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Acupuncture Treatment for Improving Alzheimer's Dementia

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: NCT04064021
Recruitment Status : Not yet recruiting
First Posted : August 21, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
N & S Neurology Center, A Medical Group, Inc

Brief Summary:
Evaluate cognitive improvement pre amd post acupuncture treatment in patients with probable alzheimer's dementia as measured by MOCA score and also per form A( measure of patient's personal information). Also caregiver input.

Condition or disease Intervention/treatment Phase
Cognitive Deficits Alzheimer Disease Procedure: Acupunture Not Applicable

Detailed Description:

Patient's with diagnosis of probable mild to moderate AD will be enrolled in this study. Patient will undergo neurological examination including MOCA. Examiner will also fill out Form A at the time of initial evaluation.

Patient will then undergo series of acupuncture treatments 2 per week for 6 weeks(12 acupuncture treatment). At end of this intervention patients will be reassessed using same testing(MOCA and form A) Data collected will be assessed via statistical analysis to see if there is any statistically significant improvement.

Acupuncture points used in this trial will stay the same for all subjects and throughout the course. The points will be Si Shen Chong, ST36, 37, LV 2,3,6, GB 34, 39, Xia San Huang, LI 11, LI 4.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial to Measure Efficacy of Acupuncture Treatment for Alzheimer's Dementia as Measured by MOCA(Montreal Cognitive Assessment)
Estimated Study Start Date : June 30, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021


Arm Intervention/treatment
Experimental: Acupuncture
Acupuncture 12 sessions over 6 week to be given to pateints
Procedure: Acupunture
Patient will receive 12 acupuncture treatments over 6 weeks (2x per week)




Primary Outcome Measures :
  1. Improvement on Montreal Cognitive Assessment test of 5 points or more than baseline( total score is out of 30 points) [ Time Frame: 12 weeks ]

    Subject will complete 3 MOCA assessment prior to study over 1 week time. Best score of three is used.

    After study is complete subject will also undergo 3 MOCA assessment over 1 week immediately after study. Again best score is used.



Secondary Outcome Measures :
  1. Improvement of Montreal Cognitive Assessment test by category than raw total score [ Time Frame: 12 weeks ]
    performance on various subcategory will also be reviewed to see if one category improves over other category. (Example: Visual-spacial parameters improves over language)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild to moderate AD

Exclusion Criteria:

  • Severe AD

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): NCT04064021


Contacts
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Contact: SANJAY CHAUHAN, M.D. 559-244-0955 schauhan@sanjaychauhanmdinc.com
Contact: Julia Su 559-244-0955

Sponsors and Collaborators
N & S Neurology Center, A Medical Group, Inc
Investigators
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Principal Investigator: SANJAY CHAUHAN, M.D. N & S Neurology Center, A Medical Group, Inc
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Responsible Party: N & S Neurology Center, A Medical Group, Inc
ClinicalTrials.gov Identifier: NCT04064021    
Other Study ID Numbers: NS1
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by N & S Neurology Center, A Medical Group, Inc:
Acupunture
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Cognition Disorders
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders