Status:
UNKNOWN
Effect of Electroacupuncture Combined With Donepezil for Treating Alzheimer's Disease
Lead Sponsor:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Conditions:
Cognitive Impairment
Eligibility:
All Genders
60-85 years
Phase:
PHASE2
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. Th...
Detailed Description
* Patient registry: Participants experiencing cognitive impairment will be recruited will be recruited at Guang'anmen Hospital, Beijing, China, via web or posters. A neurologist will make the diagnosi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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).
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
334 Patients enrolled
Trial Details
Trial ID
NCT02305836
Start Date
June 1 2017
End Date
December 1 2019
Last Update
May 16 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
Beijing, China, 100053