Severe DementiaBEONCT04321889
Efficacy of Defurocumarinized Bergamot in the Treatment of Agitation in Severe Dementia Patients.
A study testing defurocumarinized bergamot loaded in a nanotechnological essential oil release system in people with Severe Dementia and Stroke, run by S.Anna Rehabilitation Institute.
Trial summary
This study evaluates the efficacy of defurocumarinized bergamot in the treatment of agitation in severe dementia patients. Bergamot essential oil (BEO), able to modulate the endogenous, peripheral and central opioid system involved in painful states, has developed in models of inflammatory pain and neuropathic pain… Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Severe Dementia, Stroke
- What is being tested?
- defurocumarinized bergamot loaded in a nanotechnological essential oil release system
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 30 Jun 2021
- 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 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Diagnosis of severe dementia by MMSE score<12;
- Signature of informed consent by a family member/caregiver/support administrator;
- The use of authorised and concomitant therapies for the treatment of agitation is permitted.
Who cannot join
- -Positive remote case history for pre-existing neurological or psychiatric disabling conditions
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized Double-blind Controlled Trial to Evaluate the Efficacy of Defurocumarinized Bergamot Loaded in a Nanotechnological System for the Release of Essential Oil in the Treatment of Agitation in Severe Dementia Patients.
This study evaluates the efficacy of defurocumarinized bergamot in the treatment of agitation in severe dementia patients. Bergamot essential oil (BEO), able to modulate the endogenous, peripheral and central opioid system involved in painful states, has developed in models of inflammatory pain and neuropathic pain; it is also effective when administered by inhalation.
Participants in the study will be divided into 2 parallel groups, one treatment group and one placebo, to evaluate the clinical efficacy of defurocumarinized bergamot loaded in a nanotechnological system of essential oil release in the pharmaceutical form of a cream in the treatment of agitation, in in Over-sixty-five-year-old patients of both sexes diagnosed with severe dementia.
Read the detailed description
According to the World Alzheimer's Report 2018, 50 million people worldwide suffer from dementia and it is estimated that this number will triple by 2050.
Very often people with dementia suffer from comorbidities accompanied by chronic, inflammatory and neuropathic pain, often under-diagnosed through psychological and behavioral symptoms of dementia such as agitation and aggression. The therapy of neuropsychiatric symptoms of dementia is currently based on the use of atypical antipsychotics that are actually present in the short term and may induce important side effects.
This study evaluates the efficacy of defurocumarinized bergamot in the treatment of agitation in severe dementia patients. Bergamot essential oil (BEO), able to modulate the endogenous, peripheral and central opioid system involved in painful states, has developed in models of inflammatory pain and neuropathic pain; it is also effective when administered by inhalation. To solve this problem, this clinical trial will use defurocumarinized bergamot loaded in a nanotechnological system of essential oil release in the pharmaceutical form of an odourless cream indistinguishable from placebo cream.
Participants in the study will be divided into 2 parallel groups, one treatment group and one placebo, to evaluate the clinical efficacy of defurocumarinized bergamot loaded in a nanotechnological system of essential oil release in the pharmaceutical form of a cream in the treatment of agitation, in in Over-sixty-five-year-old patients of both sexes diagnosed with severe dementia.
The rationale of this clinical trial is based on three fundamental points:
- Preclinical research has proven, beyond any doubt, a powerful analgesic activity of BEO on inflammatory and neuropathic pain;
- at present the essential oils needed in aromatherapy for agitation management do not show strong analgesic activity, documented by extensive preclinical evidence;
- clinical trials that have assessed the efficacy of aromatherapy in neuropsychiatric symptoms associated with dementia suffer from the severe lack of a double-blind according to the most rigorous criteria of clinical trial evaluation. To solve this problem, this clinical trial will use defurocumarinized bergamot loaded in a nanotechnological system of essential oil release in the pharmaceutical form of an odourless cream indistinguishable from placebo cream.
