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
Phase: NA
Conditions: BPSD (Behavioral and Psycological Symptoms of Dementia)
Sponsor: Clinica Luganese Moncucco

 
 
 
 
 
 
 
 
 
 
 
   
 
 
The elderly patient demented in an acute geriatric department: pilot study, monocentric, 
randomized on the use of aromatherapy as a complementary treatment tool to 
psychopharmacology in behavioral and psycological symptoms of dementia (BPSD) 
 
Protocol version: n.3, 23 of April 2018 
 
Activation date: May 2018 
 
NCT03662360 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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INDEX  
 
1. Synopsis 
 
 
 
 
 
 
pag. 4 
2. Flow chart  
 
 
 
 
 
pag. 7 
3. Study characteristics 
 
 
 
             pag. 9 
4. Protocol rationale  
 
 
 
 
pag. 9 
5. Study population  
 
 
 
 
pag. 10 
6. Project objectives  
 
 
 
 
pag. 12 
7. Randomization 
 
 
 
 
 
pag. 13 
8. Project design 
 
 
 
 
 
pag. 13 
9. Eligibility criteria 
 
 
 
 
 
pag. 15 
10. Codify and registration procedures 
 
 
pag. 15 
11. Project duration 
 
 
 
 
 
pag. 15 
12. Risks and benefits   
 
 
 
 
pag. 15 
13. Statistical considerations  
 
 
 
pag. 16 
14. Ethical considerations  
 
 
 
 
pag. 16 
15. Data publishing policy 
 
 
 
 
pag. 16 
16. Insurance coverage  
 
 
 
 
pag. 16 
17. Funding 
 
 
 
 
 
 
pag. 16 
18. Conflicts of interest  
 
 
 
 
pag. 16 
19. Additional information  
 
 
 
 
pag. 16 
20. Bibliography 
 
 
 
 
 
pag. 17 
21. Appendix   
 
 
 
 
 
pag. 20 
21.1 Scores used for evaluation  
 
 
pag. 20 
 
 
 
 
 
 
 

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1. SYNOPSIS 
The elderly patient demented in an acute geriatric department: pilot study, monocentric, 
randomized on the use of aromatherapy as a complementary treatment tool to 
psychopharmacology in psychological disorders and behavior (BPSD).  
 
Rationale 
Behavioral and psycological symptoms of dementia (BPSD) are a big issue for families, 
paramedics, physician and the patient itself (1,2,3,4). 
 
In absence of universally recognized guidelines, the standard of treatment of these disorders 
involves the use of psychotropic drugs (typical/atypical neuroleptics, antidepressants, 
benzodiazepines) that are often found to have a reduce efficacy and induce a number of side 
effects such as sedation, impaired motor neurons slowdown, cardiac electrical alterations and 
extrapyramidal syndrome (5,6,7,8,9). In consideration of this, it is important to check for treating 
alternative ways, which can reduce psychological and behavioural disorders and at the same time 
can reduce the use of psychotropic drugs. 
Concerning the aromatherapy [10], the therapeutic use of natural essential oils, there are 
decades of clinical experience, especially in France, accompanied by increasing scientific evidence 
with significant increase in publications regarding its use of psychological disorders and dementia-
related behavior context (11,12,13,14). 
Based on the available scientific publications, it has been therefore decided to use two essential 
oils (Citrus sinensis, Lavandula angustifolia) in environmental diffusion within the Geriatric 
Department of the Clinic Luganese Moncucco. 
 
 
Objectives 
Primary objectives: through the execution of the Neuropsychiatric Inventory – Nursing Home 
Version (NPI-NH), the  neuropsychiatric and psychopathological symptoms of dementia patients 
will be evaluated in order to assess how the use of aromatherapy can improve the management 
of BPSD, reducing, where there is clinical indication, psychotropic therapy and secondary side 
effects. The score is considered positive if the presence of BPSD is greater than or equal to 1 (15, 
16,17); the improvement of the score is represented from decrease of the NPI-NH respect to the 
initial assessment (19, 20).Performing neuropsychological tests is not an additional attention to 
enrolled patients, but it is part of clinical practice (18). 
 
