Alzheimer's DiseasePhase 1NCT01055561
A Study of Acupuncture for Patients With Behavioural and Psychological Symptoms of Dementia
A Phase 1 study testing Acupuncture in people with Alzheimer's Disease and Dementia, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The purpose of the study is to evaluate the safety and tolerability of acupuncture for patients with BPSD \& healthy volunteers. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Dementia
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Mar 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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:
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Alzheimer's Disease, Dementia
- Being tested
- Acupuncture
- Keywords
- Acupuncture, Behavioral and Psychological Symptoms of Dementia, BPSD, MMSE, BEHAVE-AD, The Questionnaire of Acupuncture Events, healthy volunteers
- Medical subject headings
- Alzheimer Disease, Dementia, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Also called Complementary and Alternative Medicine, Traditional Chinese Medicine
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Not described Receives: Other: Acupuncture |
| Healthy volunteers | Experimental | Not described Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Questionnaire of Acupuncture Events
Measured: 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）
Measured: Baseline and 1week after the trial begen
Treatment Emergent Symptom Scale (TESS)
Measured: Baseline and 2 weeks after the trial begen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionFeb 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yong Tang, M.D, Study director, Chengdu University of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055561
- Sponsor's protocol ID
- 2008SZ0135
- Status last verified
- May 2016
- First submitted
- 22 Jan 2010
- Last updated
- 30 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Multi-center Safety and Tolerability Study of Acupuncture for Patients With Behavioural and Psychological Symptoms of Dementia & Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01055561
- Acronym / sponsor ID
- 2008SZ0135
- Conditions
- Alzheimer's Disease, Dementia
- Keywords
- Acupuncture, Behavioral and Psychological Symptoms of Dementia, BPSD, MMSE, BEHAVE-AD, The Questionnaire of Acupuncture Events, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 25 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the safety and tolerability of acupuncture for patients with BPSD \& healthy volunteers.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: Acupuncture |
| Healthy volunteers | Experimental | Other: Acupuncture |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAlso: Complementary and Alternative Medicine, Traditional Chinese MedicineParticipators 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 | Healthy volunteers, Patients |
Primary outcome
The Questionnaire of Acupuncture Events
Time frame: Every day during a 7 days trial
2 secondary outcomes
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
Treatment Emergent Symptom Scale (TESS)
Time frame: Baseline and 2 weeks after the trial begen
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Tang, M.D study director
Chengdu University of TCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acupuncture in people with Alzheimer's Disease and Dementia, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Questionnaire of Acupuncture Events (time frame: Every day during a 7 days trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2016.