- Conditions
- Severe Dementia, Stroke
- Being tested
- defurocumarinized bergamot loaded in a nanotechnological essential oil release system, Placebo
- Medical subject headings
- Dementia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
defurocumarinized bergamot loaded in a nanotechnological essential oil release systemDevice
Patients will be treated either with placebo cream or with defurocumarinized bergamot loaded in a nanotechnological system of essential oil release in the pharmaceutical form of cream 2 times a day for 4 weeks. The subject will be monitored throughout the treatment and for at least 4 weeks after the end of the treatment.
PlaceboOther
nanotechnological system loaded with placebo cream
| Study group | Role | What they receive |
|---|---|---|
| BEO | Experimental | Subjects of both sexes of age >65 years who have received diagnosis of severe dementia and clinically relevant agitation hospitalized in the enrolment center. Receives: Device: defurocumarinized bergamot loaded in a nanotechnological essential oil release system |
| Placebo | Placebo comparator | Subjects of both sexes of age >65 years who have received diagnosis of severe dementia and clinically relevant agitation hospitalized in the enrolment center. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of agitation
To evaluate the clinical efficacy of defurocumarinized bergamot l in the treatment of agitation in patients with severe dementia by determination of the Cohen-Mansfield Agitation Inventory (CMAI)score. CMAI is a 29-item scale widely used to assess agitation.
Measured: up to 6 weeks after the end of treatment
Secondary outcomes (2)
Duration of the effect on agitation
Carry out a follow-up following suspension of the treatment with defurocumarinized bergamot loaded in a nanotechnology essential oil release system to assess the duration of the effect on agitation, using Cohen-Mansfield Agitation Inventory (CMAI) score. CMAI is a 29-item scale widely used to assess agitation.
Measured: 6 weeks after the end of treatment
clinical efficacy on pain
Determine the clinical efficacy of defurocumarinized bergamot, loaded in a nanotechnological system of essential oil release in the pharmaceutical form of a cream, on pain in patients with severe dementia by determining the weekly score of the Mobilization-Observation-Behaviour-Intensity-Dementia (MOBID)-2 pain assessment scale. MOBID-2 is an extended version of the MOBID pain scale and consists of two parts: Part 1 is the previous MOBID and is used for the assessment of musculoskeletal pain through the observation of painful behaviour when performing five guided movements of different parts of the body in order to assign a score to the pain intensity; Part 2 is used for the assessment of pain from internal organs, head and skin, through behavioural indicators of pain and pain localization on the pain site illustrations.
Measured: 6 weeks after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start1 Apr 2020 (estimated)
- Primary completion10 Dec 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Severe DementiaStudies 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
- Randomized double-blind placebo clinical trial for parallel groups to evaluate the clinical efficacy of defurocumarinized bergamot loaded in a nanotechnological system of essential oil release in the pharmaceutical form of a cream in the treatment of agitation, in patients of both sexes with severe dementia diagnosis. Subjects will be eligible if they meet all inclusion criteria. A total of 134 patients will be enrolled, randomized, in a 1:1 ratio, to treatment with defurocumarinized bergamot loaded in a nanotechnological release system or placebo.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- S.Anna Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paolo Tonin, MD, Principal investigator, S.Anna Rehabilitation Insitute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321889
- Sponsor's protocol ID
- ISA-BEO092019
- Acronym
- BEO
- Status last verified
- Mar 2020
- First submitted
- 10 Mar 2020
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual partecipant data for all primary and secondary outcome measures will be made available
Publications
Scuteri D, Rombola L, Morrone LA, Bagetta G, Sakurada S, Sakurada T, Tonin P, Corasaniti MT. Neuropharmacology of the Neuropsychiatric Symptoms of Dementia and Role of Pain: Essential Oil of Bergamot as a Novel Therapeutic Approach. Int J Mol Sci. 2019 Jul 6;20(13):3327. doi: 10.3390/ijms20133327.
PubMed 31284573Scuteri D, Morrone LA, Rombola L, Avato PR, Bilia AR, Corasaniti MT, Sakurada S, Sakurada T, Bagetta G. Aromatherapy and Aromatic Plants for the Treatment of Behavioural and Psychological Symptoms of Dementia in Patients with Alzheimer's Disease: Clinical Evidence and Possible Mechanisms. Evid Based Complement Alternat Med. 2017;2017:9416305. doi: 10.1155/2017/9416305. Epub 2017 Mar 30.
