Cognitive ImpairmentPhase 2NCT02305836
Effect of Electroacupuncture Combined With Donepezil for Treating Alzheimer's Disease
A Phase 2 study testing acupuncture and donepezil in people with Cognitive Impairment, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
A prospective randomized controlled trial aimed at assessing if electroacupuncture (EA) combined with donepezil is more effective than donepezil for improving the cognitive function of AD patients. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- acupuncture and donepezil
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 1 siteChina
- Study dates
- Jun 2017to Dec 2019
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants meeting all of the following criteria will be included in this trial: 1) the diagnostic criteria of Neurological Communicative Disorders and Stroke and the Alzheimer Disease and Related Disorders Association (NINCDS-ADRDA) or the Operational Criteria for the Diagnosis of Alzheimer's disease (OCDAD), 2) aged between 60-85 years, 3) cognitive impairment based on the scores of the Chinese version of the Mini Mental State Examination (MMSE) (illiteracy group ≤19, primary school group ≤22, junior high school and high school group ≤23, and well-educated group ≤26), 4) absence of depression (via an emotional assessment), 5) Magnetic Resonance Imaging (MRI) confirmation of atrophy of the hippocampus or the medial temporal lobe volume, 6) the Medial Temporal Lobe Atrophy Rating Scale (MTA-scale) score (≥ 2 for those under 75 years, and ≥ 3 for those over 75 years).
Who cannot join
- Participants meeting any one of the following criteria will be excluded from this trial: 1) Cognitive impairment caused by other factors (e.g. vascular dementia, dementia with Lewy's bodies, frontotemporal dementia, hormone or metabolic abnormalities, hypothyroidism, folic acid or vitamin B12 deficiency, delirium or other mental and emotional disorders [such as schizophrenia and depression]), 2) a serious heart condition, hepatic disease, renal system disease, hematopoietic system disease, or malnutrition of the whole body, 3) aphasia or decreased vision that is severe, blindness, disturbance of consciousness, or participants who cannot cooperate with the related examinations due to physical disability, 4) anticoagulant treatments such as warfarin or heparin, 5) use of pacemakers or participants too afraid of acupuncture, or 6) acupuncture or donepezil treatment in the past 30 days.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
Beijing, 100053
Weina Peng, 86-18610935028, wnpeng@hotmail.com
About this study
Official title: The Effect of Electroacupuncture Combined With Donepezil on Cognitive Function in Alzheimer's Disease Patients: Study Protocol for a Randomized Controlled Trial
A prospective randomized controlled trial aimed at assessing if electroacupuncture (EA) combined with donepezil is more effective than donepezil for improving the cognitive function of AD patients. The hypothesis of this study is as follow:
- Is the short-term effect of EA combined with donepezil better than donepezil on improving cognitive function of patients with Alzheimer's disease after 12 weeks' treatment?
- Whether the effect of EA combined with donepezil on improving cognitive function can last until the end of 6 months' follow-up?
Read the detailed description
- Patient registry: Participants experiencing cognitive impairment will be recruited will be recruited at Guang'anmen Hospital, Beijing, China, via web or posters. A neurologist will make the diagnosis. Randomization will be performed by the pharmacological assessment center at Guang'anmen Hospital.
- Sample size: The calculation of sample size is based on the primary outcome that the change from baseline in ADAS-cog. According to previous studies [26], 39% of patients showed an improvement of at least 4 points on the ADAS-cog after treating by donepezil. We estimated the rate 39% in the donepezil group and 55% in the EA combined with donepezil group. 304 participants were needed to provide 80% power at a significant level of 5% using analysis of variance. The total sample size required for the study is 334 (167 each group) assuming a 10% loss to follow-up.
- Quality control
- Investigators participating in this trial will take a strict course about the process of randomization, manipulation of electroacupuncture, selection of patients, the whole process of this trial and request for filling out case report form in order to improve the internal consistency of observation between different researchers.
- The process of randomization will be under a rigorous control.
- This trial has a specific inclusion and exclusion criteria.
- Both outcome assessors and statisticians will be blinding.
- Patients will sign the informed consent voluntarily and a good relationship between researchers and patients will be established in order to improve patients' compliance. Participants will have a detailed record of the contact information easy for follow-up.
- The standard of the drugs, acupuncture apparatus, inspection equipment are consistent for the patients in the two groups.
- Outcome assessment, completion of case report forms and data management will be under a rigorous supervision.
