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

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

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

Study Overview

• Status: Completed
• Conditions: Dementia; Alzheimer's Disease
• Intervention / Treatment: Other: Acupuncture

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610075
      • Yong Tang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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-Ⅳ（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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy volunteers	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.; Other Names: Traditional Chinese Medicine; Complementary and Alternative Medicine
Experimental: Patients	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.; Other Names: Traditional Chinese Medicine; Complementary and Alternative Medicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Questionnaire of Acupuncture Events	Every day during a 7 days trial

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Treatment Emergent Symptom Scale (TESS)	Baseline and 2 weeks after the trial begen

Collaborators and Investigators

• Sponsor: Chengdu University of Traditional Chinese Medicine
• Investigators: Study Director: Yong Tang, M.D, Chengdu University of TCM

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: January 22, 2010
• First Submitted That Met QC Criteria: January 22, 2010
• First Posted (Estimate): January 25, 2010

Study Record Updates

• Last Update Posted (Estimate): May 30, 2016
• Last Update Submitted That Met QC Criteria: May 27, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Acupuncture; healthy volunteers; BPSD; Behavioral and Psychological Symptoms of Dementia; MMSE; BEHAVE-AD; The Questionnaire of Acupuncture Events
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: 2008SZ0135