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Progress of Mild Alzheimer's Disease in Participants on Acupuncture Versus Sham Acupuncture

Primary Purpose

Alzheimer Disease 1

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Active acupuncture
Sham acupuncture
Donepezil Hydrochloride
Sponsored by
Shanghai Institute of Acupuncture, Moxibustion and Meridian
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease 1 focused on measuring Alzheimer's Disease, Electroacupuncture

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Meets the diagnostic criteria for probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA)
  • Scored 1.0 by the Clinical Dementia Rating Scale (CDR) Global Score

Exclusion Criteria:

  • Dementia due to other causes
  • Evidence of a clinically relevant or unstable psychiatric disorder
  • Has irritable bowel syndrome or inflammatory bowel disease
  • Has unstable or severe cardiovascular, hepatic, renal, respiratory, endocrinologic, neurologic diseases and other conditions that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study
  • Has visual or hearing disorder, defeating completion of evaluation
  • Use of AD therapy (except for donepezil hydrochloride) which cannot be stopped
  • Use of antibiotics within 1 month prior to enrollment
  • Has a history of gastrointestinal surgery (except for appendicitis and hernia surgery)
  • Without a reliable caregiver who will accompany the participant during treatment and assessment, and monitor administration of the prescribed medications
  • With cardiac pacemaker or metal allergy
  • Once experienced electroacupuncture treatment before at any time (manual acupuncture is allowed)
  • Premenopausal woman

Sites / Locations

  • Shanghai Institute of Acupuncture, Moxibustion and Meridian OrganizationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active acupuncture + Donepezil

Sham acupuncture + Donepezil

Arm Description

Active acupuncture treatment is to be taken 3 sessions weekly over a period of 14 weeks. Donepezil hydrochloride (5 mg/capsule, Weicai Pharmaceutical Co., Ltd, China) is to be taken 5 mg daily over 32 weeks (including 4-week run-in) Intervention: Device: Acupuncture + Drug: Donepezil hydrochloride

Sham acupuncture treatment with no skin penetration and no current output on sham acupoints is to be taken 3 sessions weekly over a period of 14 weeks. Donepezil hydrochloride (5 mg/capsule, Weicai Pharmaceutical Co., Ltd, China) is to be taken 5 mg daily over 32 weeks (including 4-week run-in) Intervention: Device: Sham acupuncture + Drug: Donepezil hydrochloride

Outcomes

Primary Outcome Measures

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 12 Item Subscore (ADAS-Cog12)
The ADAS is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS consists of 12 items (ranges from 0 to 75). Higher scores indicating greater cognitive impairment.

Secondary Outcome Measures

Change in gut microbiota diversity based on 16S rRNA gene sequencing analysis
Stool samples will be processed to extract DNA, followed by 16S rRNA gene sequencing analysis using QIIME and R packages (v3.2.0).
Change From Baseline in Mini-Mental State Examination (MMSE)
MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges from 0 to 30; lower score indicates greater disease severity.
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL)
The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity.
Change From Baseline in Neuropsychiatric Inventory (NPI)
NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant's behavior. Total score ranges from 0 to 144, with lower scores indicating fewer behavioral disturbances
Treatment credibility
The treatment credibility scale will be assessed by asking participants to rate their response to four questions on a 5-point scale developed by Borkovec and Nau. Total score ranges from 0 to 20; higher score indicates greater treatment credibility.
Incidence of adverse events
Including subcutaneous hematoma, local errhysis at acupoints, sharp pain, palpitation, nausea, dizziness and faint during acupuncture.

Full Information

First Posted
September 23, 2021
Last Updated
April 13, 2023
Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian
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1. Study Identification

