BPSD (Behavioral and Psycological Symptoms of Dementia)NCT03662360
Elderly Demented Patients: Aromatherapy Complementary to Psychopharmacotherapy Psychological Disorders and BPSD Behavior
A study testing essential oils in people with BPSD (Behavioral and Psycological Symptoms of Dementia), run by Clinica Luganese Moncucco at 1 site in Switzerland.
Trial summary
Behavioral and psycological symptoms of dementia, (BPSD) are one of the major problem for families, doctors and for patients the same. To reduce the side effects of the standard treatments, is important to find an alternative methods of treatment, eg the aromatherapy. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- BPSD (Behavioral and Psycological Symptoms of Dementia)
- What is being tested?
- essential oils
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 May 2018to 30 Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patients admitted to the acute geriatric ward;
- patients with a known diagnosis of dementia associated with BPSD or diagnosis performed during hospitalization.
Who cannot join
- patients with alcohol-based dementia;
- patients with Mild Cognitive Impairment (MCI) - section 4 -;
- patients with language barrier;
- patients already being treated with aromatherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Elderly Patients With Dementia in the Department of Acute Geriatrics: Pilot Study, Monocentric, Randomized Use of Aromatherapy as a Complementary Treatment to Psychopharmacotherapy in Psychological Disorders and BPSD Behavior
Behavioral and psycological symptoms of dementia, (BPSD) are one of the major problem for families, doctors and for patients the same. To reduce the side effects of the standard treatments, is important to find an alternative methods of treatment, eg the aromatherapy. There is an incresing in scientific evidence the its use in dementia behavior related.
Read the detailed description
Behavioral and psycological symptoms of dementia, (BPSD) are one of the major problem for families, doctors and for patients the same.
In absence of the universally recognized guidelines, the standard treatment involves the use of psychotropic drugs (typical / atypical neuroleptics, antidepressants, benzodiazepines) that are often not very effective and involve a series of side effects such as sedation, slowing down -motor with impaired cognitive performance, cardiac electrical changes and extrapyramidal syndrome. In view of this, it is important to find an alternative methods of treatment, which can reduce psychological and behavioral disorders and at the same time the use of psychotropic drugs.
As for aromatherapy, ie the therapeutic use of natural essential oils, there is a decades-long clinical experience, especially in France, which is accompanied by increasing scientific evidence with considerable increase in publications in its use in psychological disorders and dementia behavior related. Based on the scientific publications available, it was therefore decided to use two essential oils (Citrus sinensis, Lavandula angustifolia) in environmental diffusion in the Geriatric Department of the Clinica Luganese Moncucco.
- Being tested
- essential oils
- Keywords
- BPSD (behavioral and psycological symptoms of dementia), aromatherapy, elderly
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
essential oilsOther
Also called lavander essential oil, wild orange essential oil
Following a specific schema, the randomization will be perfomed. Patients enrolled in Group B will receive in environmental diffusion two essential oils, to define their possible effectiveness in the control of the psychological and behavioural disorders
| Study group | Role | What they receive |
|---|---|---|
| GROUP A - control group | No intervention | 16 patients who respect the inclusion criteria, treated with psychotropic drugs Pro Re Nata. |
| GROUP B - aromatherapy group | Experimental | 16 patients included in the inclusion criteria, treated with psychotropic drugs Pro Re Nata and, in a complementary way, with diffusion aromatherapy Receives: Other: essential oils |
What is being measured
The primary outcome is the main question the study is designed to answer.
Role of Essential Oil Therapy in Environmental Diffusion as a Complement of Psychotropic Drugs in the Management of Psychological and Behavioral Disorders (BPSD)
The Neuropsychiatric Inventory - Nursing Home Version (NPI-NH) test will characterize the neuropsychiatric and psychopathological symptoms of patients affected by dementia.
Events as delirium, anxiety, depression, etc. will be recorded by the frequency (from 0, absence, to 4, high frequency) and the seriousness (from 0, absence, to 3, high). The total score of the NPI-NH is given by the frequency x (multiply) seriousness (total score for each event has a range from 0 to 12). The patient final score will be given by the sum of the score of the 12 events. For each patient will be given a total score from 0 to 144.
