Dementia AlzheimersNCT03593941
Ageing Gut Brain Interactions
An observational study of Dementia Alzheimers, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
This research project will address a desperate need for evidence on how diet could be used to treat and improve symptoms of Alzheimer's disease (AD). It has been estimated that 36 million people have dementia worldwide, and in older people Alzheimer's disease accounts for 60-70% of all dementia. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia Alzheimers
- What is being tested?
- Standard Diet
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Aug 2018to 31 Jan 2020
- Phase
- Observational
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Care home residents
Who may be able to join
- Resident in a care home
Who cannot join
- Use of antibiotics in last 8 weeks
- Active gastrointestinal disease
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Aberdeen
Aberdeen, Grampian, AB25 2ZD
About this study
This research project will address a desperate need for evidence on how diet could be used to treat and improve symptoms of Alzheimer's disease (AD). It has been estimated that 36 million people have dementia worldwide, and in older people Alzheimer's disease accounts for 60-70% of all dementia. Research supports the hypothesis that modifiable lifestyle-related factors are associated with cognitive decline, which opens new avenues for prevention or modification of disease.
The concept that inspires this proposal 'Ageing-Gut-Brain Interactions study' is that the gut microbiota impact upon the gut-brain axis and thereby on behaviour, including challenging behaviours often associated with dementia. In the absence of available cures for Alzheimer's disease, diet is an important modifiable component but knowledge about the role of diet in clinical symptoms of dementia is currently very limited. A recent study from Ireland from the European Union funded Nu-Age cohort reported that the gut microbiota profile in the elderly was different between community-living and institutionalized individuals, with specific microbiome profiles correlating with frailty and poor health.
Read more
Changes in dietary composition and diversity were considered the main drivers of the shifts in gut bacteria profile. In this multi-disciplinary research study, the investigators will assess the gut microbiota composition in people with Alzheimer's dementia with and without challenging behaviours; test the feasibility of recruitment; and provide initial data to support a future grant application involving a dietary intervention study in patients with Alzheimer's disease.
The investigators will test the hypothesis that the gut-brain axis promotes behavioural changes in Alzheimer's dementia and is responsive to changes in gut microbiota profile, by comparing the gut microbiota profile between three participant groups (1) Alzheimer's dementia with challenging behaviour, (2) Alzheimer's dementia without challenging behaviour, and (3) a control group of healthy age-matched elderly. The investigators will also carry out a survey of care homes to assess willingness to participate in a future dietary supplementation study.
Read the detailed description
Introduction
Healthy life expectancy is a key area of research. It has been estimated that 36 million people have dementia worldwide and that there are 4.6 million new cases of dementia every year. Epidemiological evidence supports the hypothesis that modifiable lifestyle-related factors are associated with cognitive decline, opening new avenues for prevention. Alzheimer's disease is the commonest cause of dementia in older people, accounting for 60-70% of all dementia cases when using traditional diagnostic criteria for dementia subtypes.
There are no available cures for AD, but an alternative approach is to use strategies that delay disease progression at an early stage. Optimal brain function results from highly complex interactions between numerous genetic and environmental factors, including food intake, physical activity, age and stress. Diet in particular has become the object of intense research in relation to cognitive aging and neurodegenerative diseases.
The gut microbiota is a large, diverse collection of microbes, collectively containing 100 times more genes than the host. It is host-specific, contains heritable components, can be modified by diet, surgery or antibiotics, and in its absence nearly all aspects of host physiology are affected. It is now realised that the human microbiota is a previously overlooked system that makes a significant contribution to human biology and development.There is a new and exciting field of research with limited published data in the elderly, that could provide a basis for the design of novel, microbiota-targeted, therapies to improve care of older people suffering from Alzheimer's dementia.
There is increasing evidence that identifies the gut microbiota as a key conduit between nutrition and brain function. Reduction in the frequency of genes encoding short chain fatty acid (SCFA) production was prominent among institutionalized older adults, as were increases in circulating pro-inflammatory cytokines tumour necrosis factor-alpha, interleukins-6 and -8, and C-reactive protein.