Secondary objectives: to validate the hypothesis that through the use of aromatherapy will 
improved the management of Behavioral and psycological symptoms of dementia (BPSD) in the 
dementia patient, with a concomitant reduction of the clinical staff stress who take care of 
patients (physician, nurses, care assistants), determined by the results reported by the 
Neuropsychiatric Inventory – Nursing Home Version (NPI-NH), In the specific section concerning 
 

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the distress measurement; improvement of the score is represented from decrease of the NPI-
NH respect to the initial assessment (19, 20). 
 
Project duration: 2 months of enrollment. 
 
Number of patients: 32, 16 patients for the control group and 16 patients for the group" 
aromatherapy". 
 
 
 
Inclusion criteria: 
- patients age  ≥ 70 years; 
- patients admitted to the acute geriatrics ward; 
- patients with known diagnosis of dementia associated with BPSD or diagnosis performed 
during hospitalization. 
 
Exclusion criteria: 
- patients with alcohol-based dementia; 
- patients with Mild Cognitive Impairment (MCI) – paragraph 4; 
- patients with language barriers; 
- patients already being treated with aromatherapy. 
 
Protocol design: prospective data collection of psychological disorders and behaviour in patients 
with diagnosis of dementia with associated behavioral and psycological symptoms of dementia 
(BPSD)- diagnosis already performed using neuropsychological tests (below), according Evidence 
Based Medicine,  and/or patients who BPSD diagnosis performed during the hospital stay in the 
Geriatric Competence Centre, Clinica Luganese Moncucco. 
The enrollment will be performed in May and June 2018. 
Enrolled patients will be treated with psychotropic drugs vs psychotropic drugs with 
aromatherapy in environmental diffusion. It is expected to use neuropsychological specific tests 
to assess dementia, motor and functional status patient status (CAM - Confusion Assessment 
Method -, CDR - Clinical Dementia Rating -, MMSE - Mini Mental State Examination -, FAB - Frontal 
Assessment Battery -, Tinetti Scale, BADL - Basic Activities of Daily Living -, IADL - Instrumental 
Activities of Daily Living -, NPI-NH – Neuropsychiatric Inventory – Nursing Home Version)). 
Patients enrolled in the project will not undergo to additional tests; the performed test are 
required in the standard clinical practice [18]. 
 
 

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GROUP A: 16 patients, following the inclusion criteria, will be enroll and they will be treated with 
psychotropic drugs. 
GROUP B: 16 patients, following the inclusion criteria, will be enroll and they will be treated with 
psychotropic drugs and, in a complementary way, with aromatherapy in environmental diffusion. 
 
 
 
 
  
 
 
 
 
 

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2. FLOW CHART   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Patients hospitalized in the acute 
geriatric dept from May to June 2018 
If NPI-NH >/= 1 
If NPI = 0 
Randomization in Group A or B 
Inclusion criteria: 
- patients ≥ 70 years; 
- patients admitted to the Acute Geriatric 
Ward; 
- patients with BPSD; 
 
Exclusion criteria: 
- patients with alcohol-based dementia; 
- patients with Mild Cognitive Impairment 
(MCI); 
- patients with language barriers; 
- patients already treated with aromatherapy. 
Non-acceptance 
Acceptance 
Signature of Informed Consent Form 
Patients enrollment (T0) 
Observation for 48 hrs an data collection: 
- age; 
- male or female; 
- CAM (Confusion Assessment Method); 
- CDR (Clinical Dementia Rating Score) 
- MMSE (Mini Mental State Examination); 
- FAB (Frontal Assessment Battery); 
- Tinetti's scale; 
- BADL (Basic Activities of Daily Living); 
- IADL (Instrumental Activities of Daily Living); 
- number/types of neuroleptics; 
- number/types of antidepressants; 
- number/types of benzodiazepines. 
NPI-NH rating: 
- NPI physician; 
- NPI nurse; 
- NPI care assistant. 

