Mild Cognitive ImpairmentNCT03404765
Effects of Tai Chi on Cognition, I-ADLs, and HRQOL in Older People With MCI
A study testing Tai Chi in people with Mild Cognitive Impairment, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The prevalence of older people with cognitive decline is increasing since the aging population is growing substantially worldwide. Cognitive impairment places older adults at high risk for functional disability. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Tai Chi
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Dec 2015to 1 Sep 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chinese people aged 60 years or above;
- Obtained the CMMSE screening score ranging from 19 to 28, which was corrected based on educational level (≥ 18 for illiterate respondents and ≥ 22 for those having received more than two years of education);
- Have ability to perform self-care functions on their own;
- No confirmed diagnosis of dementia, depression or other psychiatric illnesses;
- Not engaged in any structured physical exercise program or Tai Chi practice in the preceding year.
Who cannot join
- Had a medical history of chronic alcoholism or brain trauma occurred in previous years; - Regular users of medications that could affect cognition;
- Contraindicated light to moderate physical exercise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Tai Chi on Cognition and Instrumental Activities of Daily Living, and Health Related Quality of Life in Older People With Mild Cognitive Impairment .
The prevalence of older people with cognitive decline is increasing since the aging population is growing substantially worldwide. Cognitive impairment places older adults at high risk for functional disability. Previous researches have provided strong evidence on the beneficial effects of physical exercise on maintaining cognitive functions in older adults. Tai Chi is considered as a low to moderate intensity exercise, which is performed in a slow and rhythmic movement. It is a popular and safe exercise suitable for older people who have weaker muscle strength. The aim of this study was to determine the effects of Tai Chi on cognition and instrumental activities of daily living (I-ADLs), and health-related quality of life (HRQOL) in older Chinese adults with mild cognitive impairment (MCI).
The research hypothesis of the study stated: There is significant improvement in the general cognitive performance, functional capabilities of instrumental ADLs,the physical component and mental component of HRQOL between the group of community-dwelling older people with MCI who have participated and the control group who have not participated in the Tai Chi program.
Read the detailed description
- Study design \& sample recruitment: This was a quasi-experimental study which adopted the multi-site non-randomized control group pre- and post-test design. By adopting the multi-site design, better representation of the population could be obtained. This intervention study involved two groups of participant, the experimental and control groups, whereas no randomization would be taken place. The study was carried out in District Elderly Community Centers (DECCs) in Hong Kong. The DECC has been implemented since 2001 under the support from the Social Warfare Department (SWD) to provide community support services at district level to enable older people to remain in the community and to lead a healthy, respectful and dignified life.The service users are community-dwelling older citizens aged 60 or above living in the locality. Invitation letters were sent to various DECCs for joining the study. Finally, there were four elderly centers willing to participate in the study. The participants were recruited from the four DECCs using convenience sampling. To avoid the possible diffusion effect that might interfere the research result, all eligible participants in a community center were allocated to either experimental group or control group, who were treated with single intervention, so there would be no discussion among participants who have received different treatment regimes. The present study had employed a control group to enhance methodological rigor and included a pre-test to assess the equivalence between two groups, so the problem on selection biases could be alleviated.
- Sample size estimation A medium effect size of 0.5 was set for the study, based on previous research on the effect of Tai Chi on cognitive function. Based on the use of a sample size calculator (https://www2.ccrb.cuhk.edu.hk/stat/Other.htm), a sample of 64 per group was expected to provide 80% power to detect a medium effect size of 0.5, at a significance level of 0.05. Allowing for an attrition rate of 20% in the Tai Chi groups, 80 participants were recruited for each group.
