Deep Brain Stimulation for Treatment of Severe Alzheimer's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03115814|
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : July 2, 2017
|Condition or disease|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||6 participants|
|Official Title:||Deep Brain Stimulation for Treatment of Severe Alzheimer's Disease: Study Protocol of a Prospective, Self-control Phase I Trial|
|Actual Study Start Date :||April 17, 2017|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||June 2019|
- Deep brain stimulation-related disability rates [ Time Frame: changes of baseline and month 1, month 6, month 12 after surgery ]To assess the effectiveness of deep brain stimulation in the treatment of Alzheimer's disease (AD).
- Clinical Dementia Rating(CDR) score [ Time Frame: changes of baseline and month 1, month 6, month 12 after surgery ]The Clinical Dementia Rating(CDR) is 5-point scale used to characterize six domains (memory, orientation, judgment & problem solving, community affairs, home & hobbies and personal care) of the cognitive and functional performance of the aged (in particular AD patients). Patients are rated on dementia severity: 0 = normal, 0.5 = questionable dementia; 1 = mild dementia; 2 = moderate dementia; 3 = severe dementia.
- The Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-Cog) [ Time Frame: changes of baseline and month 1, month 6, month 12 after surgery ]The Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-Cog) scale is widely used for evaluating the severity of AD. ADAS-Cog consists of 12 components including word recall, naming, command, constructional praxis, ideational praxis, orientation, word recognition, remembering test instructions, spoken language ability, word finding difficulty, comprehension of oral language, and attention. The ADAS-Cog assesses multiple cognitive domains including memory, language, praxis, and orientation. ADAS-Cog score ranges from 0-75, with higher scores indicating more severe cognitive impairment.
- Mini-Mental State Examination (MMSE) score [ Time Frame: changes of baseline and month 1, month 6, month 12 after surgery ]Mini-Mental State Examination (MMSE) is one of the most influential cognitive screening tools worldwide. It consists of five dimensions including orientation (10 points), registration (3 points), attention and calculation (5 points), recall (3 points) and language and praxis (9 points). Educational attainment level-related dementia classification: illiterate: 5 points ≤ MMSE score ≤16 points; primary school: 8 points ≤ MMSE score ≤ 20 points; junior high school and above: 10 points ≤ MMSE score ≤ 24 points.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115814
|Contact: Zhiqi Mao, Ph.Dfirstname.lastname@example.org|
|Chinese PLA General Hospital||Recruiting|
|Beijing, China, 100853|
|Contact: Zhiqi Mao, Ph.D 8618910155994 email@example.com|
|Principal Investigator: Zhiqi Mao, Ph.D|
|Principal Investigator:||Zhiqi Mao, Ph.D||Chinese PLA General Hospital|