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Patient Enlistment (T1) 
Drop-out from the study 
GROUP A – GROUP B (start aromatherapy in 
environmental diffusion) according to the randomization 
group 
T2 (T1-3 days) 
NPI-NH rating: 
- NPI physician; 
- NPI nurse; 
- NPI care assistant. 
T3 (T1-6 days) 
 
1. NPI-NH assessment: 
- NPI physician; 
- NPI nurse; 
- NPI care assistant; 
 
2. Evaluation of PVs (vital parameters): 
- PAS (systemic blood pressure); 
- PAM (average blood pressure); 
- FC (heart rate); 
 
3. Evaluation of the drug reserves used: 
- number of neuroleptics 
- number of antidepressants 
- number of benzodiazepines 
T4 (T1-12 days) 
 
1. NPI-NH assessment: 
- NPI physician; 
- NPI nurse; 
- NPI care assistant; 
 
2. Evaluation of PVs (vital parameters): 
- PAS (systemic blood pressure); 
- PAM (average blood pressure); 
- FC (heart rate); 
 
3. Definition of the home therapeutic 
drugs scheme 

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3. STUDY CHARACTERISTIC 
Monocentric, randomized, pilot study which consists in the prospective data collection related to 
psychological disorders and behavior in the patient with dementia using neuropsychological tests in 
order to define the possible effectiveness of two essential oils (Citrus sinensis, Lavandula 
angustifolia) in the disorders control of psychological sphere and behavior of patients with 
degenerative or mixed type of dementia, admitted in the Geriatric Department of Clinica Luganese 
Moncucco in May and June 2018. 
 
In the proposal for therapeutic process of dementia patients in this project there is no disaccording 
with Evidence Based Medicine. 
Patients enrolled in the project will not undergo additional tests; the performed tests will follow the 
standard procedures of clinical practice [18]. 
 
 
4. PROTOCOL RATIONALE 
Behavioral and psycological symptoms of dementia (BPSD) are a major problem for families, 
physicians and the patient itself [1,2,3,4].   
Performing neuropsychological tests is not an additional source of distress for enlisted patients, 
but is part of clinical practice [18]. 
The standard treatment of these disorders involves the use of psychotropic drugs (typical/atypical 
neuroleptics, antidepressants, benzodiazepines) which are often ineffective and have a number of 
side effects such as sedation, reduction in cognitive performance, cardiac electrical alterations and 
extrapyramidal syndrome [5,6,7,8,9]. 
Within the scientific community, it is therefore mandatory to identify alternative ways of managing 
BPSDs, which can have a beneficial effect on patient life and, at the same time, a reduction in the 
used of psychotropic drugs. 
The therapeutic use of natural essential oils has decades of clinical experience, especially in France, 
accompanied by an increase numbers of publications in their use in BPSD [11,12,13,14]. 
The knowledge of alternative treatments of BPSD (such as aromatherapy) are the basis of our study 
project, which involves the introduction of essential oils in the BPSD management, while 
maintaining conventional psychotropic therapy (typical/atypical neuroleptics, antidepressants, 
benzodiazepines) in a prefixed form of ProReNata (PRN) (paragraph 5). 
The identified oils (Citrus sinensis, Lavender angustifolia) were selected on the degree of purity 
defined by the mass spectrophotometry available by the supplier.999 
The choice of adjuvant therapy with essential oils could allow, in accordance with the 3rd principle 
of Medical Ethics to administer natural treatment to patients with distress with BPSD reducing, if  
possible, use of psychotropic drugs and their major side effects. 
The use of essential oils in treatment of BPSD can also have a positive impact on patient economic 
management due to limited costs, allowing a distribution of treatments according to IV Principle of 
Ethics Medical: principle of justice. 

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Mild Cognitive Impairment (MCI) patients were excluded from the protocol as a form of pre-
dementia.[21].  
MCI is a neurological syndrome characterized by a cognitive impairment greater than that 
statistically expected based on age and education level, but who are still able to carry out their daily 
activities (BADL and IADL tests). The Mild Cognitive Impairment is considered a form of pre-
dementia, situated in a transition point between normal aging and dementia. 
 
