Effect of Electroacupuncture Combined With Donepezil for Treating Alzheimer's Disease

NCT02305836 | Unknown Phase 2 DMC

• 1 other identifier: 2014S291
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective randomized controlled trial aimed at assessing if electroacupuncture (EA) combined with donepezil is more effective than donepezil for improving the cognitive function of AD patients. The hypothesis of this study is as follow:

• Is the short-term effect of EA combined with donepezil better than donepezil on improving cognitive function of patients with Alzheimer's disease after 12 weeks' treatment?
• Whether the effect of EA combined with donepezil on improving cognitive function can last until the end of 6 months' follow-up?

Conditions

Cognitive Impairment

Keywords

Electroacupuncture; Donepezil; Alzheimer's disease; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• change of total ADAS-cog score from baseline

  The maximum score of ADAS-cog is 70 including 15 items of cognitive dysfunction assessment. The higher values indicate higher degree of deficit.

  week 12 ± 3 days

Secondary Outcomes (7)

• change of total MMSE score from baseline

  week 12 ± 3 days

• change of total MMSE score from baseline

  week 36 ± 3 days

• change of total ADCS-ADL score score from baseline

  week 12 ± 3 days

• change of total ADCS-ADL score score from baseline

  week 36 ± 3 days

• change of total QoL-AD score score from baseline

  week 12 ± 3 days

Other Outcomes (2)

• Safety related evaluation of electroacupuncture as measured by number of participants with adverse events.

  from week 1 up to week 12

• Safety related evaluation of Donepezil as measured by number of participants with adverse events.

  from week 1 up to week 36

Study Arms (2)

Electroacupuncture combined with donepezil

EXPERIMENTAL

Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).

Procedure: acupuncture

donepezil

ACTIVE COMPARATOR

Donepezil will be given once daily before bed-time for the first 4-6 weeks. Based on the treatment effect, the dosage may be increased to 10 mg once daily before bed-time for the next 6-8 weeks. Donepezil will be taken for continuous 24 weeks. The full course of treatment is 36 weeks.

Drug: donepezil

Interventions

acupuncture PROCEDURE

For GV16, the needle in length of 25mm will be inserted obliquely and downward towards mandibular direction slowly to a depth of 0.5. And the needle will be pulled out after "de qi" without being retained. For Shang Yintang, GV20 and GV24, the needle will be inserted with a 30°angle to a depth of about 0.5 cun to the subperiosteum until the patients have a strong sense that the needle is being heavily pressed. For EX-HN5 and KI 4 in both sides, the needle will be outward and obliquely inserted to the same depth of 1 cun and the needle will be manipulated with an even lifting and thrusting method to make the patients feel soreness and distention. The electric stimulator will be put on GV20, GV24 and EX-HN5 in both sides with a spare-dense wave, 10/50 Hz, 0.5-5.0 mA. The current intensity will be increased until the patients can not stand.

Also known as: electroacupuncture

Electroacupuncture combined with donepezil

donepezil DRUG

cholinesterase inhibitors (ChE-Is)

Also known as: Aricept

donepezil

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants meeting all of the following criteria will be included in this trial: 1) the diagnostic criteria of Neurological Communicative Disorders and Stroke and the Alzheimer Disease and Related Disorders Association (NINCDS-ADRDA) or the Operational Criteria for the Diagnosis of Alzheimer's disease (OCDAD), 2) aged between 60-85 years, 3) cognitive impairment based on the scores of the Chinese version of the Mini Mental State Examination (MMSE) (illiteracy group ≤19, primary school group ≤22, junior high school and high school group ≤23, and well-educated group ≤26), 4) absence of depression (via an emotional assessment), 5) Magnetic Resonance Imaging (MRI) confirmation of atrophy of the hippocampus or the medial temporal lobe volume, 6) the Medial Temporal Lobe Atrophy Rating Scale (MTA-scale) score (≥ 2 for those under 75 years, and ≥ 3 for those over 75 years).

You may not qualify if:

• Participants meeting any one of the following criteria will be excluded from this trial: 1) Cognitive impairment caused by other factors (e.g. vascular dementia, dementia with Lewy's bodies, frontotemporal dementia, hormone or metabolic abnormalities, hypothyroidism, folic acid or vitamin B12 deficiency, delirium or other mental and emotional disorders \[such as schizophrenia and depression\]), 2) a serious heart condition, hepatic disease, renal system disease, hematopoietic system disease, or malnutrition of the whole body, 3) aphasia or decreased vision that is severe, blindness, disturbance of consciousness, or participants who cannot cooperate with the related examinations due to physical disability, 4) anticoagulant treatments such as warfarin or heparin, 5) use of pacemakers or participants too afraid of acupuncture, or 6) acupuncture or donepezil treatment in the past 30 days.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences

Beijing, 100053, China

RECRUITING

Related Publications (1)

• Peng W, Zhou J, Xu M, Feng Q, Bin L, Liu Z. The effect of electroacupuncture combined with donepezil on cognitive function in Alzheimer's disease patients: study protocol for a randomized controlled trial. Trials. 2017 Jul 3;18(1):301. doi: 10.1186/s13063-017-2052-y.

  PMID: 28673322 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Interventions

Acupuncture Therapy; Electroacupuncture; Donepezil

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Combined Modality Therapy; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia; Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Weina Peng

  Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

Weina Peng

CONTACT

86-18610935028; wnpeng@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of Acupuncture Department of Guangan'men Hospital

Study Record Dates

• First Submitted: November 13, 2014
• First Posted: December 3, 2014
• Study Start: June 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 16, 2017

Record last verified: 2017-05

Locations

CN (1)