CompletedPhase 1

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

China30 participantsStarted 2010-01

Plain-language summary

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

Age range60 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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
✕. 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

The Questionnaire of Acupuncture Events

Timeframe: Every day during a 7 days trial

NCT IDNCT01055561

SponsorChengdu University of Traditional Chinese Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-02

Who can participate

Age range60 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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
✕. 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