Rationale for Study
Hypothesis: The composition and/or diversity of the gut microbiota is different between healthy elderly and those with Alzheimer's dementia, who do or do not exhibit behaviour(s) that are challenging.
The concept that inspires Ageing-GB is that our gut microbiota impact upon the gut-brain axis and thereby on behaviour. There is a need to understand the nature of that impact, the underlying mechanisms, and how changes in diet can reprogram our gut microbiota-brain axis to resolve or reduce clinical symptoms associated with Alzheimer's dementia.
However, to the investigator's knowledge, there has been no published work to examine the gut microbiota profile in patients with Alzheimer's disease. Consequently, the investigators first need to demonstrate the differences in microbiota profile between AD patients with or without behaviours that are more challenging to manage. This work is anticipated to provide fundamental evidence to support dietary modification or supplementation as cost-effective and safe avenues for alleviating signs and symptoms of dementia in this vulnerable group and thus reduce the carer burden.
This study will require the co-operation of care home managers and staff, and investigators will thus simultaneously assess the feasibility of performing a nutritional intervention study in this group of individuals, in this setting.
- Conditions
- Dementia Alzheimers
- Being tested
- Standard Diet
- Keywords
- Ageing, Gut Microbiota, Challenging behaviour, Dementia
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard DietOther
Participants will consume the standard diet provided in care home
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's dementia and challenging behaviour symptoms | Care home residents >65y No interventions as this is a pilot project Receives: Other: Standard Diet | |
| Alzheimer's dementia and no challenging behavioural symptoms | Care home residents >65y No interventions as this is a pilot project Receives: Other: Standard Diet | |
| Older adults without dementia | Care home residents >65y No interventions as this is a pilot project Receives: Other: Standard Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Faecal sample Short chain fatty acid (SCFA) profile
Indicator of gut microbiota metabolic activity
Measured: 4 months
Faecal sample Microbiota DNA profile
Indicator of gut microbiota composition
Measured: 4 months
Secondary outcomes (2)
Macronutrient composition of care home menu
The weekly care home menu will be analysed for the macronutrient contents (carbohydrate, fat and protein)
Measured: 4 months
Frequency of challenging behaviours
Log of the number of incidents of participant displaying challenging behaviours requiring care home staff intervention
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start2 Aug 2018
- Primary completion6 Aug 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Dementia AlzheimersStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Grampian, Tenovus Scotland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593941
- Sponsor's protocol ID
- 2/103/17
- Status last verified
- Mar 2021
- First submitted
- 21 Jun 2018
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share data with other researchers
Publications
Blennow K, de Leon MJ, Zetterberg H. Alzheimer's disease. Lancet. 2006 Jul 29;368(9533):387-403. doi: 10.1016/S0140-6736(06)69113-7.
PubMed 16876668Claesson MJ, Jeffery IB, Conde S, Power SE, O'Connor EM, Cusack S, Harris HM, Coakley M, Lakshminarayanan B, O'Sullivan O, Fitzgerald GF, Deane J, O'Connor M, Harnedy N, O'Connor K, O'Mahony D, van Sinderen D, Wallace M, Brennan L, Stanton C, Marchesi JR, Fitzgerald AP, Shanahan F, Hill C, Ross RP, O'Toole PW. Gut microbiota composition correlates with diet and health in the elderly. Nature. 2012 Aug 9;488(7410):178-84. doi: 10.1038/nature11319.
PubMed 22797518Ferri CP, Prince M, Brayne C, Brodaty H, Fratiglioni L, Ganguli M, Hall K, Hasegawa K, Hendrie H, Huang Y, Jorm A, Mathers C, Menezes PR, Rimmer E, Scazufca M; Alzheimer's Disease International. Global prevalence of dementia: a Delphi consensus study. Lancet. 2005 Dec 17;366(9503):2112-7. doi: 10.1016/S0140-6736(05)67889-0.
PubMed 16360788Fratiglioni L, De Ronchi D, Aguero-Torres H. Worldwide prevalence and incidence of dementia. Drugs Aging. 1999 Nov;15(5):365-75. doi: 10.2165/00002512-199915050-00004.
