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

NCT01055561 | Completed Phase 1 DMC

• 1 other identifier: 2008SZ0135
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer's Disease; Dementia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The Questionnaire of Acupuncture Events

  Every day during a 7 days trial

Secondary Outcomes (2)

• 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

Study Arms (2)

Patients

EXPERIMENTAL

Other: Acupuncture

Healthy volunteers

EXPERIMENTAL

Other: Acupuncture

Interventions

Acupuncture OTHER

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.

Also known as: Complementary and Alternative Medicine, Traditional Chinese Medicine

Healthy volunteers; Patients

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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
• 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

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead

Study Sites (1)

Yong Tang

Chengdu, Sichuan, 610075, China

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Behavior

Interventions

Acupuncture Therapy; Complementary Therapies; Medicine, Chinese Traditional

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Medicine, East Asian Traditional; Medicine, Traditional

Study Officials

• Yong Tang, M.D

  Chengdu University of TCM

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2010
• First Posted: January 25, 2010
• Study Start: January 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2011
• Last Updated: May 30, 2016

Record last verified: 2016-05

Locations

CN (1)