NPI NH score has been collected in both control and aromatherapy groups at T1 and T3, in patients who needed and who did not needed Pro Re Nata.
Measured: Time 1 (baseline) and Time 3 (day 7)
Secondary outcomes (1)
Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD
NPI-NH assess the psychological distress in physicians, nurses and nursing assistants who managed the patients. It has a score from 0 (no discomfort) to score of 5 (extreme discomfort). The psychological distress is measured for each of the 12 events in the NPI-NH scale, for a total score from 0 to 60.
Measured: Time 1 (baseline) and Time 3 (day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start20 May 2018
- Primary completion30 Jun 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for BPSD (Behavioral and Psycological Symptoms of Dementia)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The enrolled patients will be randomized following the 4 blocks random schema (AABB, ABAB, BBAA, BABA, ABBA, BAAB). A repetition of the first 4 blocks will be perform up to 32 patients: AABB, ABAB, BBAA, BABA AABB, ABAB, BBAA, BABA
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Luganese Moncucco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pio Eugenio Fontana, Clinica Luganese Moncucco
- Investigators
- Alessandra Franzetti Pellanda, MD, Study director, Clinica Luganese MoncuccoPio Eugenio Fontana, MD, Study director, Clinica Luganese Moncucco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662360
- Sponsor's protocol ID
- CLM_ds_p_02
- Status last verified
- Sep 2021
- First submitted
- 7 Jun 2018
- Last updated
- 30 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A UPN will be attributed to each patient. The dataset containing the correspondence between the UPN and the patient's personal and clinical data will be kept at the Clinical Research Unit of the Clinica Luganese Moncucco. All the analyzed data that will be published or available for scientific discussions will be codified.
Publications
Ballard CG, Gauthier S, Cummings JL, Brodaty H, Grossberg GT, Robert P, Lyketsos CG. Management of agitation and aggression associated with Alzheimer disease. Nat Rev Neurol. 2009 May;5(5):245-55. doi: 10.1038/nrneurol.2009.39.
PubMed 19488082Margallo-Lana M, Swann A, O'Brien J, Fairbairn A, Reichelt K, Potkins D, Mynt P, Ballard C. Prevalence and pharmacological management of behavioural and psychological symptoms amongst dementia sufferers living in care environments. Int J Geriatr Psychiatry. 2001 Jan;16(1):39-44. doi: 10.1002/1099-1166(200101)16:13.0.co;2-f.
PubMed 11180484Lonergan E, Luxenberg J, Colford J. Haloperidol for agitation in dementia. Cochrane Database Syst Rev. 2002;(2):CD002852. doi: 10.1002/14651858.CD002852.
PubMed 12076456Ballard C, Corbett A. Agitation and aggression in people with Alzheimer's disease. Curr Opin Psychiatry. 2013 May;26(3):252-9. doi: 10.1097/YCO.0b013e32835f414b.
PubMed 23528917Ballard C, Howard R. Neuroleptic drugs in dementia: benefits and harm. Nat Rev Neurosci. 2006 Jun;7(6):492-500. doi: 10.1038/nrn1926.
PubMed 16715057Schneider LS, Dagerman K, Insel PS. Efficacy and adverse effects of atypical antipsychotics for dementia: meta-analysis of randomized, placebo-controlled trials. Am J Geriatr Psychiatry. 2006 Mar;14(3):191-210. doi: 10.1097/01.JGP.0000200589.01396.6d.
PubMed 16505124Schneider LS, Tariot PN, Dagerman KS, Davis SM, Hsiao JK, Ismail MS, Lebowitz BD, Lyketsos CG, Ryan JM, Stroup TS, Sultzer DL, Weintraub D, Lieberman JA; CATIE-AD Study Group. Effectiveness of atypical antipsychotic drugs in patients with Alzheimer's disease. N Engl J Med. 2006 Oct 12;355(15):1525-38. doi: 10.1056/NEJMoa061240.
