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Acupuncture Treatment for Improving Alzheimer's Dementia

Primary Purpose

Cognitive Deficits, Alzheimer Disease

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupunture
Sponsored by
N & S Neurology Center, A Medical Group, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Deficits focused on measuring Acupunture

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Mild to moderate AD

Exclusion Criteria:

  • Severe AD

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Acupuncture

    Arm Description

    Acupuncture 12 sessions over 6 week to be given to pateints

    Outcomes

    Primary Outcome Measures

    Improvement on Montreal Cognitive Assessment test of 5 points or more than baseline( total score is out of 30 points)
    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

    Improvement of Montreal Cognitive Assessment test by category than raw total score
    performance on various subcategory will also be reviewed to see if one category improves over other category. (Example: Visual-spacial parameters improves over language)

    Full Information

    First Posted
    April 28, 2015
    Last Updated
    October 7, 2022
    Sponsor
    N & S Neurology Center, A Medical Group, Inc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04064021
    Brief Title
    Acupuncture Treatment for Improving Alzheimer's Dementia
    Official Title
    Clinical Trial to Measure Efficacy of Acupuncture Treatment for Alzheimer's Dementia as Measured by MOCA(Montreal Cognitive Assessment)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    due to covid19 pandemic
    Study Start Date
    January 1, 2025 (Anticipated)
    Primary Completion Date
    December 31, 2026 (Anticipated)
    Study Completion Date
    March 31, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    N & S Neurology Center, A Medical Group, Inc

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cognitive Deficits, Alzheimer Disease
    Keywords
    Acupunture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Acupuncture
    Arm Type
    Experimental
    Arm Description
    Acupuncture 12 sessions over 6 week to be given to pateints
    Intervention Type
    Procedure
    Intervention Name(s)
    Acupunture
    Intervention Description
    Patient will receive 12 acupuncture treatments over 6 weeks (2x per week)
    Primary Outcome Measure Information:
    Title
    Improvement on Montreal Cognitive Assessment test of 5 points or more than baseline( total score is out of 30 points)
    Description
    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.
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Improvement of Montreal Cognitive Assessment test by category than raw total score
    Description
    performance on various subcategory will also be reviewed to see if one category improves over other category. (Example: Visual-spacial parameters improves over language)
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Mild to moderate AD Exclusion Criteria: Severe AD
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    SANJAY CHAUHAN, M.D.
    Organizational Affiliation
    N & S Neurology Center, A Medical Group, Inc
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Acupuncture Treatment for Improving Alzheimer's Dementia

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