5. STUDY POPULATION 
The population that will be evaluated within the project is constitute by patients with diagnosed 
dementia with BPSD (diagnosis carried out using, according to Evidence Based Medicine, the 
neuropsychological tests below) and/or by patients who the diagnosis of dementia with BPSD will 
be performed at the Geriatric Competence Centre of the Clinica Luganese Moncucco. 
The enrollment will be performed in May and June 2018. 
All patients mentioned above, within 48 hours after the admission at the Geriatric Department or 
the manifestation of BPSD, will be assessed to neuropsychological and functional tests (CAM - 
Confusion Assessment Method -, CDR - Clinical Dementia Rating Score -, MMSE - Mini Mental State 
Examination -, FAB - Frontal Assessment Battery -, scala di Tinetti, BADL - Basic Activities of Daily 
Living -, IADL - Instrumental Activities of Daily Living -), as required by Good Clinical Practice[18]. 
Subsequently, patients who can be enrolled in the study will be randomized into two groups, 
described below. 
Here is the study population on which we will focus: 
GROUP A – controls -: will be enrolled 16 patients eligible for criteria of inclusion, treated with 
psychotropic drugs. 
GROUP B – aromatherapy –: will be enrolled 16 patients eligible for criteria of inclusion, treated 
with psychotropic drugs and aromatherapy in air-diffusion. 
Based on the randomization, patients will be divided into group A – controls – and group B – 
aromatherapy in air diffusion. 
 
Neuropsychiatric Inventory (NPI) is a validated and useful tool for characterizing and assessing the 
BPSD frequency and seriousness.  
A Resident Physician will perform the NPI in our study protocol. 
The physician, by interview with patient's nurse, in absence of patient himself, will fill out the NPI-
NH. 
 

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The above mentioned physician, formerly operating in the Geriatric Department – who knows the 
geriatric assessments - and currently active in the Rheumatology Department, will therefore respect 
the blind study procedure. 
The geriatric nurse was chosen for the close relationship of care that is created with the patient; 
during the test, BPSD frequency and seriousness will be evaluated. 
The  psychological distress induced by BPSD patients, will be evaluated on the three figures who 
have in charge the patient, which are nurses, care assistants and the resident physicians. 
The psychological distress assessment is part of the NPI-NH test with a scale of severity from 0 to 5. 
  
Nurses will be undergo to NPI – NH test within 48 hours after patient admission or at first 
appearance of BPSD (T1), T2 (T1-3 days) 3 days after enrollment, at T3 (T1-6 days) 6 days after 
enrollment, at T4 (T1-12 days) at 14th day. According to the same timing, NPI-NH will also be 
performed to the resident physicians, the nurses and the care assistants to assess the psychological 
distress. The NPI-NH test will be performed following the Good Clinical Practice. 
The tests results performed to the two groups of patients will be considered in order to assess a 
possible reduction in BPSD. As the project is a pilot study, a descriptive analysis will be performed. 
Here the schemes defined for treatment with aromatherapy and psychotropic drugs, according to 
scientific publications in the first case and scientific publications and Evidence Based Medicine in 
the second: 
 
Aromatherapy 
Route of administration: air diffusion with ultrasonic diffuser in a single room and for about an hour. 
 
Doses: 
- Citrus sinensis: 6 drops at 8, 12 and 18 in nebulization 
and 
- Lavender angustifolia: 6 drops 8 p.m. in nebulization 
 
PRN PSYCOPHARMACOTHERAPY 
Drug: 
- in case of psychomotor agitation: 
 
Haloperidol 1 mg PO 10 times in 24 hours 
1 mg SC/IM 5 times in 24 hours 
Reperidone 0.5mg - 2mg PO in 24 hours 
Olanzapine 2.5 mg – 5 mg PO in 24 hours 
 
 
Clozapine 6.25 mg – 25 mg PO in 24 hours 

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Quetiapine 12.5mg - 150mg PO in 24 hours 
- in case of sleep disturbance: 
 
Valerian 1 tb - 2 tbs PO in 24 hours 
 
Melatonin 1 tb - 2 tbs PO in 24 hours 
 
Lorazepam 0.5 mg - 3mg PO in 24 hours 
 
Oxazepam 7.5mg - 45mg PO in 24 hours 
 
Clomethiazole 1 tb -3 tbs PO in 24 hours 
- in case of anxiety/depression: 
 
Trazodone 25 mg – 150 mg PO in 24 hours 
 
Escitalopram 10 mg – 20 mg PO in 24 hours 
     Mirtazapine 15 mg – 45 mg PO in 24 hours 
     Citalopram 10 mg – 20 mg PO in 24 hours 
     Paroxetine 20 mg – 50 mg PO in 24 hours 
 
The control group is treated with psychopharmacological therapy, defined by the PI, according to 
the Evidence Based Medicine criteria. 
Patient can withdraw the ICF at any time. 
The investigators could decide to withdraw a patient for safety and health. 
The withdrawn patients will not be evaluated unless they have been treated for 8 days, useful to 
evaluate the aromatherapy efficacy.  
In bibliography reported that essential oils in air diffusion are effective in 3 days. Additional 5 days 
of treatment allow to stabilize patient's condition and collect, through the NPI-NH test, changing in 
BPSD data. 
Withdrawn patients will be followed according to the standards of care provided by the Clinica 
Luganese Moncucco. 
 
