Cognitive FrailtyNCT04467216
VR Motor-cognitive Training for Cognitive Frailty
A study testing Computerised cognitive training using virtual reality in people with Cognitive Frailty, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Cognitive frailty is a clinical syndrome in which cognitive impairment (e.g., poor memory, visuospatial function) and physical frailty (e.g., slowness, poor muscle strength, physical inactivity) co-exist. It is prevalent in community-dwelling older people. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognitive Frailty
- What is being tested?
- Computerised cognitive training using virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Jul 2020to 31 Dec 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 60 years,
- Community dwelling, as defined by living at home without staying in long-term care facilities (e.g., nursing home) in the last 12 months, and
- Cognitive frailty, as defined by co-existence of mild cognitive impairment and physical frailty,
- Mild cognitive impairment, measured by Montreal Cognitive Assessment (MoCA) ≤ 25 and Clinical Dementia Rating (CDR) = 0.5, and
- Frailty status from pre-frail to frail, measured by Fried Frailty Phenotype score ≥ 1.
Who cannot join
- Diagnosed dementia, according to subjects' medical record, or
- Probable dementia, as defined by MoCA ≤ 18, or
- Mobility restriction, as defined by Modified Functional Ambulatory Classification (MFAC) < Category 7 (i.e., Outdoor walker), or
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality Motor-cognitive Training for Older People With Cognitive Frailty: A Pilot Trial
Cognitive frailty is a clinical syndrome in which cognitive impairment (e.g., poor memory, visuospatial function) and physical frailty (e.g., slowness, poor muscle strength, physical inactivity) co-exist. It is prevalent in community-dwelling older people. The progressive decline of cognitive and physical functions restricts older people from participating in activities (e.g., social get-togethers). Reduced participation further jeopardizes their life-space mobility (e.g., ability to travel to areas far away from home). Therefore, those with cognitive frailty are at risk of developing dementia and becoming dependent.
Simultaneous motor-cognitive training is more effective at promoting optimal functioning in older people than motor or cognitive training alone. Gaming is effective at promoting the motivation to participate. The contents of games in the market are unrelated to the context or daily living of the elderly. Currently, available training is non-simultaneous. This makes the training less transferable to the daily life of the elderly and reduces its effects.
Virtual reality (VR) technology can provide a virtual space that mimics the real environment. This allows clients to participate in daily activities in a virtual space. Older people can be trained to improve their cognitive and physical skills in a painless, fun way. However, the effect and feasibility of employing simultaneous motor-cognitive training launching on a VR platform mimicking the daily living environment in older people with cognitive frailty is poorly known. This pilot trial aims to examine the preliminary effects on cognitive function and frailty syndrome, as well as examine the feasibility.
Read the detailed description
In the intervention, VR will be employed to simulate a daily living environment familiar to older people. Participants will wear a commercially available head-mounted VR system with hand-held controllers to experience the participation of daily activities in a virtual environment. Simultaneous physical and cognitive training will be embedded in the training system to promote optimal function. Participants will attend physical training in a sitting position through cycling on an ergometer and moving the hand-held controllers. Motion sensors built into the VR system and ergometer will track these movements to control everyday tasks in the virtual environment (e.g., moving around the city). Simultaneously, participants will undergo cognitive training by participating in various tasks demanding cognitive functions, such as visual-spatial (e.g., wayfinding) and problem-solving (e.g., wallet loss) functions. Gamification will be employed to promote the motivation to participate. All training activities will be gamified by blending in fun elements, such as difficulty-levelling, competition, and e-tokens. Co-participation is allowed to promote interpersonal interactions. The prototype enables real-time co-viewing among participants. Other elderly centre members and the activity facilitators can share the view of the participants in the game on either a large-screen monitor or a tablet computer. They can simultaneously talk about and share their gaming experiences.
- Conditions
- Cognitive Frailty
- Being tested
- Computerised cognitive training using virtual reality
- Keywords
- Cognitive frailty, Motor-cognitive training, Virtual reality, Gamification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerised cognitive training using virtual realityDevice
Immersive VR training system tailor-made for the daily living experiences in the Hong Kong context to provide interactive experiences for older people in Hong Kong.The VR systems available in the market for older people are only for non-interactive activities (e.g., watching movies) to provide unusual experiences for disabled older people who cannot travel too far from home.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | This arm will undertake VR simultaneous motor-cognitive training in 30 minutes session, twice a week for 8 weeks Receives: Device: Computerised cognitive training using virtual reality |
| Control Group | No intervention | This arm will be doing existing forms of motor-cognitive training in 30 minutes session, twice a week for 8 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global cognitive function
Montreal Cognitive Assessment (score), scores on the MoCA range from zero to 30.
