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Clinical Evaluation on the Therapeutic Effect of Acupuncture Treatment for Alzheimer's Disease

Primary Purpose

Alzheimer Disease, Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Acupuncture
Donepezil
Sponsored by
Shanghai University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Acupuncture Treatment, Alzheimer's Disease

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • aged between 50-85 years
  • the diagnostic criteria of Neurological Communicative Disorders and Stroke and the Alzheimer Disease and Related Disorders Association (NINCDS-ADRDA)
  • cognitive impairment based on the scores of the Chinese version of the Mini Mental State Examination (MMSE) (patients with mild to moderate Alzheimers disease, 11≤primary school degree≤22, 11≤junior high school degree or above≤26
  • magnetic resonance imaging (MRI) confirmation of atrophy of the hippocampus or the medial temporal lobe volume, MRI manifestation of high possibility of Alzheimer Disease
  • the Medial Temporal Lobe Atrophy Rating Scale (MTA-scale) score (≥2 for those under 75 years, and ≥3 for those over 75 years)
  • voluntarily joining this study with informed consents

Exclusion Criteria:

  • cognitive impairment caused by other factors (e.g. vascular dementia, dementia with Lewy 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))
  • a serious heart condition, hepatic disease, renal system disease, hematopoietic system disease, or whole-body malnutrition
  • aphasia, disturbance of consciousness, or failure to cooperate with the related examinations due to physical disability
  • anticoagulant treatments such as warfarin or heparin
  • use of pacemakers or receiving acupuncture in the past 2 weeks

Sites / Locations

  • LongHua Hospital Shanghai University of Traditional Chinese MedicineRecruiting
  • Shanghai Mental Center, Shanghai Jiaotong University of Medicial SchoolRecruiting
  • Huashan Hospital Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acupuncture Treatment Group

Donepezil Group

Arm Description

Participants in this group will be given acupuncture treatment in combination with donepezil for 12 weeks.

Participants in this group will be given only donepezil for 12 weeks.

Outcomes

Primary Outcome Measures

Alzheimer's Disease Assessment Scale-cognition(ADAS-cog)
The primary outcome are the change and effective rate from baseline in the Alzheimer's Disease Assessment Scale-cognition(ADAS-cog) score measured at week 12. The maximum score of the ADAS-cog is 70 including 12 items. The questions in this scale contain word recall task, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition task, remembering test directions, spoken language, word-finding difficulty, comprehension and attention. In general, a normal score for someone who does not have AD or another type of dementia is 5. The higher scores indicate higher degree of cognitive dysfunction.

Secondary Outcome Measures

Minimum Mental State Examination(MMSE)
The change from baseline in total Minimum Mental State Examination(MMSE) score should be measured at weeks 12, 24 and 36. The maximum score of the MMSE is 30. The questions in this scale include orientation to time, orientation to place, attention and calculation, recall of three words, and visual construction. The lower scores indicate higher degree of cognitive dysfunction. The score is related to degree of education. In general, the score of normal people is 27-30.
Alzheimer's Disease Cooperative Study-Activity of Daily Living(ADCS-ADL)
The change from baseline in the Alzheimer's Disease Cooperative Study-Activity of Daily Living(ADCS-ADL) score should be measured at weeks 12, 24 and 36. The maximum of the ADCS-ADL score is 54 containing 19 domains about assessment of basic and operational ability of daily living. The higher scores indicate higher ability of daily living.
Quality of Life-Alzheimer's Disease(QOL-AD)
The change from baseline in the Quality of Life-Alzheimer's Disease(QOL-AD) score should be measured at weeks 12, 24 and 36. The QOL-AD score includes 13 items about physical health, mental health, social and financial assessment, and quality of life. The total score ranges from 13 to 52. The higher scores indicate higher quality of life.
fractional amplitude of low frequency fluctuation (fALFF)
fALFF aquired by fMRI technique measures the relative contribution of low frequency fluctuations within a specific frequency band to the whole detectable frequency range
functional connectivity (FC)
FC aquired by fMRI technique measures the functional connectivity of specific brain regions to the whole brain

