Deep Brain Stimulation for Treatment of Severe Alzheimer's Disease
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ClinicalTrials.gov Identifier: NCT03115814 |
Recruitment Status : Unknown
Verified June 2017 by Zhiqi Mao, Chinese PLA General Hospital.
Recruitment status was: Recruiting
First Posted : April 14, 2017
Last Update Posted : July 2, 2017
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Condition or disease |
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Alzheimer Disease |

Study Type : | Observational |
Estimated Enrollment : | 6 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
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.

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Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Meet the diagnosis criteria of AD formulated by the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA);
- MMSE score 0-10 points;
- Age 40-80 years;
- Provision of signed informed consent.
Exclusion Criteria:
- Abnormal brain structure prior to surgery (tumor, cerebral infarction, intracranial hematoma)
- Complicated by other neurological system disorders, such as multiple sclerosis and epilepsy;
- Psychiatric disorders, such as anxiety, depression or drug-induced psychosis;
- Severe internal diseases, are taking respiratory system drugs, cardiovascular drugs, anticonvulsants or psychotropic drugs;
- Inability to tolerance clinical complications;
- Severe auditory and visual disorders.

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.D | 8618910155994 | markmaoqi@126.com |
China | |
Chinese PLA General Hospital | Recruiting |
Beijing, China, 100853 | |
Contact: Zhiqi Mao, Ph.D 8618910155994 markmaoqi@126.com | |
Principal Investigator: Zhiqi Mao, Ph.D |
Principal Investigator: | Zhiqi Mao, Ph.D | Chinese PLA General Hospital |
Responsible Party: | Zhiqi Mao, Principal Investigator, Chinese PLA General Hospital |
ClinicalTrials.gov Identifier: | NCT03115814 |
Other Study ID Numbers: |
ChinaPLAGH_MZQ |
First Posted: | April 14, 2017 Key Record Dates |
Last Update Posted: | July 2, 2017 |
Last Verified: | June 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |