical condition, or substance abuse
Had severe system disease (e.g., cardiovascular, hepatorenal, hematopoietic system) or infectious disease
Received medication (e.g.,benzodiazepines, antipsychotics, or anticholinergics)which could treat BPSD within 2 weeks prior to the first acupuncture of the study
Participated in any clinical trial of drug within 4 weeks prior to the study
History of taking acupuncture

The eligibility criteria of the healthy volunteers arm:

Inclusion Criteria:

Healthy volunteers aged 60 to 85(inclusive) years who have provided written informed consent
MMSE> or =27
Have relative better health condition who do not suffered from severe system disease (e.g.,cardiovascular, hepatorenal, hematopoietic system) or infectious disease

Exclusion Criteria:

History of significant neurological (including history of seizures,EEG abnormalities or dementia) or psychotic disorder (e.g.schizophrenia，bipolar disorder, severe or recurrent depression)
History of drug or alcohol abuse
History of taking medication that may be impair the function of cognition or psychotic behavior within 4 weeks before the study
Participated in any clinical trial of drug within 4 weeks prior to the study
History of taking acupuncture

Sites / Locations

Yong Tang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Patients

Healthy volunteers

Arm Description

Outcomes

Primary Outcome Measures

The Questionnaire of Acupuncture Events

Secondary Outcome Measures

Change from baseline on Mini-Mental State-Examination（MMSE）,The Behavioral Pathology in Alzheimer's Disease Rating Scale（BEHAVE-AD）and Activity of Daily Living Scale（ADL）

Treatment Emergent Symptom Scale (TESS)

Full Information

NCT ID

NCT01055561

First Posted

January 22, 2010

Last Updated

May 27, 2016

Sponsor

Chengdu University of Traditional Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT01055561

Brief Title

A Study of Acupuncture for Patients With Behavioural and Psychological Symptoms of Dementia

Official Title

An Open-label Multi-center Safety and Tolerability Study of Acupuncture for Patients With Behavioural and Psychological Symptoms of Dementia & Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chengdu University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease, Dementia

Keywords

Acupuncture, Behavioral and Psychological Symptoms of Dementia, BPSD, MMSE, BEHAVE-AD, The Questionnaire of Acupuncture Events, healthy volunteers

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients

Arm Type

Experimental

Arm Title

Healthy volunteers

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Acupuncture

Other Intervention Name(s)

Complementary and Alternative Medicine, Traditional Chinese Medicine

Intervention Description

Participators will be stimulated at specific acupuncture points as determined for the disease by the professional acupuncturists, and acupuncture once a day,last for one week.

Primary Outcome Measure Information:

Title

The Questionnaire of Acupuncture Events

Time Frame

Every day during a 7 days trial

Secondary Outcome Measure Information:

Title

Change from baseline on Mini-Mental State-Examination（MMSE）,The Behavioral Pathology in Alzheimer's Disease Rating Scale（BEHAVE-AD）and Activity of Daily Living Scale（ADL）

Time Frame

Baseline and 1week after the trial begen

Title

Treatment Emergent Symptom Scale (TESS)

Time Frame

Baseline and 2 weeks after the trial begen

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

The eligibility criteria of the patients arm: Inclusion Criteria: patients who aged 60 to 85(inclusive) years The MMSE score of patients must be between 5 to 26 Patients with diagnosis of Alzheimer's Disease according to DSM-Ⅳ（Diagnostic and Statistical Manual of Mental Disorders Fourth Edition) patients have one or more "target symptoms" of Behavioral and Psychological Symptoms of Dementia(BPSD) on the behavioral psychology in Alzheimer's disease rating scale (BEHAVE-AD),and the "target symptoms " of BEHAVE-AD have to have occurred nearly daily during the previous week or at least intermittently for 4 weeks Patients (or a legally acceptable representative)have signed the informed consent form Exclusion Criteria: Received a diagnosis of a primary psychotic disorder (e.g.schizophrenia，bipolar disorder, severe or recurrent depression),other dementia such as vascular dementia,complex dementia or Lewy-body dementia,or psychosis,agitation, or aggression that could be better accounted for by another medical condition, or substance abuse Had severe system disease (e.g., cardiovascular, hepatorenal, hematopoietic system) or infectious disease Received medication (e.g.,benzodiazepines, antipsychotics, or anticholinergics)which could treat BPSD within 2 weeks prior to the first acupuncture of the study Participated in any clinical trial of drug within 4 weeks prior to the study History of taking acupuncture The eligibility criteria of the healthy volunteers arm: Inclusion Criteria: Healthy volunteers aged 60 to 85(inclusive) years who have provided written informed consent MMSE> or =27 Have relative better health condition who do not suffered from severe system disease (e.g.,cardiovascular, hepatorenal, hematopoietic system) or infectious disease Exclusion Criteria: History of significant neurological (including history of seizures,EEG abnormalities or dementia) or psychotic disorder (e.g.schizophrenia，bipolar disorder, severe or recurrent depression) History of drug or alcohol abuse History of taking medication that may be impair the function of cognition or psychotic behavior within 4 weeks before the study Participated in any clinical trial of drug within 4 weeks prior to the study History of taking acupuncture

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yong Tang, M.D

Organizational Affiliation

Chengdu University of TCM

Official's Role

Study Director

Facility Information:

Facility Name

Yong Tang

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610075

Country

China

12. IPD Sharing Statement

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A Study of Acupuncture for Patients With Behavioural and Psychological Symptoms of Dementia

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