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

This study has been completed.
Sponsor:
Information provided by:
Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01055561
First received: January 22, 2010
Last updated: April 24, 2011
Last verified: April 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Alzheimer's Disease
Dementia
Healthy Volunteers
 Other: Acupuncture
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Multi-center Safety and Tolerability Study of Acupuncture for Patients With Behavioural and Psychological Symptoms of Dementia & Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chengdu University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • The Questionnaire of Acupuncture Events [ Time Frame: Every day during a 7 days trial ] [ Designated as safety issue: Yes ]

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） [ Time Frame: Baseline and 1week after the trial begen ] [ Designated as safety issue: Yes ]
  • Treatment Emergent Symptom Scale (TESS) [ Time Frame: Baseline and 2 weeks after the trial begen ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: January 2010
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Complementary and Alternative Medicine
  • Traditional Chinese Medicine
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:
  • Complementary and Alternative Medicine
  • Traditional Chinese Medicine

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.

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01055561

Locations
China, Sichuan
Yong Tang
Chengdu, Sichuan, China, 610075
Sponsors and Collaborators
Chengdu University of Traditional Chinese Medicine
Investigators
Study Director: Yong Tang, M.D Chengdu University of TCM
  More Information

No publications provided

Responsible Party: College of Acupuncture & Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01055561     History of Changes
Other Study ID Numbers: 2008SZ0135
Study First Received: January 22, 2010
Last Updated: April 24, 2011
Health Authority: United States: Institutional Review Board
China: Food and Drug Administration

Keywords provided by Chengdu University of Traditional Chinese Medicine:
Acupuncture
Behavioral and Psychological Symptoms of Dementia
BPSD
MMSE
 BEHAVE-AD
The Questionnaire of Acupuncture Events
healthy volunteers

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013