- Intervention The intervention group received a 16-week Tai Chi program, of 32 sessions (two sessions per week) each one hour long.The capacity was around 20 people per class. A certified Tai Chi master taught the Yang-style simple form of Tai Chi to the participants allocated to the experimental group.There were four sets of movements included in the simplified form; this required less time for the older practitioners, who usually had less exercise endurance, to complete the whole set of movements. Moreover, it was an appropriate form of Tai Chi for older people with MCI because it involved only a few postures, hence it was easier for them to learn and remember. The Tai Chi classes were conducted in the open hall of the community center or a public playground with sufficient space, a flat floor and good lighting.To promote safety, measures include appropriate footwear, appropriate warm-up and cool-down, correct exercise technique and gradual increases in exercise dose will be emphasized in Tai Chi class. Incident report will be done to record and analyses causes for any adverse effect on Tai Chi training.To ensure adherence, the participants were required to sign attendance records. Telephone follow-up was arranged to provide emotional support and reinforce compliance if they were absent from two consecutive lessons. As well, the participants were advised to do daily practice at home to foster better mastery of the Tai Chi movements and build up a regular exercise habit. A guide book was issued to each participant, providing guidance to reinforce correct postures. For participants in the control group, they were considered as usual care group which could attend for different kinds of recreational activities provided by the community center. However, they were advised not to practice Tai Chi and not to join any structured physical training program during the study period to avoid possible aerobic capacity changes with exercise practices causing interferon on experimental outcomes.
- Data collection The outcome variables of the study comprised of general cognitive status, instrumental ADLs, and HRQOL of older participants. The outcome assessments were conducted at baseline, and at 4-month (at the end of study) for all participants.The Chinese version of the Mini-Mental State Examination (CMMSE) was used for global cognitive assessment. The Hong Kong Chinese version of Lawton's Instrumental Activities of Daily Living (IADL-CV) was used to assess the participants' IADLs levels and the Chinese version of the Short Form-12 Health Survey-Standard 1 (SF-12) was employed to assess the participants' perceived health status.
- Data analysis The IBM SPSS Version 24.0 (IBM Crop. Armonk, N.Y.) was used for data entry and analysis. All statistical tests involved were 2-tailed and the level of significance was set at 5%. Descriptive statistics, including mean, standard deviation, frequency, and percentage, were used to summarize and present the sample characteristics and outcome measures. Chi-square, Fisher's exact, and independent t- tests were used, as appropriate, to compare the characteristics of intervention and control group at the baseline. If there were significant differences between two groups of these characteristics, they were adjusted in the subsequent outcome analysis. Generalized Estimating Equations (GEE) was applied for comparing each of the repeated measures study outcomes (i.e. CMMSE score, IADL-CV score, physical and mental components of SF-12 as well as subscales of SF-12) between the two groups with adjustment for those demographic characteristics showing statistical incomparability between groups. Two dummy variables, Group and Time, were included in each GEE model to represent the baseline group difference (Intervention - Control) and the time effect on the control group (Post 16 weeks - Baseline), respectively. Furthermore, the interaction term, Group by Time (Group*Time) was also included to assess the differential change in each outcome between the two groups. GEE model could account for intra-correlated repeated measures outcome and produce unbiased effect estimated under the data missingness mechanism of missing completely at random (MCAR).
- Ethical consideration Approval for conducting the study was obtained from the Joint CUHK-NTEC Clinical Research Ethics Committee of the Chinese University of Hong Kong and the selected community elderly centers.The participants were required to sign a consent form. Information and the purpose of the study were explained. They could withdraw from the study at any time of their own will.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Tai Chi
- Keywords
- Tai Chi, Cognition, Instrumental activities of daily living, Health-related Quality of Life
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai ChiBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi group | Experimental | The Tai Chi group (i.e. the intervention group) received a 16-week Tai Chi program, of 32 sessions (2 sessions per week), each being one hour long. Receives: Behavioral: Tai Chi |
| Ususal care group | No intervention | The control group received the usual care offered by the respective centers. No intervention had been arranged for the control group during the study period. Participants in the control group were advised to attend different kinds of recreational activities provided by their community centers and to continue with their daily activities, including their usual general physical mobility and social activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline C-MMSE score at four months
The Chinese version of Mini-Mental State Examination (C-MMSE) is a global cognitive assessment tool.The first part of the CMMSE assesses respondent's abilities on orientation, memory and attention and the second part tests respondent's ability to name objects, understanding on verbal and written commands; higher score indicates for better cognitive performance.