With a score of 26 and higher generally considered normal, with 25 to 18 are considered Mild Cognitive Impairment and with score lower then 18 are defined as Alzheimer's disease.
Measured: Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Selective attention
Stroop test (score)
Measured: Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Visual-spatial perception
Visual Object Space Perception test (score)
Measured: Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Secondary outcomes (3)
Frailty
Fried Frailty Phenotype (score)
Measured: Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Walking
Timed up and go test (seconds)
Measured: Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Strength
Grip strength by dynamometer (kg)
Measured: Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start15 Jul 2020
- Primary completion30 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Cognitive FrailtyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A total of 16 subjects with cognitive frailty will be assigned into 2 groups. Eight participants will be assigned to the intervention group in which they will undertake VR simultaneous motor-cognitive training and eight participants will be assigned to the control group in which existing forms of non-VR sequential motor-cognitive training will be provided. Both intervention and control groups will employ the same intervention dosage including course, session duration and frequency. The following dosage is employed because they are also the same dosage used in the VR simultaneous motor-cognitive training that we proposed. I.e., * Course: eight weeks * Session duration: 30 minutes * Frequency: twice per week
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Rick Kwan, The Hong Kong Polytechnic University
- Investigators
- Rick Kwan, Study chair, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467216
- Sponsor's protocol ID
- ZB1H
- Status last verified
- Aug 2021
- First submitted
- 11 Jun 2020
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ruan Q, Yu Z, Chen M, Bao Z, Li J, He W. Cognitive frailty, a novel target for the prevention of elderly dependency. Ageing Res Rev. 2015 Mar;20:1-10. doi: 10.1016/j.arr.2014.12.004. Epub 2014 Dec 30.
PubMed 25555677Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
PubMed 15817019Yeung PY, Wong LL, Chan CC, Leung JL, Yung CY. A validation study of the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) in Chinese older adults in Hong Kong. Hong Kong Med J. 2014 Dec;20(6):504-10. doi: 10.12809/hkmj144219. Epub 2014 Aug 15.
PubMed 25125421Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
PubMed 11253156Rosanna Chau MW, Chan SP, Wong YW, Lau MYP. Reliability and validity of the Modified Functional Ambulation Classification in patients with hip fracture. Hong Kong Physiotherapy Journal. 2013;31(1):41-44.
Kelaiditi E, Cesari M, Canevelli M, van Kan GA, Ousset PJ, Gillette-Guyonnet S, Ritz P, Duveau F, Soto ME, Provencher V, Nourhashemi F, Salva A, Robert P, Andrieu S, Rolland Y, Touchon J, Fitten JL, Vellas B; IANA/IAGG. Cognitive frailty: rational and definition from an (I.A.N.A./I.A.G.G.) international consensus group. J Nutr Health Aging. 2013 Sep;17(9):726-34. doi: 10.1007/s12603-013-0367-2.
PubMed 24154642Desjardins-Crepeau L, Berryman N, Fraser SA, Vu TT, Kergoat MJ, Li KZ, Bosquet L, Bherer L. Effects of combined physical and cognitive training on fitness and neuropsychological outcomes in healthy older adults. Clin Interv Aging. 2016 Sep 19;11:1287-1299. doi: 10.2147/cia.s115711. eCollection 2016.
PubMed 27698558Lauenroth A, Ioannidis AE, Teichmann B. Influence of combined physical and cognitive training on cognition: a systematic review. BMC Geriatr. 2016 Jul 18;16:141. doi: 10.1186/s12877-016-0315-1.
PubMed 27431673Tait JL, Duckham RL, Milte CM, Main LC, Daly RM. Influence of Sequential vs. Simultaneous Dual-Task Exercise Training on Cognitive Function in Older Adults. Front Aging Neurosci. 2017 Nov 7;9:368. doi: 10.3389/fnagi.2017.00368. eCollection 2017.
PubMed 29163146de Vries AW, Faber G, Jonkers I, Van Dieen JH, Verschueren SMP. Virtual reality balance training for elderly: Similar skiing games elicit different challenges in balance training. Gait Posture. 2018 Jan;59:111-116. doi: 10.1016/j.gaitpost.2017.10.006. Epub 2017 Oct 5.
PubMed 29028622Kwan RYC, Liu JYW, Fong KNK, Qin J, Leung PK, Sin OSK, Hon PY, Suen LW, Tse MK, Lai CK. Feasibility and Effects of Virtual Reality Motor-Cognitive Training in Community-Dwelling Older People With Cognitive Frailty: Pilot Randomized Controlled Trial. JMIR Serious Games. 2021 Aug 6;9(3):e28400. doi: 10.2196/28400.
