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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01055561
• Other study ID #: 2008SZ0135
• Status: Completed
• Phase: Phase 1
• First received: January 22, 2010
• Last updated: May 27, 2016
• Start date: January 2010
• Est. completion date: March 2011

Study information

• Verified date: May 2016
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the safety and tolerability of acupuncture for patients with BPSD & healthy volunteers.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

The eligibility criteria of the patients arm:

Inclusion Criteria:

1. patients who aged 60 to 85(inclusive) years

2. The MMSE score of patients must be between 5 to 26

3. Patients with diagnosis of Alzheimer's Disease according to DSM-?(Diagnostic and Statistical Manual of Mental Disorders Fourth Edition)

4. 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

5. Patients (or a legally acceptable representative)have signed the informed consent form

Exclusion Criteria:

1. 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

2. Had severe system disease (e.g., cardiovascular, hepatorenal, hematopoietic system) or infectious disease

3. Received medication (e.g.,benzodiazepines, antipsychotics, or anticholinergics)which could treat BPSD within 2 weeks prior to the first acupuncture of the study

4. Participated in any clinical trial of drug within 4 weeks prior to the study

5. History of taking acupuncture

The eligibility criteria of the healthy volunteers arm:

Inclusion Criteria:

1. Healthy volunteers aged 60 to 85(inclusive) years who have provided written informed consent

2. MMSE> or =27

3. Have relative better health condition who do not suffered from severe system disease (e.g.,cardiovascular, hepatorenal, hematopoietic system) or infectious disease

Exclusion Criteria:

1. History of significant neurological (including history of seizures,EEG abnormalities or dementia) or psychotic disorder (e.g.schizophrenia,bipolar disorder, severe or recurrent depression)

2. History of drug or alcohol abuse

3. History of taking medication that may be impair the function of cognition or psychotic behavior within 4 weeks before the study

4. Participated in any clinical trial of drug within 4 weeks prior to the study

5. History of taking acupuncture

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia

Intervention

Other:
• Acupuncture
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.

Locations

Country	Name	City	State
China	Yong Tang	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Questionnaire of Acupuncture Events		Every day during a 7 days trial	Yes
Secondary	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)		Baseline and 1week after the trial begen	Yes
Secondary	Treatment Emergent Symptom Scale (TESS)		Baseline and 2 weeks after the trial begen	Yes