Measured: he outcome assessment was conducted at baseline, and at 4 month (at the end of study)
Secondary outcomes (2)
Change from baseline IADL-CV score at four months
The Hong Kong Chinese version of Lawton Instrumental Activities of Daily Living (IADL-CV) is used to assess participants' performance level of instrumental activities of daily living. Nine domains of instrumental ADLs are assessed, including ability to use telephone, shopping, food preparation, house-keeping, laundry, use of transportation, financial management, handling medication and handyman work. Higher score for each domain represents better functional performance of the older people.
Measured: The outcome assessment was conducted at baseline, and at 4 month (at the end of study)
Change from baseline SF-12 score at four months
The Chinese version of the Short Form-12 Health Survey- Standard 1 (SF-12) is a brief version of the MOS 36-Item Short Form Health Survey (SF-36), incorporating 12 items rated on a Likert scale. It is employed to assess the perceived health status of the participants. It consists of 2 main components, the physical health and the mental health components.The physical health component (PCS) weighs the physical functioning, role-physical, bodily pain, and general health status of an individual. The mental health component (MCS) assesses on vitality, social functioning, role-emotional and general mental health status. Higher scores show better health conditions.
Measured: The outcome assessment was conducted at baseline, and at 4 month (at the end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start15 Dec 2015
- Primary completion1 Sep 2016
- Study completion1 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This interventional study involved two groups of participants, the experimental and usual-care control groups, with no randomization taking place. The participants were recruited from four community health centers and allocated to the experimental or control groups according to the centers to which they belonged.This arrangement avoided possible contamination of the experiment by diffusing the Tai Chi learning. The intervention group received a 16-week Tai Chi program, of 32 sessions (2 sessions per week), each being one hour long. The control group had no treatment regime and joined different recreational activity groups in the respective community centers as usual within the study period.
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minnie Siu, Chinese University of Hong Kong
- Investigators
- Siu Mei Yi, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404765
- Sponsor's protocol ID
- CREC.Ref,No:2015.348
- Status last verified
- Jan 2018
- First submitted
- 8 Jan 2018
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Siu MY, Lee DTF. Is Tai Chi an effective intervention for enhancing health-related quality of life in older people with mild cognitive impairment? An interventional study. Int J Older People Nurs. 2021 Sep;16(5):e12400. doi: 10.1111/opn.12400. Epub 2021 Jul 13.
PubMed 34254731Siu MY, Lee DTF. Effects of tai chi on cognition and instrumental activities of daily living in community dwelling older people with mild cognitive impairment. BMC Geriatr. 2018 Feb 2;18(1):37. doi: 10.1186/s12877-018-0720-8.
PubMed 29394884
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Tai Chi on Cognition and Instrumental Activities of Daily Living, and Health Related Quality of Life in Older People With Mild Cognitive Impairment .
- ClinicalTrials.gov ID
- NCT03404765
- Acronym / sponsor ID
- CREC.Ref,No:2015.348
- Conditions
- Mild Cognitive Impairment
- Keywords
- Tai Chi, Cognition, Instrumental activities of daily living, Health-related Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 Dec 2015 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 19 Jan 2018 (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.
The prevalence of older people with cognitive decline is increasing since the aging population is growing substantially worldwide. Cognitive impairment places older adults at high risk for functional disability. Previous researches have provided strong evidence on the beneficial effects of physical exercise on maintaining cognitive functions in older adults. Tai Chi is considered as a low to moderate intensity exercise, which is performed in a slow and rhythmic movement. It is a popular and safe exercise suitable for older people who have weaker muscle strength. The aim of this study was to determine the effects of Tai Chi on cognition and instrumental activities of daily living (I-ADLs), and health-related quality of life (HRQOL) in older Chinese adults with mild cognitive impairment (MCI).
The research hypothesis of the study stated: There is significant improvement in the general cognitive performance, functional capabilities of instrumental ADLs,the physical component and mental component of HRQOL between the group of community-dwelling older people with MCI who have participated and the control group who have not participated in the Tai Chi program.
