Cognitive DeficitsNCT04064021
Acupuncture Treatment for Improving Alzheimer's Dementia
A study testing Acupunture in people with Cognitive Deficits and Alzheimer Disease, run by N & S Neurology Center, A Medical Group, Inc.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Cognitive Deficits, Alzheimer Disease
- What is being tested?
- Acupunture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate AD
Who cannot join
- Severe AD
About this study
Official title: Clinical Trial to Measure Efficacy of Acupuncture Treatment for Alzheimer's Dementia as Measured by MOCA(Montreal Cognitive Assessment)
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.
Read the 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.
- Conditions
- Cognitive Deficits, Alzheimer Disease
- Being tested
- Acupunture
- Keywords
- Acupunture
- Medical subject headings
- Cognition Disorders, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupuntureProcedure or surgery
Patient will receive 12 acupuncture treatments over 6 weeks (2x per week)
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Acupuncture 12 sessions over 6 week to be given to pateints Receives: Procedure: Acupunture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Why it stopped: due to covid19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeficitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- N & S Neurology Center, A Medical Group, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SANJAY CHAUHAN, M.D., Principal investigator, N & S Neurology Center, A Medical Group, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064021
- Sponsor's protocol ID
- NS1
- Status last verified
- Oct 2022
- First submitted
- 28 Apr 2015
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Measure Efficacy of Acupuncture Treatment for Alzheimer's Dementia as Measured by MOCA(Montreal Cognitive Assessment)
- ClinicalTrials.gov ID
- NCT04064021
- Acronym / sponsor ID
- NS1
- Conditions
- Cognitive Deficits, Alzheimer Disease
- Keywords
- Acupunture
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: due to covid19 pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- N & S Neurology Center, A Medical Group, IncIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 21 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: AcupuntureAcupuncture 12 sessions over 6 week to be given to pateints |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mild to moderate AD
Key exclusion criteria (1 listed)
- Severe AD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunturePatient will receive 12 acupuncture treatments over 6 weeks (2x per week) | Procedure or surgery | Acupuncture |
Primary outcome
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.
1 secondary outcome
Improvement of Montreal Cognitive Assessment test by category than raw total score
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SANJAY CHAUHAN, M.D. principal investigator
N & S Neurology Center, A Medical Group, Inc
Questions about this trial
What is this clinical trial studying?
A study testing Acupunture in people with Cognitive Deficits and Alzheimer Disease, run by N & S Neurology Center, A Medical Group, Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement on Montreal Cognitive Assessment test of 5 points or more than baseline( total score is out of 30 points) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.