PubMed 28465709Scuteri D, Crudo M, Rombola L, Watanabe C, Mizoguchi H, Sakurada S, Sakurada T, Greco R, Corasaniti MT, Morrone LA, Bagetta G. Antinociceptive effect of inhalation of the essential oil of bergamot in mice. Fitoterapia. 2018 Sep;129:20-24. doi: 10.1016/j.fitote.2018.06.007. Epub 2018 Jun 12.
PubMed 29906556Sakurada T, Mizoguchi H, Kuwahata H, Katsuyama S, Komatsu T, Morrone LA, Corasaniti MT, Bagetta G, Sakurada S. Intraplantar injection of bergamot essential oil induces peripheral antinociception mediated by opioid mechanism. Pharmacol Biochem Behav. 2011 Jan;97(3):436-43. doi: 10.1016/j.pbb.2010.09.020. Epub 2010 Oct 13.
PubMed 20932858Sakurada T, Kuwahata H, Katsuyama S, Komatsu T, Morrone LA, Corasaniti MT, Bagetta G, Sakurada S. Intraplantar injection of bergamot essential oil into the mouse hindpaw: effects on capsaicin-induced nociceptive behaviors. Int Rev Neurobiol. 2009;85:237-48. doi: 10.1016/S0074-7742(09)85018-6.
PubMed 19607974Berliocchi L, Russo R, Maiaru M, Levato A, Bagetta G, Corasaniti MT. Autophagy impairment in a mouse model of neuropathic pain. Mol Pain. 2011 Oct 24;7:83. doi: 10.1186/1744-8069-7-83.
PubMed 22023914Scuteri D, Pagliaro M, Mantia I, Contrada M, Pignolo L, Tonin P, Nicotera P, Bagetta G, Corasaniti MT; Pilot BRAINAID Trial investigators. Efficacy of therapeutic intervention with NanoBEO to manage agitation and pain in patients suffering from severe dementia: a pilot clinical trial. Front Pharmacol. 2024 Aug 1;15:1417851. doi: 10.3389/fphar.2024.1417851. eCollection 2024.
PubMed 39148533Scuteri D, Sakurada S, Sakurada T, Tonin P, Bagetta G, Nicotera P, Corasaniti MT. Requirements for Translation in Clinical Trials of Aromatherapy: The Case of the Essential Oil of Bergamot (BEO) for Management of Agitation in Severe Dementia. Curr Pharm Des. 2022;28(20):1607-1610. doi: 10.2174/1381612828666220509152029.
PubMed 35579159
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Controlled Trial to Evaluate the Efficacy of Defurocumarinized Bergamot Loaded in a Nanotechnological System for the Release of Essential Oil in the Treatment of Agitation in Severe Dementia Patients.
- ClinicalTrials.gov ID
- NCT04321889
- Acronym / sponsor ID
- BEO / ISA-BEO092019
- Conditions
- Severe Dementia, Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- S.Anna Rehabilitation InstituteUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 10 Dec 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 25 Mar 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.
This study evaluates the efficacy of defurocumarinized bergamot in the treatment of agitation in severe dementia patients. Bergamot essential oil (BEO), able to modulate the endogenous, peripheral and central opioid system involved in painful states, has developed in models of inflammatory pain and neuropathic pain; it is also effective when administered by inhalation.
Participants in the study will be divided into 2 parallel groups, one treatment group and one placebo, to evaluate the clinical efficacy of defurocumarinized bergamot loaded in a nanotechnological system of essential oil release in the pharmaceutical form of a cream in the treatment of agitation, in in Over-sixty-five-year-old patients of both sexes diagnosed with severe dementia.
Detailed description
According to the World Alzheimer's Report 2018, 50 million people worldwide suffer from dementia and it is estimated that this number will triple by 2050.