PubMed 17035647Ballard C, Hanney ML, Theodoulou M, Douglas S, McShane R, Kossakowski K, Gill R, Juszczak E, Yu LM, Jacoby R; DART-AD investigators. The dementia antipsychotic withdrawal trial (DART-AD): long-term follow-up of a randomised placebo-controlled trial. Lancet Neurol. 2009 Feb;8(2):151-7. doi: 10.1016/S1474-4422(08)70295-3. Epub 2009 Jan 8.
PubMed 19138567Ballard CG, O'Brien JT, Reichelt K, Perry EK. Aromatherapy as a safe and effective treatment for the management of agitation in severe dementia: the results of a double-blind, placebo-controlled trial with Melissa. J Clin Psychiatry. 2002 Jul;63(7):553-8. doi: 10.4088/jcp.v63n0703.
PubMed 12143909Holmes C, Hopkins V, Hensford C, MacLaughlin V, Wilkinson D, Rosenvinge H. Lavender oil as a treatment for agitated behaviour in severe dementia: a placebo controlled study. Int J Geriatr Psychiatry. 2002 Apr;17(4):305-8. doi: 10.1002/gps.593.
PubMed 11994882O'Connor DW, Eppingstall B, Taffe J, van der Ploeg ES. A randomized, controlled cross-over trial of dermally-applied lavender (Lavandula angustifolia) oil as a treatment of agitated behaviour in dementia. BMC Complement Altern Med. 2013 Nov 13;13:315. doi: 10.1186/1472-6882-13-315.
PubMed 24219098Jimbo D, Kimura Y, Taniguchi M, Inoue M, Urakami K. Effect of aromatherapy on patients with Alzheimer's disease. Psychogeriatrics. 2009 Dec;9(4):173-9. doi: 10.1111/j.1479-8301.2009.00299.x.
PubMed 20377818Elisabetsky E, Marschner J, Souza DO. Effects of Linalool on glutamatergic system in the rat cerebral cortex. Neurochem Res. 1995 Apr;20(4):461-5. doi: 10.1007/BF00973103.
PubMed 7651584Huang L, Abuhamdah S, Howes MJ, Dixon CL, Elliot MS, Ballard C, Holmes C, Burns A, Perry EK, Francis PT, Lees G, Chazot PL. Pharmacological profile of essential oils derived from Lavandula angustifolia and Melissa officinalis with anti-agitation properties: focus on ligand-gated channels. J Pharm Pharmacol. 2008 Nov;60(11):1515-22. doi: 10.1211/jpp/60.11.0013.
PubMed 18957173Kim JT, Ren CJ, Fielding GA, Pitti A, Kasumi T, Wajda M, Lebovits A, Bekker A. Treatment with lavender aromatherapy in the post-anesthesia care unit reduces opioid requirements of morbidly obese patients undergoing laparoscopic adjustable gastric banding. Obes Surg. 2007 Jul;17(7):920-5. doi: 10.1007/s11695-007-9170-7.
PubMed 17894152
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elderly Patients With Dementia in the Department of Acute Geriatrics: Pilot Study, Monocentric, Randomized Use of Aromatherapy as a Complementary Treatment to Psychopharmacotherapy in Psychological Disorders and BPSD Behavior
- ClinicalTrials.gov ID
- NCT03662360
- Acronym / sponsor ID
- CLM_ds_p_02
- Keywords
- BPSD (behavioral and psycological symptoms of dementia), aromatherapy, elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Clinica Luganese MoncuccoUniversity, hospital or other
- Study start
- 20 May 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 7 Sep 2018 (actual)
- Results
- Posted 30 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Behavioral and psycological symptoms of dementia, (BPSD) are one of the major problem for families, doctors and for patients the same. To reduce the side effects of the standard treatments, is important to find an alternative methods of treatment, eg the aromatherapy. There is an incresing in scientific evidence the its use in dementia behavior related.
Detailed description
Behavioral and psycological symptoms of dementia, (BPSD) are one of the major problem for families, doctors and for patients the same.
In absence of the universally recognized guidelines, the standard treatment involves the use of psychotropic drugs (typical / atypical neuroleptics, antidepressants, benzodiazepines) that are often not very effective and involve a series of side effects such as sedation, slowing down -motor with impaired cognitive performance, cardiac electrical changes and extrapyramidal syndrome. In view of this, it is important to find an alternative methods of treatment, which can reduce psychological and behavioral disorders and at the same time the use of psychotropic drugs.
