Clinical trial NCT03810794: 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
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Cognitive Impairment
Keywords: Acupuncture Treatment
Alzheimer's Disease
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Mental Health Center
name: Huashan Hospital
First posted: 2019-01-22
Enrollment: 180
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Alzheimer's Disease Assessment Scale-cognition(ADAS-cog)
timeFrame: Baseline(week -2), treatment at week 12
Secondary outcomes:
measure: Minimum Mental State Examination(MMSE)
timeFrame: Baseline(week -2), Treatment at week 12, Follow-up at weeks 12 and 24.
measure: Alzheimer's Disease Cooperative Study-Activity of Daily Living(ADCS-ADL)
timeFrame: Baseline(week -2), Treatment at week 12, Follow-up at weeks 12 and 24.
measure: Quality of Life-Alzheimer's Disease(QOL-AD)
timeFrame: Baseline(week -2), Treatment at week 12, Follow-up at weeks 12 and 24.
measure: fractional amplitude of low frequency fluctuation (fALFF)
timeFrame: Baseline(week -2), Treatment at week 12
measure: functional connectivity (FC)
timeFrame: Baseline(week -2), Treatment at week 12
Other outcomes:
Locations:
city: Shanghai
country: China
facility: LongHua Hospital Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Mental Center, Shanghai Jiaotong University of Medicial School
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
state: Shanghai
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: Jian Pei, Doctor
role: STUDY_CHAIR
affiliation: Huashan Hospital
name: Houguang Zhou, Doctor
role: STUDY_DIRECTOR
affiliation: Mental Health Center Shanghai Jiao Tong University School of Medicine
name: Tao Wang, Doctor
role: STUDY_DIRECTOR
References:
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.
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.