- Conditions
- Cognitive Impairment
- Being tested
- acupuncture, donepezil
- Keywords
- Electroacupuncture, Donepezil, Alzheimer's disease, Randomized controlled trial
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
Also called electroacupuncture
For GV16, the needle in length of 25mm will be inserted obliquely and downward towards mandibular direction slowly to a depth of 0.5. And the needle will be pulled out after "de qi" without being retained. For Shang Yintang, GV20 and GV24, the needle will be inserted with a 30°angle to a depth of about 0.5 cun to the subperiosteum until the patients have a strong sense that the needle is being heavily pressed. For EX-HN5 and KI 4 in both sides, the needle will be outward and obliquely inserted to the same depth of 1 cun and the needle will be manipulated with an even lifting and thrusting method to make the patients feel soreness and distention. The electric stimulator will be put on GV20, GV24 and EX-HN5 in both sides with a spare-dense wave, 10/50 Hz, 0.5-5.0 mA. The current intensity will be increased until the patients can not stand.
donepezilDrug
Also called Aricept
cholinesterase inhibitors (ChE-Is)
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture combined with donepezil | Experimental | Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks). Receives: Procedure: acupuncture |
| donepezil | Active comparator | Donepezil will be given once daily before bed-time for the first 4-6 weeks. Based on the treatment effect, the dosage may be increased to 10 mg once daily before bed-time for the next 6-8 weeks. Donepezil will be taken for continuous 24 weeks. The full course of treatment is 36 weeks. Receives: Drug: donepezil |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of total ADAS-cog score from baseline
The maximum score of ADAS-cog is 70 including 15 items of cognitive dysfunction assessment. The higher values indicate higher degree of deficit.
Measured: week 12 ± 3 days
Secondary outcomes (7)
change of total MMSE score from baseline
MMSE score are commonly used for estimating the severity of cognitive impairment with maximum score of 30. The questions in this scale included orientation to time, orientation to place, attention and calculation, recall of three words and visual construction.
Measured: week 12 ± 3 days
change of total MMSE score from baseline
Measured: week 36 ± 3 days
change of total ADCS-ADL score score from baseline
ADCS-ADL score contains 19 domains about assessment of basic and operational ability of daily living.
Measured: week 12 ± 3 days
change of total ADCS-ADL score score from baseline
Measured: week 36 ± 3 days
change of total QoL-AD score score from baseline
QOL-AD score which includes physical health, mental health, social and financial assessment and QOL domains is completed by both patients and caregivers.
Measured: week 12 ± 3 days
change of total QoL-AD score score from baseline
Measured: week 36 ± 3 days
change of total ADAS-cog score from baseline
Measured: week 36 ± 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startJun 2017 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 334 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weina Peng, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Weina Peng, Study director, Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305836
- Sponsor's protocol ID
- 2014S291
- Status last verified
- May 2017
- First submitted
- 13 Nov 2014
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Peng W, Zhou J, Xu M, Feng Q, Bin L, Liu Z. The effect of electroacupuncture combined with donepezil on cognitive function in Alzheimer's disease patients: study protocol for a randomized controlled trial. Trials. 2017 Jul 3;18(1):301. doi: 10.1186/s13063-017-2052-y.
PubMed 28673322
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Electroacupuncture Combined With Donepezil on Cognitive Function in Alzheimer's Disease Patients: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02305836
- Acronym / sponsor ID
- 2014S291
- Conditions
- Cognitive Impairment
- Keywords
- Electroacupuncture, Donepezil, Alzheimer's disease, Randomized controlled trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 334 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- Jun 2017 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 3 Dec 2014 (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.
A prospective randomized controlled trial aimed at assessing if electroacupuncture (EA) combined with donepezil is more effective than donepezil for improving the cognitive function of AD patients. The hypothesis of this study is as follow:
- Is the short-term effect of EA combined with donepezil better than donepezil on improving cognitive function of patients with Alzheimer's disease after 12 weeks' treatment?
- Whether the effect of EA combined with donepezil on improving cognitive function can last until the end of 6 months' follow-up?
Detailed description
- Patient registry: Participants experiencing cognitive impairment will be recruited will be recruited at Guang'anmen Hospital, Beijing, China, via web or posters. A neurologist will make the diagnosis. Randomization will be performed by the pharmacological assessment center at Guang'anmen Hospital.
- Sample size: The calculation of sample size is based on the primary outcome that the change from baseline in ADAS-cog. According to previous studies [26], 39% of patients showed an improvement of at least 4 points on the ADAS-cog after treating by donepezil. We estimated the rate 39% in the donepezil group and 55% in the EA combined with donepezil group. 304 participants were needed to provide 80% power at a significant level of 5% using analysis of variance. The total sample size required for the study is 334 (167 each group) assuming a 10% loss to follow-up.
- Quality control
- Investigators participating in this trial will take a strict course about the process of randomization, manipulation of electroacupuncture, selection of patients, the whole process of this trial and request for filling out case report form in order to improve the internal consistency of observation between different researchers.
- The process of randomization will be under a rigorous control.
- This trial has a specific inclusion and exclusion criteria.
- Both outcome assessors and statisticians will be blinding.