As for aromatherapy, ie the therapeutic use of natural essential oils, there is a decades-long clinical experience, especially in France, which is accompanied by increasing scientific evidence with considerable increase in publications in its use in psychological disorders and dementia behavior related. Based on the scientific publications available, it was therefore decided to use two essential oils (Citrus sinensis, Lavandula angustifolia) in environmental diffusion in the Geriatric Department of the Clinica Luganese Moncucco.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The enrolled patients will be randomized following the 4 blocks random schema (AABB, ABAB, BBAA, BABA, ABBA, BAAB). A repetition of the first 4 blocks will be perform up to 32 patients: AABB, ABAB, BBAA, BABA AABB, ABAB, BBAA, BABA
| Arm | Type | Receives |
|---|---|---|
| GROUP A - control group | No intervention | –16 patients who respect the inclusion criteria, treated with psychotropic drugs Pro Re Nata. |
| GROUP B - aromatherapy group | Experimental | Other: essential oils16 patients included in the inclusion criteria, treated with psychotropic drugs Pro Re Nata and, in a complementary way, with diffusion aromatherapy |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- patients admitted to the acute geriatric ward;
- patients with a known diagnosis of dementia associated with BPSD or diagnosis performed during hospitalization.
Key exclusion criteria (4 listed)
- patients with alcohol-based dementia;
- patients with Mild Cognitive Impairment (MCI) - section 4 -;
- patients with language barrier;
- patients already being treated with aromatherapy.
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 |
|---|---|---|
| essential oilsAlso: lavander essential oil, wild orange essential oilFollowing a specific schema, the randomization will be perfomed. Patients enrolled in Group B will receive in environmental diffusion two essential oils, to define their possible effectiveness in the control of the psychological and behavioural disorders | Other | GROUP B - aromatherapy group |
Primary outcome
Role of Essential Oil Therapy in Environmental Diffusion as a Complement of Psychotropic Drugs in the Management of Psychological and Behavioral Disorders (BPSD)
Time frame: Time 1 (baseline) and Time 3 (day 7)
The Neuropsychiatric Inventory - Nursing Home Version (NPI-NH) test will characterize the neuropsychiatric and psychopathological symptoms of patients affected by dementia. Events as delirium, anxiety, depression, etc. will be recorded by the frequency (from 0, absence, to 4, high frequency) and the seriousness (from 0, absence, to 3, high). The total score of the NPI-NH is given by the frequency x (multiply) seriousness (total score for each event has a range from 0 to 12). The patient final score will be given by the sum of the score of the 12 events. For each patient will be given a total score from 0 to 144. NPI NH score has been collected in both control and aromatherapy groups at T1 and T3, in patients who needed and who did not needed Pro Re Nata.
1 secondary outcome
Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD
Time frame: Time 1 (baseline) and Time 3 (day 7)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19488082Ballard CG, Gauthier S, Cummings JL, Brodaty H, Grossberg GT, Robert P, Lyketsos CG. Management of agitation and aggression associated with Alzheimer disease. Nat Rev Neurol. 2009 May;5(5):245-55. doi: 10.1038/nrneurol.2009.39.
- Background: PubMed 11180484Margallo-Lana M, Swann A, O'Brien J, Fairbairn A, Reichelt K, Potkins D, Mynt P, Ballard C. Prevalence and pharmacological management of behavioural and psychological symptoms amongst dementia sufferers living in care environments. Int J Geriatr Psychiatry. 2001 Jan;16(1):39-44. doi: 10.1002/1099-1166(200101)16:13.0.co;2-f.
- Background: PubMed 12076456Lonergan E, Luxenberg J, Colford J. Haloperidol for agitation in dementia. Cochrane Database Syst Rev. 2002;(2):CD002852. doi: 10.1002/14651858.CD002852.
- Background: PubMed 23528917Ballard C, Corbett A. Agitation and aggression in people with Alzheimer's disease. Curr Opin Psychiatry. 2013 May;26(3):252-9. doi: 10.1097/YCO.0b013e32835f414b.