6. PROJECT OBJECTIVES 
The goal of this project is to evaluate the effectiveness of aromatherapy in air diffusion in addition 
to psychotropic drugs in order to evaluate a possible reduction in BPSD. 
The project's hypothesis is that GROUP B patients show an improvement in their BPSD. The 
performed neuropsychological tests will provide the answer to the project hypotesis. 
Primary objectives: validate the hypothesis that the use of aromatherapy in air diffusion can 
improve the BPSD management, allowing a reduce in psychotropic therapy prescribed and its 
secondary side effects. The patient’s nurses will be tested with NPI-NH, that will characterize 

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frequency and seriousness of BPSD [15,16, 17]. A score greater or equal to 1 is considered positive 
for presence of BPSD. 
Secondary objectives: validate the hypothesis that the use of aromatherapy will improve the 
management of BPSD patients, with a simultaneously reduction of physicians, nurses and care 
assistants stress. The last aspect will be evaluated with a specific part of NPI-NH test. The decrease 
of the initial score represented an improvement [19.20]. The  NPI-NH test will be performed 
according to the time points defined in paragraph 7.1.1 
The obtained results could be interesting to the future implementation of the use of essential oils 
in air diffusion in acute geriatric departments and in all facilities with BPSD patients.  
 
7. RANDOMIZATION 
Enrolled patients with BPSD will be randomized according to the following randomization scheme 
(AABB, ABAB, BBAA, BABA, ABBA, BAAB). 
A repetition of the first 4blocks will be performed, for a total of 32 patients, 16 each group, 
according to the following scheme: 
  
AABB, ABAB, BBAA, BABA 
AABB, ABAB, BBAA, BABA 
 
8. PROJECT DESIGN 
The project will be managed in the acute geriatric department of the Clinica Luganese Moncucco. 
Enrolment and treatment scheme is present in the flow chart (chapter 2). 
After randomization patients will be enrolled in the two groups GROUP A, control group, and GROUP 
B, treatment group. 
The enrollment will be performed in 2 months. 
GROUP A: 16 patients, following the inclusion criteria, will be enroll and they will be treated with 
psychotropic drugs. 
GROUP B: 16 patients, following the inclusion criteria, will be enroll and they will be treated with 
psychotropic drugs and, in a complementary way, with aromatherapy in environmental diffusion. 
 
The project hypothesis will be validated using the following neuropsychological and functional tests: 
− CAM (Confusion Assessment Method); 
− CDR (Clinical Dementia Rating Score) 
− MMSE (Mini Mental State Examination); 
− FAB (Frontal Assessment Battery); 

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− Tinetti's scale; 
− BADL (Basic Activities of Daily Living); 
− IADL (Instrumental Activities of Daily Living); 
− NPI-NH (Neuropsychiatric Inventory – Nursing Home Version);  
 
Neuropsychological tests are part of clinical practice [18]. 
 
Scientific reports show that essential oils in air diffusion are effective in 3 days. A final timepoints of 
14 days represent the mean hospital stay: 
2 days for the collection of behavioral data; 
6 days to observe the possible effectiveness of aromatherapy in air diffusion; 
6 days to adapt the therapy with oils and psychotropic drugs and stabilize patient's condition for a 
possible discharge. 
 