Very often people with dementia suffer from comorbidities accompanied by chronic, inflammatory and neuropathic pain, often under-diagnosed through psychological and behavioral symptoms of dementia such as agitation and aggression. The therapy of neuropsychiatric symptoms of dementia is currently based on the use of atypical antipsychotics that are actually present in the short term and may induce important side effects.
This study evaluates the efficacy of defurocumarinized bergamot in the treatment of agitation in severe dementia patients. Bergamot essential oil (BEO), able to modulate the endogenous, peripheral and central opioid system involved in painful states, has developed in models of inflammatory pain and neuropathic pain; it is also effective when administered by inhalation. To solve this problem, this clinical trial will use defurocumarinized bergamot loaded in a nanotechnological system of essential oil release in the pharmaceutical form of an odourless cream indistinguishable from placebo cream.
Participants in the study will be divided into 2 parallel groups, one treatment group and one placebo, to evaluate the clinical efficacy of defurocumarinized bergamot loaded in a nanotechnological system of essential oil release in the pharmaceutical form of a cream in the treatment of agitation, in in Over-sixty-five-year-old patients of both sexes diagnosed with severe dementia.
The rationale of this clinical trial is based on three fundamental points:
- Preclinical research has proven, beyond any doubt, a powerful analgesic activity of BEO on inflammatory and neuropathic pain;
- at present the essential oils needed in aromatherapy for agitation management do not show strong analgesic activity, documented by extensive preclinical evidence;
- clinical trials that have assessed the efficacy of aromatherapy in neuropsychiatric symptoms associated with dementia suffer from the severe lack of a double-blind according to the most rigorous criteria of clinical trial evaluation. To solve this problem, this clinical trial will use defurocumarinized bergamot loaded in a nanotechnological system of essential oil release in the pharmaceutical form of an odourless cream indistinguishable from placebo cream.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double-blind placebo clinical trial for parallel groups to evaluate the clinical efficacy of defurocumarinized bergamot loaded in a nanotechnological system of essential oil release in the pharmaceutical form of a cream in the treatment of agitation, in patients of both sexes with severe dementia diagnosis. Subjects will be eligible if they meet all inclusion criteria. A total of 134 patients will be enrolled, randomized, in a 1:1 ratio, to treatment with defurocumarinized bergamot loaded in a nanotechnological release system or placebo.
| Arm | Type | Receives |
|---|---|---|
| BEO | Experimental | Device: defurocumarinized bergamot loaded in a nanotechnological essential oil release systemSubjects of both sexes of age >65 years who have received diagnosis of severe dementia and clinically relevant agitation hospitalized in the enrolment center. |
| Placebo | Placebo comparator | Other: PlaceboSubjects of both sexes of age >65 years who have received diagnosis of severe dementia and clinically relevant agitation hospitalized in the enrolment center. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Diagnosis of severe dementia by MMSE score<12;
- Signature of informed consent by a family member/caregiver/support administrator;
- The use of authorised and concomitant therapies for the treatment of agitation is permitted.
Key exclusion criteria (1 listed)
- -Positive remote case history for pre-existing neurological or psychiatric disabling conditions
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 |
|---|---|---|
| defurocumarinized bergamot loaded in a nanotechnological essential oil release systemPatients will be treated either with placebo cream or with defurocumarinized bergamot loaded in a nanotechnological system of essential oil release in the pharmaceutical form of cream 2 times a day for 4 weeks. The subject will be monitored throughout the treatment and for at least 4 weeks after the end of the treatment. | Device | BEO |
| Placebonanotechnological system loaded with placebo cream | Other | Placebo |
Primary outcome
Treatment of agitation
Time frame: up to 6 weeks after the end of treatment
To evaluate the clinical efficacy of defurocumarinized bergamot l in the treatment of agitation in patients with severe dementia by determination of the Cohen-Mansfield Agitation Inventory (CMAI)score. CMAI is a 29-item scale widely used to assess agitation.