PubMed 10600044Goyal MS, Venkatesh S, Milbrandt J, Gordon JI, Raichle ME. Feeding the brain and nurturing the mind: Linking nutrition and the gut microbiota to brain development. Proc Natl Acad Sci U S A. 2015 Nov 17;112(46):14105-12. doi: 10.1073/pnas.1511465112.
PubMed 26578751Lobo A, Launer LJ, Fratiglioni L, Andersen K, Di Carlo A, Breteler MM, Copeland JR, Dartigues JF, Jagger C, Martinez-Lage J, Soininen H, Hofman A. Prevalence of dementia and major subtypes in Europe: A collaborative study of population-based cohorts. Neurologic Diseases in the Elderly Research Group. Neurology. 2000;54(11 Suppl 5):S4-9.
PubMed 10854354Mariat D, Firmesse O, Levenez F, Guimaraes V, Sokol H, Dore J, Corthier G, Furet JP. The Firmicutes/Bacteroidetes ratio of the human microbiota changes with age. BMC Microbiol. 2009 Jun 9;9:123. doi: 10.1186/1471-2180-9-123.
PubMed 19508720Marchesi JR, Adams DH, Fava F, Hermes GD, Hirschfield GM, Hold G, Quraishi MN, Kinross J, Smidt H, Tuohy KM, Thomas LV, Zoetendal EG, Hart A. The gut microbiota and host health: a new clinical frontier. Gut. 2016 Feb;65(2):330-9. doi: 10.1136/gutjnl-2015-309990. Epub 2015 Sep 2.
PubMed 26338727Prince M, Bryce R, Albanese E, Wimo A, Ribeiro W, Ferri CP. The global prevalence of dementia: a systematic review and metaanalysis. Alzheimers Dement. 2013 Jan;9(1):63-75.e2. doi: 10.1016/j.jalz.2012.11.007.
PubMed 23305823Solfrizzi V, Capurso C, D'Introno A, Colacicco AM, Santamato A, Ranieri M, Fiore P, Capurso A, Panza F. Lifestyle-related factors in predementia and dementia syndromes. Expert Rev Neurother. 2008 Jan;8(1):133-58. doi: 10.1586/14737175.8.1.133.
PubMed 18088206
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ageing Gut Brain Interactions
- ClinicalTrials.gov ID
- NCT03593941
- Acronym / sponsor ID
- 2/103/17
- Conditions
- Dementia Alzheimers
- Keywords
- Ageing, Gut Microbiota, Challenging behaviour, Dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- NHS Grampian, Tenovus Scotland
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- 6 Aug 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 20 Jul 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.
This research project will address a desperate need for evidence on how diet could be used to treat and improve symptoms of Alzheimer's disease (AD). It has been estimated that 36 million people have dementia worldwide, and in older people Alzheimer's disease accounts for 60-70% of all dementia. Research supports the hypothesis that modifiable lifestyle-related factors are associated with cognitive decline, which opens new avenues for prevention or modification of disease.
The concept that inspires this proposal 'Ageing-Gut-Brain Interactions study' is that the gut microbiota impact upon the gut-brain axis and thereby on behaviour, including challenging behaviours often associated with dementia. In the absence of available cures for Alzheimer's disease, diet is an important modifiable component but knowledge about the role of diet in clinical symptoms of dementia is currently very limited. A recent study from Ireland from the European Union funded Nu-Age cohort reported that the gut microbiota profile in the elderly was different between community-living and institutionalized individuals, with specific microbiome profiles correlating with frailty and poor health.
Changes in dietary composition and diversity were considered the main drivers of the shifts in gut bacteria profile. In this multi-disciplinary research study, the investigators will assess the gut microbiota composition in people with Alzheimer's dementia with and without challenging behaviours; test the feasibility of recruitment; and provide initial data to support a future grant application involving a dietary intervention study in patients with Alzheimer's disease.
The investigators will test the hypothesis that the gut-brain axis promotes behavioural changes in Alzheimer's dementia and is responsive to changes in gut microbiota profile, by comparing the gut microbiota profile between three participant groups (1) Alzheimer's dementia with challenging behaviour, (2) Alzheimer's dementia without challenging behaviour, and (3) a control group of healthy age-matched elderly. The investigators will also carry out a survey of care homes to assess willingness to participate in a future dietary supplementation study.
