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Deep Brain Stimulation for Treatment of Severe Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT03115814
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Zhiqi Mao, Chinese PLA General Hospital

Brief Summary:
To investigate the safety of deep brain stimulation in the treatment of severe Alzheimer's disease (AD); to investigate the effectiveness of deep brain stimulation in the treatment of severe AD, i.e., effects of deep brain stimulation on cognitive function in patients with severe AD and dementia grading; to investigate the effects of deep brain stimulation on cerebral glucose metabolism in patients with severe AD.

Condition or disease
Alzheimer Disease

  Show Detailed Description

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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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
Study Population
Six Patients with severe Alzheimer's disease (AD) scheduled to receive deep brain stimulation will be all recruited from the clinics and wards of Department of Neurosurgery, Chinese PLA General Hospital of China.
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Zhiqi Mao, Ph.D 8618910155994 markmaoqi@126.com

Locations
China
Chinese PLA General Hospital Recruiting
Beijing, China, 100853
Contact: Zhiqi Mao, Ph.D    8618910155994    markmaoqi@126.com   
Principal Investigator: Zhiqi Mao, Ph.D         
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Principal Investigator: Zhiqi Mao, Ph.D Chinese PLA General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zhiqi Mao, Principal Investigator, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03115814     History of Changes
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

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders