Trial Outcomes & Findings for Progress of Mild Alzheimer's Disease in Participants on Acupuncture Versus Sham Acupuncture (NCT NCT05078944)
NCT ID: NCT05078944
Last Updated: 2026-05-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
160 participants
Primary outcome timeframe
Week 14
Results posted on
2026-05-22
Participant Flow
Of 192 patients screened, 160 were randomized between June 30, 2022, and January 20, 2025.
Participant milestones
| Measure |
Active Acupuncture + Donepezil
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 + Donepezil
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
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
80
|
|
Overall Study
COMPLETED
|
62
|
64
|
|
Overall Study
NOT COMPLETED
|
18
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Active Acupuncture + Donepezil
n=78 Participants
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 + Donepezil
n=79 Participants
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
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.2 year
STANDARD_DEVIATION 7.4 • n=78 Participants
|
66 year
STANDARD_DEVIATION 8 • n=79 Participants
|
67.6 year
STANDARD_DEVIATION 7.8 • n=157 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=78 Participants
|
43 Participants
n=79 Participants
|
91 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=78 Participants
|
36 Participants
n=79 Participants
|
66 Participants
n=157 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Acetylcholinesterase inhibitor or memantine use history
|
65 Participants
n=78 Participants
|
68 Participants
n=79 Participants
|
133 Participants
n=157 Participants
|
PRIMARY outcome
Timeframe: Week 14Population: Modified intention-to-treat analysis was adopted. Two in the Acive acupuncture + Donepezil group and 1 in the Sham acupuncture + Donepezil gruop were excluded from analysis due to lack of 1 valid postbasline assessment.
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.
Outcome measures
| Measure |
Active Acupuncture + Donepezil
n=78 Participants
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 + Donepezil
n=79 Participants
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
|
|---|---|---|
|
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 12 Item Subscore (ADAS-Cog12)
|
-1.20 point
Standard Error 0.31
|
0.36 point
Standard Error 0.32
|
SECONDARY outcome
Timeframe: Baseline, Week 7, Week 14, Week 21, Week 28MMSE 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 7, Week 14, Week 21, Week 28The 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 7, Week 14, Week 21, Week 28NPI 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 1, Week 14The 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week -4 to Week 28Including subcutaneous hematoma, local errhysis at acupoints, sharp pain, palpitation, nausea, dizziness and faint during acupuncture.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 14, Week 28Stool samples will be processed to extract DNA, followed by 16S rRNA gene sequencing analysis using QIIME and R packages (v3.2.0).
Outcome measures
Outcome data not reported
Adverse Events
Active Acupuncture + Donepezil
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Sham Acupuncture + Donepezil
Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Acupuncture + Donepezil
n=78 participants at risk
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 + Donepezil
n=79 participants at risk
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
|
|---|---|---|
|
Vascular disorders
Cerebrovascular accident
|
0.00%
0/78 • from enrollment until end of follow-up, up to 28 weeks
Modified intention-to-treat analysis was adopted. Two in the Acive acupuncture + Donepezil group and 1 in the Sham acupuncture + Donepezil gruop were excluded from analysis due to lack of 1 valid postbasline assessment.
|
1.3%
1/79 • from enrollment until end of follow-up, up to 28 weeks
Modified intention-to-treat analysis was adopted. Two in the Acive acupuncture + Donepezil group and 1 in the Sham acupuncture + Donepezil gruop were excluded from analysis due to lack of 1 valid postbasline assessment.
|
Other adverse events
| Measure |
Active Acupuncture + Donepezil
n=78 participants at risk
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 + Donepezil
n=79 participants at risk
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
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
3.8%
3/78 • from enrollment until end of follow-up, up to 28 weeks
Modified intention-to-treat analysis was adopted. Two in the Acive acupuncture + Donepezil group and 1 in the Sham acupuncture + Donepezil gruop were excluded from analysis due to lack of 1 valid postbasline assessment.
|
3.8%
3/79 • from enrollment until end of follow-up, up to 28 weeks
Modified intention-to-treat analysis was adopted. Two in the Acive acupuncture + Donepezil group and 1 in the Sham acupuncture + Donepezil gruop were excluded from analysis due to lack of 1 valid postbasline assessment.
|
|
General disorders
Headache
|
2.6%
2/78 • from enrollment until end of follow-up, up to 28 weeks
Modified intention-to-treat analysis was adopted. Two in the Acive acupuncture + Donepezil group and 1 in the Sham acupuncture + Donepezil gruop were excluded from analysis due to lack of 1 valid postbasline assessment.
|
5.1%
4/79 • from enrollment until end of follow-up, up to 28 weeks
Modified intention-to-treat analysis was adopted. Two in the Acive acupuncture + Donepezil group and 1 in the Sham acupuncture + Donepezil gruop were excluded from analysis due to lack of 1 valid postbasline assessment.