Unique Protocol Identification Number
NCT05078944
Brief Title
Progress of Mild Alzheimer's Disease in Participants on Acupuncture Versus Sham Acupuncture
Official Title
Randomized, Blinded, Sham-Controlled Trial of Acupuncture on the Progression of Mild Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine if adjunctive acupuncture acts as an AD treatment rather than a placebo, and identify if benefits are linked to shifts of the gut microbiota.
Detailed Description
Acupuncture is used as an adjuvant therapy for Alzheimer's disease (AD), but available evidence for efficacy is weak. Growing studies suggest that resident gut microbiota contributes to the development and progression of AD. Acupuncture is reported to treat gastrointestinal and neurodegenerative disorders via the gut-brain axis. The aim is to determine if adjunctive acupuncture acts as an AD treatment rather than a placebo, and identify if benefits are linked to shifts of the gut microbiota. This is a randomized, participant-masked, sham-controlled trial. One hundred and sixty participants with mild AD will be randomly assigned (1:1) to either active acupuncture or non-penetrating sham acupuncture (3 times weekly for 14 weeks) added to donepezil treatment (5 mg per day for 28 weeks). The primary efficacy outcome is the change from baseline to week 28 in the Alzheimer's disease Assessment Scale (ADAS-cog12). Secondary efficacy outcomes include other assessments of the Mini-Mental State Examination (MMSE), the Alzheimer's disease Cooperative Study-Activities of Daily Living (ADCS-ADL), Neuropsychiatric Inventory (NPI) and gut microbiota.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease 1
Keywords
Alzheimer's Disease, Electroacupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active acupuncture + Donepezil
Arm Type
Experimental
Arm Description
Active acupuncture treatment is to be taken 3 sessions weekly over a period of 14 weeks. Donepezil hydrochloride (5 mg/capsule, Weicai Pharmaceutical Co., Ltd, China) is to be taken 5 mg daily over 32 weeks (including 4-week run-in) Intervention: Device: Acupuncture + Drug: Donepezil hydrochloride
Arm Title
Sham acupuncture + Donepezil
Arm Type
Sham Comparator
Arm Description
Sham acupuncture treatment with no skin penetration and no current output on sham acupoints is to be taken 3 sessions weekly over a period of 14 weeks. Donepezil hydrochloride (5 mg/capsule, Weicai Pharmaceutical Co., Ltd, China) is to be taken 5 mg daily over 32 weeks (including 4-week run-in) Intervention: Device: Sham acupuncture + Drug: Donepezil hydrochloride
Intervention Type
Device
Intervention Name(s)
Active acupuncture
Intervention Description
Acupoints: Principal: GV20, EX-HN1, GV24 and bilateral PC6, HT7, ST36, KI3, SP6. Additional: CV6 and bilateral GB39, ST40, SP10 Sterile stainless steel disposable acupuncture needles (size 0.30 × 50 mm, Hwato brand, China) are used. After sterilization, a small plastic ring will be fixed over the acupuncture point with plaster to facilitate maintenance of blinding for the participant, and then the needle will be inserted through the plaster inside the ring. The electric stimulator (SDZ-Ⅲ electroacupuncture apparatus, Hwato brand, China) is applied to GV20, GV24, bilateral PC6 and HT7, dilatational wave, 10/50 Hz and tolerable electric current. Needles placed in other acupoints will be manually stimulated by rotation every 15 minutes. Each session lasts for 45 min.
Intervention Type
Device
Intervention Name(s)
Sham acupuncture
Intervention Description
Sham acupoints: SA1 (5 cun lateral to GV5), SA2 (5 cun lateral to GV4), SA3 (1 cun lateral to BL56). After sterilization, pragmatic placebo needles with blunt tip (size 0.30 × 50 mm, Hwato brand, China) are used. When their tips are pressed against the skin through plastic rings, participants will feel a pricking sensation. The electric stimulator is applied to bilateral SA1 and SA2 with no current output. The mental wire has been cut off with a same outlook as the electroacupuncture group. Needles placed in SA3 will be manually rotated every 15 minutes. Each session lasts for 45 min.
Intervention Type
Drug
Intervention Name(s)
Donepezil Hydrochloride
Intervention Description
Donepezil hydrochloride (5 mg/capsule, Weicai Pharmaceutical Co., Ltd, China) is to be taken 5 mg daily.
Primary Outcome Measure Information:
Title
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 12 Item Subscore (ADAS-Cog12)
Description
The ADAS is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS consists of 12 items (ranges from 0 to 75). Higher scores indicating greater cognitive impairment.
Time Frame
Baseline, Week 7, Week 14, Week 21, Week 28
Secondary Outcome Measure Information:
Title
Change in gut microbiota diversity based on 16S rRNA gene sequencing analysis
Description
Stool samples will be processed to extract DNA, followed by 16S rRNA gene sequencing analysis using QIIME and R packages (v3.2.0).
Time Frame
Baseline, Week 14, Week 28
Title
Change From Baseline in Mini-Mental State Examination (MMSE)
Description
MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges from 0 to 30; lower score indicates greater disease severity.
Time Frame
Baseline, Week 7, Week 14, Week 21, Week 28
Title
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL)
Description
The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity.
Time Frame
Baseline, Week 7, Week 14, Week 21, Week 28
Title
Change From Baseline in Neuropsychiatric Inventory (NPI)
Description
NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant's behavior. Total score ranges from 0 to 144, with lower scores indicating fewer behavioral disturbances
Time Frame
Baseline, Week 7, Week 14, Week 21, Week 28
Title
Treatment credibility
Description
The treatment credibility scale will be assessed by asking participants to rate their response to four questions on a 5-point scale developed by Borkovec and Nau. Total score ranges from 0 to 20; higher score indicates greater treatment credibility.
Time Frame
Week 1, Week 14
Title
Incidence of adverse events
Description
Including subcutaneous hematoma, local errhysis at acupoints, sharp pain, palpitation, nausea, dizziness and faint during acupuncture.
Time Frame
Week -4 to Week 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meets the diagnostic criteria for probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) Scored 1.0 by the Clinical Dementia Rating Scale (CDR) Global Score Exclusion Criteria: Dementia due to other causes Evidence of a clinically relevant or unstable psychiatric disorder Has irritable bowel syndrome or inflammatory bowel disease Has unstable or severe cardiovascular, hepatic, renal, respiratory, endocrinologic, neurologic diseases and other conditions that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study Has visual or hearing disorder, defeating completion of evaluation Use of AD therapy (except for donepezil hydrochloride) which cannot be stopped Use of antibiotics within 1 month prior to enrollment Has a history of gastrointestinal surgery (except for appendicitis and hernia surgery) Without a reliable caregiver who will accompany the participant during treatment and assessment, and monitor administration of the prescribed medications With cardiac pacemaker or metal allergy Once experienced electroacupuncture treatment before at any time (manual acupuncture is allowed) Premenopausal woman
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiehe Kong, MD
Phone
+8613621775647
Email
ynomrahkong@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaopeng Ma, MD, PhD
Organizational Affiliation
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Institute of Acupuncture, Moxibustion and Meridian Organization
City
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiehe Kong, MD
Phone
+8613621775647
Email
ynomrahkong@163.com

12. IPD Sharing Statement

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Progress of Mild Alzheimer's Disease in Participants on Acupuncture Versus Sham Acupuncture

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