PubMed 34383662
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Motor-cognitive Training for Older People With Cognitive Frailty: A Pilot Trial
- ClinicalTrials.gov ID
- NCT04467216
- Acronym / sponsor ID
- ZB1H
- Conditions
- Cognitive Frailty
- Keywords
- Cognitive frailty, Motor-cognitive training, Virtual reality, Gamification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 10 Jul 2020 (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.
Cognitive frailty is a clinical syndrome in which cognitive impairment (e.g., poor memory, visuospatial function) and physical frailty (e.g., slowness, poor muscle strength, physical inactivity) co-exist. It is prevalent in community-dwelling older people. The progressive decline of cognitive and physical functions restricts older people from participating in activities (e.g., social get-togethers). Reduced participation further jeopardizes their life-space mobility (e.g., ability to travel to areas far away from home). Therefore, those with cognitive frailty are at risk of developing dementia and becoming dependent.
Simultaneous motor-cognitive training is more effective at promoting optimal functioning in older people than motor or cognitive training alone. Gaming is effective at promoting the motivation to participate. The contents of games in the market are unrelated to the context or daily living of the elderly. Currently, available training is non-simultaneous. This makes the training less transferable to the daily life of the elderly and reduces its effects.
Virtual reality (VR) technology can provide a virtual space that mimics the real environment. This allows clients to participate in daily activities in a virtual space. Older people can be trained to improve their cognitive and physical skills in a painless, fun way. However, the effect and feasibility of employing simultaneous motor-cognitive training launching on a VR platform mimicking the daily living environment in older people with cognitive frailty is poorly known. This pilot trial aims to examine the preliminary effects on cognitive function and frailty syndrome, as well as examine the feasibility.
Detailed description
In the intervention, VR will be employed to simulate a daily living environment familiar to older people. Participants will wear a commercially available head-mounted VR system with hand-held controllers to experience the participation of daily activities in a virtual environment. Simultaneous physical and cognitive training will be embedded in the training system to promote optimal function. Participants will attend physical training in a sitting position through cycling on an ergometer and moving the hand-held controllers. Motion sensors built into the VR system and ergometer will track these movements to control everyday tasks in the virtual environment (e.g., moving around the city). Simultaneously, participants will undergo cognitive training by participating in various tasks demanding cognitive functions, such as visual-spatial (e.g., wayfinding) and problem-solving (e.g., wallet loss) functions. Gamification will be employed to promote the motivation to participate. All training activities will be gamified by blending in fun elements, such as difficulty-levelling, competition, and e-tokens. Co-participation is allowed to promote interpersonal interactions. The prototype enables real-time co-viewing among participants. Other elderly centre members and the activity facilitators can share the view of the participants in the game on either a large-screen monitor or a tablet computer. They can simultaneously talk about and share their gaming experiences.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A total of 16 subjects with cognitive frailty will be assigned into 2 groups. Eight participants will be assigned to the intervention group in which they will undertake VR simultaneous motor-cognitive training and eight participants will be assigned to the control group in which existing forms of non-VR sequential motor-cognitive training will be provided. Both intervention and control groups will employ the same intervention dosage including course, session duration and frequency. The following dosage is employed because they are also the same dosage used in the VR simultaneous motor-cognitive training that we proposed. I.e., * Course: eight weeks * Session duration: 30 minutes * Frequency: twice per week
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Computerised cognitive training using virtual realityThis arm will undertake VR simultaneous motor-cognitive training in 30 minutes session, twice a week for 8 weeks |
| Control Group | No intervention | –This arm will be doing existing forms of motor-cognitive training in 30 minutes session, twice a week for 8 weeks |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 60 years,
- Community dwelling, as defined by living at home without staying in long-term care facilities (e.g., nursing home) in the last 12 months, and
- Cognitive frailty, as defined by co-existence of mild cognitive impairment and physical frailty,
Key exclusion criteria (3 listed)
- Diagnosed dementia, according to subjects' medical record, or
- Probable dementia, as defined by MoCA ≤ 18, or
- Mobility restriction, as defined by Modified Functional Ambulatory Classification (MFAC) < Category 7 (i.e., Outdoor walker), or
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 |
|---|---|---|
| Computerised cognitive training using virtual realityImmersive VR training system tailor-made for the daily living experiences in the Hong Kong context to provide interactive experiences for older people in Hong Kong.The VR systems available in the market for older people are only for non-interactive activities (e.g., watching movies) to provide unusual experiences for disabled older people who cannot travel too far from home. | Device | Intervention group |
Primary outcome
Global cognitive function
Time frame: Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Montreal Cognitive Assessment (score), scores on the MoCA range from zero to 30. With a score of 26 and higher generally considered normal, with 25 to 18 are considered Mild Cognitive Impairment and with score lower then 18 are defined as Alzheimer's disease.