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/78 • from enrollment until end of follow-up, up to 28 weeks
Modified intention-to-treat analysis was adopted. Two in the Acive acupuncture + Donepezil group and 1 in the Sham acupuncture + Donepezil gruop were excluded from analysis due to lack of 1 valid postbasline assessment.
|
3.8%
3/79 • from enrollment until end of follow-up, up to 28 weeks
Modified intention-to-treat analysis was adopted. Two in the Acive acupuncture + Donepezil group and 1 in the Sham acupuncture + Donepezil gruop were excluded from analysis due to lack of 1 valid postbasline assessment.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous hematoma
|
5.1%
4/78 • from enrollment until end of follow-up, up to 28 weeks
Modified intention-to-treat analysis was adopted. Two in the Acive acupuncture + Donepezil group and 1 in the Sham acupuncture + Donepezil gruop were excluded from analysis due to lack of 1 valid postbasline assessment.
|
0.00%
0/79 • from enrollment until end of follow-up, up to 28 weeks
Modified intention-to-treat analysis was adopted. Two in the Acive acupuncture + Donepezil group and 1 in the Sham acupuncture + Donepezil gruop were excluded from analysis due to lack of 1 valid postbasline assessment.
|
|
General disorders
Fatigue
|
2.6%
2/78 • from enrollment until end of follow-up, up to 28 weeks
Modified intention-to-treat analysis was adopted. Two in the Acive acupuncture + Donepezil group and 1 in the Sham acupuncture + Donepezil gruop were excluded from analysis due to lack of 1 valid postbasline assessment.
|
1.3%
1/79 • from enrollment until end of follow-up, up to 28 weeks
Modified intention-to-treat analysis was adopted. Two in the Acive acupuncture + Donepezil group and 1 in the Sham acupuncture + Donepezil gruop were excluded from analysis due to lack of 1 valid postbasline assessment.
|
|
Cardiac disorders
Heart palpitations
|
1.3%
1/78 • from enrollment until end of follow-up, up to 28 weeks
Modified intention-to-treat analysis was adopted. Two in the Acive acupuncture + Donepezil group and 1 in the Sham acupuncture + Donepezil gruop were excluded from analysis due to lack of 1 valid postbasline assessment.
|
0.00%
0/79 • from enrollment until end of follow-up, up to 28 weeks
Modified intention-to-treat analysis was adopted. Two in the Acive acupuncture + Donepezil group and 1 in the Sham acupuncture + Donepezil gruop were excluded from analysis due to lack of 1 valid postbasline assessment.
|
|
General disorders
Dizziness
|
0.00%
0/78 • from enrollment until end of follow-up, up to 28 weeks
Modified intention-to-treat analysis was adopted. Two in the Acive acupuncture + Donepezil group and 1 in the Sham acupuncture + Donepezil gruop were excluded from analysis due to lack of 1 valid postbasline assessment.
|
2.5%
2/79 • from enrollment until end of follow-up, up to 28 weeks
Modified intention-to-treat analysis was adopted. Two in the Acive acupuncture + Donepezil group and 1 in the Sham acupuncture + Donepezil gruop were excluded from analysis due to lack of 1 valid postbasline assessment.
|
|
Renal and urinary disorders
Urinary tract infection
|
3.8%
3/78 • from enrollment until end of follow-up, up to 28 weeks
Modified intention-to-treat analysis was adopted. Two in the Acive acupuncture + Donepezil group and 1 in the Sham acupuncture + Donepezil gruop were excluded from analysis due to lack of 1 valid postbasline assessment.
|
5.1%
4/79 • from enrollment until end of follow-up, up to 28 weeks
Modified intention-to-treat analysis was adopted. Two in the Acive acupuncture + Donepezil group and 1 in the Sham acupuncture + Donepezil gruop were excluded from analysis due to lack of 1 valid postbasline assessment.
|
|
Gastrointestinal disorders
Diarrhea
|
2.6%
2/78 • from enrollment until end of follow-up, up to 28 weeks
Modified intention-to-treat analysis was adopted. Two in the Acive acupuncture + Donepezil group and 1 in the Sham acupuncture + Donepezil gruop were excluded from analysis due to lack of 1 valid postbasline assessment.
|
6.3%
5/79 • from enrollment until end of follow-up, up to 28 weeks
Modified intention-to-treat analysis was adopted. Two in the Acive acupuncture + Donepezil group and 1 in the Sham acupuncture + Donepezil gruop were excluded from analysis due to lack of 1 valid postbasline assessment.
|
|
Infections and infestations
COVID-19
|
14.1%
11/78 • from enrollment until end of follow-up, up to 28 weeks
Modified intention-to-treat analysis was adopted. Two in the Acive acupuncture + Donepezil group and 1 in the Sham acupuncture + Donepezil gruop were excluded from analysis due to lack of 1 valid postbasline assessment.
|
17.7%
14/79 • from enrollment until end of follow-up, up to 28 weeks
Modified intention-to-treat analysis was adopted. Two in the Acive acupuncture + Donepezil group and 1 in the Sham acupuncture + Donepezil gruop were excluded from analysis due to lack of 1 valid postbasline assessment.
|
Additional Information
Xiaopeng Ma
Shanghai Research Institute of Acupuncture and Meridian
Phone: 02164690257
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place