Full Information

First Posted
January 17, 2019
Last Updated
July 23, 2022
Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Shanghai Mental Health Center, Huashan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03810794
Brief Title
Clinical Evaluation on the Therapeutic Effect of Acupuncture Treatment for Alzheimer's Disease
Official Title
Clinical Evaluation on the Therapeutic Effect of Acupuncture Treatment for Alzheimer's Disease: Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Shanghai Mental Health Center, Huashan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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 Alzheimer's 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 Alzheimer's 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 Alzheimer's disease by using the international dementia certification scale. Methods/design: A total of 180 participants with mild to moderate Alzheimer's disease will be randomly assigned to either an acupuncture combined with donepezil group or a donepezil group with a ratio of 1:1. 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 2/50 Hz, 0.5-1.0 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Cognitive Impairment
Keywords
Acupuncture Treatment, Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture Treatment Group
Arm Type
Experimental
Arm Description
Participants in this group will be given acupuncture treatment in combination with donepezil for 12 weeks.
Arm Title
Donepezil Group
Arm Type
Active Comparator
Arm Description
Participants in this group will be given only donepezil for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
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 2/50 Hz, 0.5-1.0 mA. There are three sessions per week with each session lasting for 30 min. There will be 12 weeks of treatment for each participant in total.
Intervention Type
Drug
Intervention Name(s)
Donepezil
Other Intervention Name(s)
Donepezil Hydrochloride Tablets
Intervention Description
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.
Primary Outcome Measure Information:
Title
Alzheimer's Disease Assessment Scale-cognition(ADAS-cog)
Description
The primary outcome are the change and effective rate from baseline in the Alzheimer's Disease Assessment Scale-cognition(ADAS-cog) score measured at week 12. The maximum score of the ADAS-cog is 70 including 12 items. The questions in this scale contain word recall task, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition task, remembering test directions, spoken language, word-finding difficulty, comprehension and attention. In general, a normal score for someone who does not have AD or another type of dementia is 5. The higher scores indicate higher degree of cognitive dysfunction.
Time Frame
Baseline(week -2), treatment at week 12
Secondary Outcome Measure Information:
Title
Minimum Mental State Examination(MMSE)
Description
The change from baseline in total Minimum Mental State Examination(MMSE) score should be measured at weeks 12, 24 and 36. The maximum score of the MMSE is 30. The questions in this scale include orientation to time, orientation to place, attention and calculation, recall of three words, and visual construction. The lower scores indicate higher degree of cognitive dysfunction. The score is related to degree of education. In general, the score of normal people is 27-30.
Time Frame
Baseline(week -2), Treatment at week 12, Follow-up at weeks 12 and 24.
Title
Alzheimer's Disease Cooperative Study-Activity of Daily Living(ADCS-ADL)
Description
The change from baseline in the Alzheimer's Disease Cooperative Study-Activity of Daily Living(ADCS-ADL) score should be measured at weeks 12, 24 and 36. The maximum of the ADCS-ADL score is 54 containing 19 domains about assessment of basic and operational ability of daily living. The higher scores indicate higher ability of daily living.
Time Frame
Baseline(week -2), Treatment at week 12, Follow-up at weeks 12 and 24.
Title
Quality of Life-Alzheimer's Disease(QOL-AD)
Description
The change from baseline in the Quality of Life-Alzheimer's Disease(QOL-AD) score should be measured at weeks 12, 24 and 36. The QOL-AD score includes 13 items about physical health, mental health, social and financial assessment, and quality of life. The total score ranges from 13 to 52. The higher scores indicate higher quality of life.
Time Frame
Baseline(week -2), Treatment at week 12, Follow-up at weeks 12 and 24.
Title
fractional amplitude of low frequency fluctuation (fALFF)
Description
fALFF aquired by fMRI technique measures the relative contribution of low frequency fluctuations within a specific frequency band to the whole detectable frequency range
Time Frame
Baseline(week -2), Treatment at week 12
Title
functional connectivity (FC)
Description
FC aquired by fMRI technique measures the functional connectivity of specific brain regions to the whole brain
Time Frame
Baseline(week -2), Treatment at week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: aged between 50-85 years the diagnostic criteria of Neurological Communicative Disorders and Stroke and the Alzheimer Disease and Related Disorders Association (NINCDS-ADRDA) cognitive impairment based on the scores of the Chinese version of the Mini Mental State Examination (MMSE) (patients with mild to moderate Alzheimers disease, 11≤primary school degree≤22, 11≤junior high school degree or above≤26 magnetic resonance imaging (MRI) confirmation of atrophy of the hippocampus or the medial temporal lobe volume, MRI manifestation of high possibility of Alzheimer Disease the Medial Temporal Lobe Atrophy Rating Scale (MTA-scale) score (≥2 for those under 75 years, and ≥3 for those over 75 years) voluntarily joining this study with informed consents Exclusion Criteria: cognitive impairment caused by other factors (e.g. vascular dementia, dementia with Lewy 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)) a serious heart condition, hepatic disease, renal system disease, hematopoietic system disease, or whole-body malnutrition aphasia, disturbance of consciousness, or failure to cooperate with the related examinations due to physical disability anticoagulant treatments such as warfarin or heparin use of pacemakers or receiving acupuncture in the past 2 weeks
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Pei, Doctor
Phone
00862164385700
Ext
3534
Email
jianpei99@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Pei, Doctor
Organizational Affiliation
Shanghai University of Traditional Chinese Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Houguang Zhou, Doctor
Organizational Affiliation
Huashan Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tao Wang, Doctor
Organizational Affiliation
Mental Health Center Shanghai Jiao Tong University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
LongHua Hospital Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Pei, Doctor
Phone
00862164385700
Ext
3534
Email
jianpei99@hotmail.com
Facility Name
Shanghai Mental Center, Shanghai Jiaotong University of Medicial School
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Wang, Doctor
Phone
00862163846590
Facility Name
Huashan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Houguang Zhou, Doctor

12. IPD Sharing Statement

Citations:
PubMed Identifier
35986297
Citation
Fu QH, Pei J, Zhou HG, Wang T, Zhan YJ, Tao L, Xu J, Zhou Q, Wang LY. Effect of acupuncture with donepezil based on syndrome differentiation on cognitive function in patients with mild-to-moderate Alzheimer's disease: a study protocol for a multicenter randomized controlled trial. Trials. 2022 Aug 19;23(1):695. doi: 10.1186/s13063-022-06532-1.
Results Reference
derived
PubMed Identifier
35899271
Citation
Zhan Y, Fu Q, Pei J, Fan M, Yu Q, Guo M, Zhou H, Wang T, Wang L, Chen Y. Modulation of Brain Activity and Functional Connectivity by Acupuncture Combined With Donepezil on Mild-to-Moderate Alzheimer's Disease: A Neuroimaging Pilot Study. Front Neurol. 2022 Jul 11;13:912923. doi: 10.3389/fneur.2022.912923. eCollection 2022.
Results Reference
derived

Learn more about this trial

Clinical Evaluation on the Therapeutic Effect of Acupuncture Treatment for Alzheimer's Disease

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