Detailed description
- Study design \& sample recruitment: This was a quasi-experimental study which adopted the multi-site non-randomized control group pre- and post-test design. By adopting the multi-site design, better representation of the population could be obtained. This intervention study involved two groups of participant, the experimental and control groups, whereas no randomization would be taken place. The study was carried out in District Elderly Community Centers (DECCs) in Hong Kong. The DECC has been implemented since 2001 under the support from the Social Warfare Department (SWD) to provide community support services at district level to enable older people to remain in the community and to lead a healthy, respectful and dignified life.The service users are community-dwelling older citizens aged 60 or above living in the locality. Invitation letters were sent to various DECCs for joining the study. Finally, there were four elderly centers willing to participate in the study. The participants were recruited from the four DECCs using convenience sampling. To avoid the possible diffusion effect that might interfere the research result, all eligible participants in a community center were allocated to either experimental group or control group, who were treated with single intervention, so there would be no discussion among participants who have received different treatment regimes. The present study had employed a control group to enhance methodological rigor and included a pre-test to assess the equivalence between two groups, so the problem on selection biases could be alleviated.
- Sample size estimation A medium effect size of 0.5 was set for the study, based on previous research on the effect of Tai Chi on cognitive function. Based on the use of a sample size calculator (https://www2.ccrb.cuhk.edu.hk/stat/Other.htm), a sample of 64 per group was expected to provide 80% power to detect a medium effect size of 0.5, at a significance level of 0.05. Allowing for an attrition rate of 20% in the Tai Chi groups, 80 participants were recruited for each group.
- Intervention The intervention group received a 16-week Tai Chi program, of 32 sessions (two sessions per week) each one hour long.The capacity was around 20 people per class. A certified Tai Chi master taught the Yang-style simple form of Tai Chi to the participants allocated to the experimental group.There were four sets of movements included in the simplified form; this required less time for the older practitioners, who usually had less exercise endurance, to complete the whole set of movements. Moreover, it was an appropriate form of Tai Chi for older people with MCI because it involved only a few postures, hence it was easier for them to learn and remember. The Tai Chi classes were conducted in the open hall of the community center or a public playground with sufficient space, a flat floor and good lighting.To promote safety, measures include appropriate footwear, appropriate warm-up and cool-down, correct exercise technique and gradual increases in exercise dose will be emphasized in Tai Chi class. Incident report will be done to record and analyses causes for any adverse effect on Tai Chi training.To ensure adherence, the participants were required to sign attendance records. Telephone follow-up was arranged to provide emotional support and reinforce compliance if they were absent from two consecutive lessons. As well, the participants were advised to do daily practice at home to foster better mastery of the Tai Chi movements and build up a regular exercise habit. A guide book was issued to each participant, providing guidance to reinforce correct postures. For participants in the control group, they were considered as usual care group which could attend for different kinds of recreational activities provided by the community center. However, they were advised not to practice Tai Chi and not to join any structured physical training program during the study period to avoid possible aerobic capacity changes with exercise practices causing interferon on experimental outcomes.
- Data collection The outcome variables of the study comprised of general cognitive status, instrumental ADLs, and HRQOL of older participants. The outcome assessments were conducted at baseline, and at 4-month (at the end of study) for all participants.The Chinese version of the Mini-Mental State Examination (CMMSE) was used for global cognitive assessment. The Hong Kong Chinese version of Lawton's Instrumental Activities of Daily Living (IADL-CV) was used to assess the participants' IADLs levels and the Chinese version of the Short Form-12 Health Survey-Standard 1 (SF-12) was employed to assess the participants' perceived health status.
- Data analysis The IBM SPSS Version 24.0 (IBM Crop. Armonk, N.Y.) was used for data entry and analysis. All statistical tests involved were 2-tailed and the level of significance was set at 5%. Descriptive statistics, including mean, standard deviation, frequency, and percentage, were used to summarize and present the sample characteristics and outcome measures. Chi-square, Fisher's exact, and independent t- tests were used, as appropriate, to compare the characteristics of intervention and control group at the baseline. If there were significant differences between two groups of these characteristics, they were adjusted in the subsequent outcome analysis. Generalized Estimating Equations (GEE) was applied for comparing each of the repeated measures study outcomes (i.e. CMMSE score, IADL-CV score, physical and mental components of SF-12 as well as subscales of SF-12) between the two groups with adjustment for those demographic characteristics showing statistical incomparability between groups. Two dummy variables, Group and Time, were included in each GEE model to represent the baseline group difference (Intervention - Control) and the time effect on the control group (Post 16 weeks - Baseline), respectively. Furthermore, the interaction term, Group by Time (Group*Time) was also included to assess the differential change in each outcome between the two groups. GEE model could account for intra-correlated repeated measures outcome and produce unbiased effect estimated under the data missingness mechanism of missing completely at random (MCAR).