Detailed description
Introduction
Healthy life expectancy is a key area of research. It has been estimated that 36 million people have dementia worldwide and that there are 4.6 million new cases of dementia every year. Epidemiological evidence supports the hypothesis that modifiable lifestyle-related factors are associated with cognitive decline, opening new avenues for prevention. Alzheimer's disease is the commonest cause of dementia in older people, accounting for 60-70% of all dementia cases when using traditional diagnostic criteria for dementia subtypes.
There are no available cures for AD, but an alternative approach is to use strategies that delay disease progression at an early stage. Optimal brain function results from highly complex interactions between numerous genetic and environmental factors, including food intake, physical activity, age and stress. Diet in particular has become the object of intense research in relation to cognitive aging and neurodegenerative diseases.
The gut microbiota is a large, diverse collection of microbes, collectively containing 100 times more genes than the host. It is host-specific, contains heritable components, can be modified by diet, surgery or antibiotics, and in its absence nearly all aspects of host physiology are affected. It is now realised that the human microbiota is a previously overlooked system that makes a significant contribution to human biology and development.There is a new and exciting field of research with limited published data in the elderly, that could provide a basis for the design of novel, microbiota-targeted, therapies to improve care of older people suffering from Alzheimer's dementia.
There is increasing evidence that identifies the gut microbiota as a key conduit between nutrition and brain function. Reduction in the frequency of genes encoding short chain fatty acid (SCFA) production was prominent among institutionalized older adults, as were increases in circulating pro-inflammatory cytokines tumour necrosis factor-alpha, interleukins-6 and -8, and C-reactive protein.
Rationale for Study
Hypothesis: The composition and/or diversity of the gut microbiota is different between healthy elderly and those with Alzheimer's dementia, who do or do not exhibit behaviour(s) that are challenging.
The concept that inspires Ageing-GB is that our gut microbiota impact upon the gut-brain axis and thereby on behaviour. There is a need to understand the nature of that impact, the underlying mechanisms, and how changes in diet can reprogram our gut microbiota-brain axis to resolve or reduce clinical symptoms associated with Alzheimer's dementia.
However, to the investigator's knowledge, there has been no published work to examine the gut microbiota profile in patients with Alzheimer's disease. Consequently, the investigators first need to demonstrate the differences in microbiota profile between AD patients with or without behaviours that are more challenging to manage. This work is anticipated to provide fundamental evidence to support dietary modification or supplementation as cost-effective and safe avenues for alleviating signs and symptoms of dementia in this vulnerable group and thus reduce the carer burden.
This study will require the co-operation of care home managers and staff, and investigators will thus simultaneously assess the feasibility of performing a nutritional intervention study in this group of individuals, in this setting.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's dementia and challenging behaviour symptoms | – | Other: Standard DietCare home residents >65y No interventions as this is a pilot project |
| Alzheimer's dementia and no challenging behavioural symptoms | – | Other: Standard DietCare home residents >65y No interventions as this is a pilot project |
| Older adults without dementia | – | Other: Standard DietCare home residents >65y No interventions as this is a pilot project |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Care home residents
Key inclusion criteria (1 listed)
- Resident in a care home
Key exclusion criteria (3 listed)
- Use of antibiotics in last 8 weeks
- Active gastrointestinal disease
- Unable to provide informed consent
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 |
|---|---|---|
| Standard DietParticipants will consume the standard diet provided in care home | Other | Alzheimer's dementia and challenging behaviour symptoms, Alzheimer's dementia and no challenging behavioural symptoms, Older adults without dementia |
Primary outcome
Faecal sample Short chain fatty acid (SCFA) profile
Time frame: 4 months
Indicator of gut microbiota metabolic activity
Faecal sample Microbiota DNA profile
Time frame: 4 months
Indicator of gut microbiota composition
2 secondary outcomes
Macronutrient composition of care home menu
Time frame: 4 months
Frequency of challenging behaviours
Time frame: 4 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 9 Mar 2021.
- Background: PubMed 16876668Blennow K, de Leon MJ, Zetterberg H. Alzheimer's disease. Lancet. 2006 Jul 29;368(9533):387-403. doi: 10.1016/S0140-6736(06)69113-7.