- Patients will sign the informed consent voluntarily and a good relationship between researchers and patients will be established in order to improve patients' compliance. Participants will have a detailed record of the contact information easy for follow-up.
- The standard of the drugs, acupuncture apparatus, inspection equipment are consistent for the patients in the two groups.
- Outcome assessment, completion of case report forms and data management will be under a rigorous supervision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture combined with donepezil | Experimental | Procedure: acupunctureEvery session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks). |
| donepezil | Active comparator | Drug: donepezilDonepezil will be given once daily before bed-time for the first 4-6 weeks. Based on the treatment effect, the dosage may be increased to 10 mg once daily before bed-time for the next 6-8 weeks. Donepezil will be taken for continuous 24 weeks. The full course of treatment is 36 weeks. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants meeting all of the following criteria will be included in this trial: 1) the diagnostic criteria of Neurological Communicative Disorders and Stroke and the Alzheimer Disease and Related Disorders Association (NINCDS-ADRDA) or the Operational Criteria for the Diagnosis of Alzheimer's disease (OCDAD), 2) aged between 60-85 years, 3) cognitive impairment based on the scores of the Chinese version of the Mini Mental State Examination (MMSE) (illiteracy group ≤19, primary school group ≤22, junior high school and high school group ≤23, and well-educated group ≤26), 4) absence of depression (via an emotional assessment), 5) Magnetic Resonance Imaging (MRI) confirmation of atrophy of the hippocampus or the medial temporal lobe volume, 6) the Medial Temporal Lobe Atrophy Rating Scale (MTA-scale) score (≥ 2 for those under 75 years, and ≥ 3 for those over 75 years).
Key exclusion criteria (1 listed)
- Participants meeting any one of the following criteria will be excluded from this trial: 1) Cognitive impairment caused by other factors (e.g. vascular dementia, dementia with Lewy's bodies, frontotemporal dementia, hormone or metabolic abnormalities, hypothyroidism, folic acid or vitamin B12 deficiency, delirium or other mental and emotional disorders [such as schizophrenia and depression]), 2) a serious heart condition, hepatic disease, renal system disease, hematopoietic system disease, or malnutrition of the whole body, 3) aphasia or decreased vision that is severe, blindness, disturbance of consciousness, or participants who cannot cooperate with the related examinations due to physical disability, 4) anticoagulant treatments such as warfarin or heparin, 5) use of pacemakers or participants too afraid of acupuncture, or 6) acupuncture or donepezil treatment in the past 30 days.
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: electroacupunctureFor GV16, the needle in length of 25mm will be inserted obliquely and downward towards mandibular direction slowly to a depth of 0.5. And the needle will be pulled out after "de qi" without being retained. For Shang Yintang, GV20 and GV24, the needle will be inserted with a 30°angle to a depth of about 0.5 cun to the subperiosteum until the patients have a strong sense that the needle is being heavily pressed. For EX-HN5 and KI 4 in both sides, the needle will be outward and obliquely inserted to the same depth of 1 cun and the needle will be manipulated with an even lifting and thrusting method to make the patients feel soreness and distention. The electric stimulator will be put on GV20, GV24 and EX-HN5 in both sides with a spare-dense wave, 10/50 Hz, 0.5-5.0 mA. The current intensity will be increased until the patients can not stand. | Procedure or surgery | Electroacupuncture combined with donepezil |
| donepezilAlso: Ariceptcholinesterase inhibitors (ChE-Is) | Drug | donepezil |
Primary outcome
change of total ADAS-cog score from baseline
Time frame: week 12 ± 3 days
The maximum score of ADAS-cog is 70 including 15 items of cognitive dysfunction assessment. The higher values indicate higher degree of deficit.
7 secondary outcomes
change of total MMSE score from baseline
Time frame: week 12 ± 3 days
change of total MMSE score from baseline
Time frame: week 36 ± 3 days
change of total ADCS-ADL score score from baseline
Time frame: week 12 ± 3 days
change of total ADCS-ADL score score from baseline
Time frame: week 36 ± 3 days
change of total QoL-AD score score from baseline
Time frame: week 12 ± 3 days
change of total QoL-AD score score from baseline
Time frame: week 36 ± 3 days
change of total ADAS-cog score from baseline
Time frame: week 36 ± 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Derived from this study: PubMed 28673322Peng W, Zhou J, Xu M, Feng Q, Bin L, Liu Z. The effect of electroacupuncture combined with donepezil on cognitive function in Alzheimer's disease patients: study protocol for a randomized controlled trial. Trials. 2017 Jul 3;18(1):301. doi: 10.1186/s13063-017-2052-y.
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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.
Weina Peng study director
Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing acupuncture and donepezil in people with Cognitive Impairment, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 May 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weina Peng (86-18610935028, wnpeng@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of total ADAS-cog score from baseline (time frame: week 12 ± 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02305836, which also lists 1 linked publication.
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 16 May 2017.