2 secondary outcomes
Duration of the effect on agitation
Time frame: 6 weeks after the end of treatment
clinical efficacy on pain
Time frame: 6 weeks after the end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Background: PubMed 31284573Scuteri D, Rombola L, Morrone LA, Bagetta G, Sakurada S, Sakurada T, Tonin P, Corasaniti MT. Neuropharmacology of the Neuropsychiatric Symptoms of Dementia and Role of Pain: Essential Oil of Bergamot as a Novel Therapeutic Approach. Int J Mol Sci. 2019 Jul 6;20(13):3327. doi: 10.3390/ijms20133327.
- Background: PubMed 28465709Scuteri D, Morrone LA, Rombola L, Avato PR, Bilia AR, Corasaniti MT, Sakurada S, Sakurada T, Bagetta G. Aromatherapy and Aromatic Plants for the Treatment of Behavioural and Psychological Symptoms of Dementia in Patients with Alzheimer's Disease: Clinical Evidence and Possible Mechanisms. Evid Based Complement Alternat Med. 2017;2017:9416305. doi: 10.1155/2017/9416305. Epub 2017 Mar 30.
- Background: PubMed 29906556Scuteri D, Crudo M, Rombola L, Watanabe C, Mizoguchi H, Sakurada S, Sakurada T, Greco R, Corasaniti MT, Morrone LA, Bagetta G. Antinociceptive effect of inhalation of the essential oil of bergamot in mice. Fitoterapia. 2018 Sep;129:20-24. doi: 10.1016/j.fitote.2018.06.007. Epub 2018 Jun 12.
- Background: PubMed 20932858Sakurada T, Mizoguchi H, Kuwahata H, Katsuyama S, Komatsu T, Morrone LA, Corasaniti MT, Bagetta G, Sakurada S. Intraplantar injection of bergamot essential oil induces peripheral antinociception mediated by opioid mechanism. Pharmacol Biochem Behav. 2011 Jan;97(3):436-43. doi: 10.1016/j.pbb.2010.09.020. Epub 2010 Oct 13.
- Background: PubMed 19607974Sakurada T, Kuwahata H, Katsuyama S, Komatsu T, Morrone LA, Corasaniti MT, Bagetta G, Sakurada S. Intraplantar injection of bergamot essential oil into the mouse hindpaw: effects on capsaicin-induced nociceptive behaviors. Int Rev Neurobiol. 2009;85:237-48. doi: 10.1016/S0074-7742(09)85018-6.
- Background: PubMed 22023914Berliocchi L, Russo R, Maiaru M, Levato A, Bagetta G, Corasaniti MT. Autophagy impairment in a mouse model of neuropathic pain. Mol Pain. 2011 Oct 24;7:83. doi: 10.1186/1744-8069-7-83.
- Derived from this study: PubMed 39148533Scuteri D, Pagliaro M, Mantia I, Contrada M, Pignolo L, Tonin P, Nicotera P, Bagetta G, Corasaniti MT; Pilot BRAINAID Trial investigators. Efficacy of therapeutic intervention with NanoBEO to manage agitation and pain in patients suffering from severe dementia: a pilot clinical trial. Front Pharmacol. 2024 Aug 1;15:1417851. doi: 10.3389/fphar.2024.1417851. eCollection 2024.
- Derived from this study: PubMed 35579159Scuteri D, Sakurada S, Sakurada T, Tonin P, Bagetta G, Nicotera P, Corasaniti MT. Requirements for Translation in Clinical Trials of Aromatherapy: The Case of the Essential Oil of Bergamot (BEO) for Management of Agitation in Severe Dementia. Curr Pharm Des. 2022;28(20):1607-1610. doi: 10.2174/1381612828666220509152029.
- Individual participant dataSharing planned: Yes. De-identified individual partecipant data for all primary and secondary outcome measures will be made available
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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.
Paolo Tonin, MD principal investigator
S.Anna Rehabilitation Insitute
Questions about this trial
What is this clinical trial studying?
A study testing defurocumarinized bergamot loaded in a nanotechnological essential oil release system in people with Severe Dementia and Stroke, run by S.Anna Rehabilitation Institute.
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 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Loris Pignolo, Researcher (3996223973, l.pignolo@isakr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment of agitation (time frame: up to 6 weeks after the end of treatment). 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 NCT04321889, which also lists 8 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 25 Mar 2020.