- Background: PubMed 22797518Claesson MJ, Jeffery IB, Conde S, Power SE, O'Connor EM, Cusack S, Harris HM, Coakley M, Lakshminarayanan B, O'Sullivan O, Fitzgerald GF, Deane J, O'Connor M, Harnedy N, O'Connor K, O'Mahony D, van Sinderen D, Wallace M, Brennan L, Stanton C, Marchesi JR, Fitzgerald AP, Shanahan F, Hill C, Ross RP, O'Toole PW. Gut microbiota composition correlates with diet and health in the elderly. Nature. 2012 Aug 9;488(7410):178-84. doi: 10.1038/nature11319.
- Background: PubMed 16360788Ferri CP, Prince M, Brayne C, Brodaty H, Fratiglioni L, Ganguli M, Hall K, Hasegawa K, Hendrie H, Huang Y, Jorm A, Mathers C, Menezes PR, Rimmer E, Scazufca M; Alzheimer's Disease International. Global prevalence of dementia: a Delphi consensus study. Lancet. 2005 Dec 17;366(9503):2112-7. doi: 10.1016/S0140-6736(05)67889-0.
- Background: PubMed 10600044Fratiglioni L, De Ronchi D, Aguero-Torres H. Worldwide prevalence and incidence of dementia. Drugs Aging. 1999 Nov;15(5):365-75. doi: 10.2165/00002512-199915050-00004.
- Background: PubMed 26578751Goyal MS, Venkatesh S, Milbrandt J, Gordon JI, Raichle ME. Feeding the brain and nurturing the mind: Linking nutrition and the gut microbiota to brain development. Proc Natl Acad Sci U S A. 2015 Nov 17;112(46):14105-12. doi: 10.1073/pnas.1511465112.
- Background: PubMed 10854354Lobo A, Launer LJ, Fratiglioni L, Andersen K, Di Carlo A, Breteler MM, Copeland JR, Dartigues JF, Jagger C, Martinez-Lage J, Soininen H, Hofman A. Prevalence of dementia and major subtypes in Europe: A collaborative study of population-based cohorts. Neurologic Diseases in the Elderly Research Group. Neurology. 2000;54(11 Suppl 5):S4-9.
- Background: PubMed 19508720Mariat D, Firmesse O, Levenez F, Guimaraes V, Sokol H, Dore J, Corthier G, Furet JP. The Firmicutes/Bacteroidetes ratio of the human microbiota changes with age. BMC Microbiol. 2009 Jun 9;9:123. doi: 10.1186/1471-2180-9-123.
- Background: PubMed 26338727Marchesi JR, Adams DH, Fava F, Hermes GD, Hirschfield GM, Hold G, Quraishi MN, Kinross J, Smidt H, Tuohy KM, Thomas LV, Zoetendal EG, Hart A. The gut microbiota and host health: a new clinical frontier. Gut. 2016 Feb;65(2):330-9. doi: 10.1136/gutjnl-2015-309990. Epub 2015 Sep 2.
- Background: PubMed 23305823Prince M, Bryce R, Albanese E, Wimo A, Ribeiro W, Ferri CP. The global prevalence of dementia: a systematic review and metaanalysis. Alzheimers Dement. 2013 Jan;9(1):63-75.e2. doi: 10.1016/j.jalz.2012.11.007.
- Background: PubMed 18088206Solfrizzi V, Capurso C, D'Introno A, Colacicco AM, Santamato A, Ranieri M, Fiore P, Capurso A, Panza F. Lifestyle-related factors in predementia and dementia syndromes. Expert Rev Neurother. 2008 Jan;8(1):133-58. doi: 10.1586/14737175.8.1.133.
- Individual participant dataSharing planned: No. No plans to share data with other researchers
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia Alzheimers, run by University of Aberdeen at 1 site in United Kingdom.
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 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 9 Mar 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 United Kingdom. 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?
Faecal sample Short chain fatty acid (SCFA) profile (time frame: 4 months). The study lists 2 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 NCT03593941, which also lists 10 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 9 Mar 2021.