- Background: PubMed 16715057Ballard C, Howard R. Neuroleptic drugs in dementia: benefits and harm. Nat Rev Neurosci. 2006 Jun;7(6):492-500. doi: 10.1038/nrn1926.
- Background: PubMed 16505124Schneider LS, Dagerman K, Insel PS. Efficacy and adverse effects of atypical antipsychotics for dementia: meta-analysis of randomized, placebo-controlled trials. Am J Geriatr Psychiatry. 2006 Mar;14(3):191-210. doi: 10.1097/01.JGP.0000200589.01396.6d.
- Background: PubMed 17035647Schneider LS, Tariot PN, Dagerman KS, Davis SM, Hsiao JK, Ismail MS, Lebowitz BD, Lyketsos CG, Ryan JM, Stroup TS, Sultzer DL, Weintraub D, Lieberman JA; CATIE-AD Study Group. Effectiveness of atypical antipsychotic drugs in patients with Alzheimer's disease. N Engl J Med. 2006 Oct 12;355(15):1525-38. doi: 10.1056/NEJMoa061240.
- Background: PubMed 19138567Ballard C, Hanney ML, Theodoulou M, Douglas S, McShane R, Kossakowski K, Gill R, Juszczak E, Yu LM, Jacoby R; DART-AD investigators. The dementia antipsychotic withdrawal trial (DART-AD): long-term follow-up of a randomised placebo-controlled trial. Lancet Neurol. 2009 Feb;8(2):151-7. doi: 10.1016/S1474-4422(08)70295-3. Epub 2009 Jan 8.
- Background: PubMed 12143909Ballard CG, O'Brien JT, Reichelt K, Perry EK. Aromatherapy as a safe and effective treatment for the management of agitation in severe dementia: the results of a double-blind, placebo-controlled trial with Melissa. J Clin Psychiatry. 2002 Jul;63(7):553-8. doi: 10.4088/jcp.v63n0703.
- Background: PubMed 11994882Holmes C, Hopkins V, Hensford C, MacLaughlin V, Wilkinson D, Rosenvinge H. Lavender oil as a treatment for agitated behaviour in severe dementia: a placebo controlled study. Int J Geriatr Psychiatry. 2002 Apr;17(4):305-8. doi: 10.1002/gps.593.
- Background: PubMed 24219098O'Connor DW, Eppingstall B, Taffe J, van der Ploeg ES. A randomized, controlled cross-over trial of dermally-applied lavender (Lavandula angustifolia) oil as a treatment of agitated behaviour in dementia. BMC Complement Altern Med. 2013 Nov 13;13:315. doi: 10.1186/1472-6882-13-315.
- Background: PubMed 20377818Jimbo D, Kimura Y, Taniguchi M, Inoue M, Urakami K. Effect of aromatherapy on patients with Alzheimer's disease. Psychogeriatrics. 2009 Dec;9(4):173-9. doi: 10.1111/j.1479-8301.2009.00299.x.
- details about mild cognitive impairmentLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. A UPN will be attributed to each patient. The dataset containing the correspondence between the UPN and the patient's personal and clinical data will be kept at the Clinical Research Unit of the Clinica Luganese Moncucco. All the analyzed data that will be published or available for scientific discussions will be codified.
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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.
Alessandra Franzetti Pellanda, MD study director
Clinica Luganese Moncucco
Pio Eugenio Fontana, MD study director
Clinica Luganese Moncucco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing essential oils in people with BPSD (Behavioral and Psycological Symptoms of Dementia), run by Clinica Luganese Moncucco at 1 site in Switzerland.
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 2 inclusion and 4 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 30 Sep 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 Switzerland. 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?
Yes. Results are posted in the registry (first posted 30 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Role of Essential Oil Therapy in Environmental Diffusion as a Complement of Psychotropic Drugs in the Management of Psychological and Behavioral Disorders (BPSD) (time frame: Time 1 (baseline) and Time 3 (day 7)). 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 NCT03662360, which also lists 25 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 30 Sep 2021.