Selective attention
Time frame: Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Stroop test (score)
Visual-spatial perception
Time frame: Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Visual Object Space Perception test (score)
3 secondary outcomes
Frailty
Time frame: Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Walking
Time frame: Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Strength
Time frame: Change is being assessed: "baseline" and "immediately after the completion" (2 months)
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 27 Aug 2021.
- Background: PubMed 25555677Ruan Q, Yu Z, Chen M, Bao Z, Li J, He W. Cognitive frailty, a novel target for the prevention of elderly dependency. Ageing Res Rev. 2015 Mar;20:1-10. doi: 10.1016/j.arr.2014.12.004. Epub 2014 Dec 30.
- Background: PubMed 15817019Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
- Background: PubMed 25125421Yeung PY, Wong LL, Chan CC, Leung JL, Yung CY. A validation study of the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) in Chinese older adults in Hong Kong. Hong Kong Med J. 2014 Dec;20(6):504-10. doi: 10.12809/hkmj144219. Epub 2014 Aug 15.
- Background: PubMed 11253156Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
- BackgroundRosanna Chau MW, Chan SP, Wong YW, Lau MYP. Reliability and validity of the Modified Functional Ambulation Classification in patients with hip fracture. Hong Kong Physiotherapy Journal. 2013;31(1):41-44.
- Background: PubMed 24154642Kelaiditi E, Cesari M, Canevelli M, van Kan GA, Ousset PJ, Gillette-Guyonnet S, Ritz P, Duveau F, Soto ME, Provencher V, Nourhashemi F, Salva A, Robert P, Andrieu S, Rolland Y, Touchon J, Fitten JL, Vellas B; IANA/IAGG. Cognitive frailty: rational and definition from an (I.A.N.A./I.A.G.G.) international consensus group. J Nutr Health Aging. 2013 Sep;17(9):726-34. doi: 10.1007/s12603-013-0367-2.
- Background: PubMed 27698558Desjardins-Crepeau L, Berryman N, Fraser SA, Vu TT, Kergoat MJ, Li KZ, Bosquet L, Bherer L. Effects of combined physical and cognitive training on fitness and neuropsychological outcomes in healthy older adults. Clin Interv Aging. 2016 Sep 19;11:1287-1299. doi: 10.2147/cia.s115711. eCollection 2016.
- Background: PubMed 27431673Lauenroth A, Ioannidis AE, Teichmann B. Influence of combined physical and cognitive training on cognition: a systematic review. BMC Geriatr. 2016 Jul 18;16:141. doi: 10.1186/s12877-016-0315-1.
- Background: PubMed 29163146Tait JL, Duckham RL, Milte CM, Main LC, Daly RM. Influence of Sequential vs. Simultaneous Dual-Task Exercise Training on Cognitive Function in Older Adults. Front Aging Neurosci. 2017 Nov 7;9:368. doi: 10.3389/fnagi.2017.00368. eCollection 2017.
- Background: PubMed 29028622de Vries AW, Faber G, Jonkers I, Van Dieen JH, Verschueren SMP. Virtual reality balance training for elderly: Similar skiing games elicit different challenges in balance training. Gait Posture. 2018 Jan;59:111-116. doi: 10.1016/j.gaitpost.2017.10.006. Epub 2017 Oct 5.
- Derived from this study: PubMed 34383662Kwan RYC, Liu JYW, Fong KNK, Qin J, Leung PK, Sin OSK, Hon PY, Suen LW, Tse MK, Lai CK. Feasibility and Effects of Virtual Reality Motor-Cognitive Training in Community-Dwelling Older People With Cognitive Frailty: Pilot Randomized Controlled Trial. JMIR Serious Games. 2021 Aug 6;9(3):e28400. doi: 10.2196/28400.
- Individual participant dataSharing planned: No
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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.
Rick Kwan study chair
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerised cognitive training using virtual reality in people with Cognitive Frailty, run by The Hong Kong Polytechnic University 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 3 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 27 Aug 2021. 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?
Global cognitive function (time frame: Change is being assessed: "baseline" and "immediately after the completion" (2 months)). The study lists 3 primary outcomes in all. 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 NCT04467216, which also lists 11 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 27 Aug 2021.