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Study aim
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Determining the effect of deep brain stimulation (DBS) in reducing the intensity of psychological changes, reducing drug treatment costs and improving life satisfaction of Alzheimer's patients.
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Design
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Uncontrolled clinical trial; phase 1 carried on 4 patients; and followed at 0,6 and 12 month period after the surgery
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Settings and conduct
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Surgery and data collection will be run at Imam Khomeini Hospital Center in Tehran. After being implanted in the patient's brain during the first days, the device will be turned off by the generator implanted under the patient's clavicle and will be turned on within two weeks, and the patient will visit the hospital clinic during follow up.
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Participants/Inclusion and exclusion criteria
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The study involved patients aged 45 to 80 years with functional cognitional decline and a stable cholinesterase inhibitor dose. Eligible participants had a CDR global rating of 0.5 or 1.0 and an ADAS cog 11 score of 12 to 24. Exclusion criteria included brain tumors, mental retardation, claustrophobia, metal implants, insulin-dependent diabetes, cardiovascular or neurovascular disorders, unwillingness to comply, and life expectancy less than 1 year.
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Intervention groups
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The intervention group includes Alzheimer's patients according to the mentioned protocol, during a brain surgery, the electrodes of the DBS device used will ve placed in the anterior fornix of the patients.
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Main outcome variables
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Determining and comparing the changes in MMSE and ADAS cog psychological test scores, the changes in the hippocampus volume of patients and the level of beta amyloid in the cerebrospinal fluid of patients before and after deep brain stimulation of Alzheimer's patients.