- Ethical consideration Approval for conducting the study was obtained from the Joint CUHK-NTEC Clinical Research Ethics Committee of the Chinese University of Hong Kong and the selected community elderly centers.The participants were required to sign a consent form. Information and the purpose of the study were explained. They could withdraw from the study at any time of their own will.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This interventional study involved two groups of participants, the experimental and usual-care control groups, with no randomization taking place. The participants were recruited from four community health centers and allocated to the experimental or control groups according to the centers to which they belonged.This arrangement avoided possible contamination of the experiment by diffusing the Tai Chi learning. The intervention group received a 16-week Tai Chi program, of 32 sessions (2 sessions per week), each being one hour long. The control group had no treatment regime and joined different recreational activity groups in the respective community centers as usual within the study period.
| Arm | Type | Receives |
|---|---|---|
| Tai Chi group | Experimental | Behavioral: Tai ChiThe Tai Chi group (i.e. the intervention group) received a 16-week Tai Chi program, of 32 sessions (2 sessions per week), each being one hour long. |
| Ususal care group | No intervention | –The control group received the usual care offered by the respective centers. No intervention had been arranged for the control group during the study period. Participants in the control group were advised to attend different kinds of recreational activities provided by their community centers and to continue with their daily activities, including their usual general physical mobility and social activities. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chinese people aged 60 years or above;
- Obtained the CMMSE screening score ranging from 19 to 28, which was corrected based on educational level (≥ 18 for illiterate respondents and ≥ 22 for those having received more than two years of education);
- Have ability to perform self-care functions on their own;
- No confirmed diagnosis of dementia, depression or other psychiatric illnesses;
- Not engaged in any structured physical exercise program or Tai Chi practice in the preceding year.
Key exclusion criteria (2 listed)
- Had a medical history of chronic alcoholism or brain trauma occurred in previous years; - Regular users of medications that could affect cognition;
- Contraindicated light to moderate physical exercise.
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 |
|---|---|---|
| Tai Chi | Behavioural | Tai Chi group |
Primary outcome
Change from baseline C-MMSE score at four months
Time frame: he outcome assessment was conducted at baseline, and at 4 month (at the end of study)
The Chinese version of Mini-Mental State Examination (C-MMSE) is a global cognitive assessment tool.The first part of the CMMSE assesses respondent's abilities on orientation, memory and attention and the second part tests respondent's ability to name objects, understanding on verbal and written commands; higher score indicates for better cognitive performance.
2 secondary outcomes
Change from baseline IADL-CV score at four months
Time frame: The outcome assessment was conducted at baseline, and at 4 month (at the end of study)
Change from baseline SF-12 score at four months
Time frame: The outcome assessment was conducted at baseline, and at 4 month (at the end of study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Derived from this study: PubMed 34254731Siu MY, Lee DTF. Is Tai Chi an effective intervention for enhancing health-related quality of life in older people with mild cognitive impairment? An interventional study. Int J Older People Nurs. 2021 Sep;16(5):e12400. doi: 10.1111/opn.12400. Epub 2021 Jul 13.
- Derived from this study: PubMed 29394884Siu MY, Lee DTF. Effects of tai chi on cognition and instrumental activities of daily living in community dwelling older people with mild cognitive impairment. BMC Geriatr. 2018 Feb 2;18(1):37. doi: 10.1186/s12877-018-0720-8.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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.
Siu Mei Yi principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi in people with Mild Cognitive Impairment, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline C-MMSE score at four months (time frame: he outcome assessment was conducted at baseline, and at 4 month (at the end of study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03404765, which also lists 2 linked publications.
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 19 Jan 2018.