Ignite Creation Date:
2024-05-06 @ 12:40 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03810794
Status:
RECRUITING
Last Update Posted:
2023-12-12
First Post:
2019-01-17
Brief Title:
Clinical Evaluation on the Therapeutic Effect of Acupuncture Treatment for Alzheimers Disease
Sponsor:
Shanghai University of Traditional Chinese Medicine
Organization:
Shanghai University of Traditional Chinese Medicine
Study Overview
Official Title:
Clinical Evaluation on the Therapeutic Effect of Acupuncture Treatment for Alzheimers Disease Multicenter Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this proposed study is to evaluate the effect and safety of acupuncture combined therapy on cognitive function daily living ability and quality of life of Alzheimers disease by using the international dementia certification scale In this 12-week assessor-blind a Multi-center randomized controlled study of acupuncture as additional treatment with Donepezil a total of 180 patients with Alzheimers disease will be recruited The patients will be randomly assigned to acupuncture combined with Donepezil n 90 or Donepezil treatment n 90 36 sessions 3 sessions a week Changes in the cognition over time measured using ADAS-cog is the primary outcome MMSE ADCS-ADL and QOL-AD are the secondary outcomes The study will be conducted at LongHua Hospital Shanghai University of Traditional Chinese Medicine Huashan Hospital Fudan University and Mental Health Center Shanghai Jiao Tong University School of Medicine
Detailed Description:
Objective To evaluate the effect and safety of acupuncture combined therapy on cognitive function daily living ability and quality of life of Alzheimers disease by using the international dementia certification scale
Methodsdesign A total of 180 participants with mild to moderate Alzheimers disease will be randomly assigned to either an acupuncture combined with donepezil group or a donepezil group with a ratio of 11 Participants in the acupuncture combined with donepezil group will receive acupuncture treatment in combination with donepezil for 12 weeks and at same time taking donepezil The main acupoints are DU 24 EX-HN 3 DU 20 EX-HN 1 GB 12 HT 7 KI 6 GB39 and then selecting other acupoints according to TCM syndrome The electric stimulator will be applied to DU 24 GB 12 HT 7 and LR 3 or SP 6 with a disperse-dense wave of 250 Hz 05-10 mA There are 3 sessions per week with each session lasting for 30 min There will be 12 weeks of treatment for each participant in total Donepezil 5 mg will be given once daily before bed-time for 12 weeks After the clinical trial participants will be given conventional treatment clinically Participants in the control group will take donepezil only A follow-up will be conducted 24 weeks after the treatment The primary outcome is the change and effective rate from baseline in the ADAS-cog score measured at week 12 The secondary outcomes contains The change from baseline in MMSE score ADCS-ADL score QOL-AD score measured at weeks 12 24 and 36
Methodsdesign A total of 180 participants with mild to moderate Alzheimers disease will be randomly assigned to either an acupuncture combined with donepezil group or a donepezil group with a ratio of 11 Participants in the acupuncture combined with donepezil group will receive acupuncture treatment in combination with donepezil for 12 weeks and at same time taking donepezil The main acupoints are DU 24 EX-HN 3 DU 20 EX-HN 1 GB 12 HT 7 KI 6 GB39 and then selecting other acupoints according to TCM syndrome The electric stimulator will be applied to DU 24 GB 12 HT 7 and LR 3 or SP 6 with a disperse-dense wave of 250 Hz 05-10 mA There are 3 sessions per week with each session lasting for 30 min There will be 12 weeks of treatment for each participant in total Donepezil 5 mg will be given once daily before bed-time for 12 weeks After the clinical trial participants will be given conventional treatment clinically Participants in the control group will take donepezil only A follow-up will be conducted 24 weeks after the treatment The primary outcome is the change and effective rate from baseline in the ADAS-cog score measured at week 12 The secondary outcomes contains The change from baseline in MMSE score ADCS-ADL score QOL-AD score measured at weeks 12 24 and 36
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None