- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04064021
Acupuncture Treatment for Improving Alzheimer's Dementia
Clinical Trial to Measure Efficacy of Acupuncture Treatment for Alzheimer's Dementia as Measured by MOCA(Montreal Cognitive Assessment)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Mild to moderate AD
Exclusion Criteria:
- Severe AD
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acupuncture
Acupuncture 12 sessions over 6 week to be given to pateints
|
Patient will receive 12 acupuncture treatments over 6 weeks (2x per week)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
12 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: SANJAY CHAUHAN, M.D., N & S Neurology Center, A Medical Group, Inc
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NS1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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