Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-17 @ 1:43 PM
Ignite Modification Date:
2025-12-22 @ 12:56 PM
NCT ID:
NCT01055561
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
85 Years
Study:
NCT01055561
Study Brief:
Protocol Section:
NCT01055561