Enrolled patients and nurses will be tested according to the following times: 
8.1.1 Observation for 48 hours with data collection and execution of the NPI-NH (T1): in the 48 
hours after patient admission at the Geriatric Department or at the diagnosis of dementia, the 
information collection will be performed: sensitive data (age, gender), dementia condition  (CAM, 
CDR, MMSE, FAB), functional status (IADL, BADL, Tinetti scale) and the used number of psychotropic 
drugs. As a result of this evaluation, patient will be assessed for the presence of BPSD using the NPI-
NH assessment scale, nurses will be undergo to NPI – NH test within 48 hours after patient 
admission. In case of a score greater than or equal to 1, patient will be followed within the study 
project, otherwise it will follow the standard process.  
8.1.2 Assessment of NPI-NH at T2 (T1-3 days): 3 days after enrollment, patient will be re-evaluated 
with NPI-NH to assess BPSD progress. In addition, the distress level of on the three health caregivers 
is also measured with the NPI-NH test. 
8.1.3 Assessment of NPI-NH at T3, assessment of vital parameters and use of drug reserves (T1-6 
days): 6 days after enrollment, NPI-NH will be re-executed, with associated assessment of patient's 
vital signs (PAS, PAM, FC) and the use of psychotropic drug reserves. 
8.1.4 Final T4 assessment (T1-12 days): NPI-NH scale will be performed in association with vital 
signs. 
The physician in charge of dispensing the NPI-NH questionnaires to nurses to collect BPSD patients 
status, will also submit the questionnaires to  the referring physician, nurse and care assistants with 
the aim to assess the level of stress in the clinical staff  (see "Distress" column in NPI-NH 
questionnaire in the appendix).  
 
 

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9. ELEGIBILITY CRITERIA 
Inclusion criteria: 
- patients ≥ 70 years; 
- patients admitted to the Acute Geriatric Ward; 
- patients with known diagnosis of dementia associated with BPSD or diagnosis performed during 
the hospitalization. 
 
Exclusion criteria: 
- patients with alcohol-based dementia; 
- patients with Mild Cognitive Impairment (MCI) – paragraph 4 -; 
- patients with language barriers; 
- patients already being treated with aromatherapy. 
 
Patients admitted to the Geriatric Competence Centre of the Clinica Luganese Moncucco who do 
not respect inclusion criteria at the time of admission but develop them in the course of stay in the 
Clinic (for example: patient without psychological disorders and behavior at the entrance that 
manifest BPSD during hospitalization) could be enrolled.  
 
10. CODIFY AND REGISTRATION PROCEDURES 
A unique and increasing patient number (UPN) will be assigned to each patient. The clinical research 
unit of Clinica Luganese Moncucco will keep the dataset containing the correspondence between 
the UPN and the patient's personal and clinical data. All the analyzed data, available for scientific 
discussions or publishing, will be encoded. 
 
11. PROJECT DURATION 
Patients enrolment will be performed during May and June 2018. 
 
 
12. RISKS AND BENEFITS 
This project involves the use of essential oils, which are natural and with no collateral risks; the only 
risks the patient might present are hypersensitivity to essential oil [22]. 
If aromatherapy results efficacious in the management of BPSD, patients benefit would result in a 
reduction of the use of psychotropic therapy with a consecutive reduction in the side effects. 
At the same time as the effectiveness of aromatherapy, possible benefits will also be available for 
caregivers (doctors, nurses, patient care assistant, family members). 

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13. STATISTICAL CONSIDERATIONS 
This is a pilot study which required the enrollment of 32 patients. For this reason, the statistical 
considerations will be purely descriptive. 
Patients will be enrolled, according to the described randomization, in GROUP A, control group in 
which patients will be treated exclusively with traditional psychotropics drugs, or in group B, in 
which they will be treated with aromatherapy integrated with psychotropics drugs. 
 
14.ETHICS CONSIDERATIONS 
This protocol has been designed and written in accordance with the Helsinki Agreement, the 
International Good Clinical Practice ICH Guidelines and the arrangements of the European and Swiss  
regulatory authorities [23, 24, 25]. 
In consideration of the presence of potentially vulnerable subjects, in order to ensure the inalienable 
principle of patient autonomy (I principle of Medical Ethics), informed consent will be explained and 
requested to a relative/legal representative of the patient who has lost the ability to discern. 
 
15. DATA PUBLISHING POLICY 
The ownership of the data is of Clinica Luganese Moncucco. The results are also expected to be 
published in the event of negative results and the authors of the scientific work will be chosen 
according to their contribution. 
 
16. INSURANCE COVERAGE 
No specific insurance coverage is required. 
 
17. FUNDING 
The funding for this pilot project comes from the aromatherapy fund of the Geriatric Competence 
Centre of Clinica Luganese Moncucco.This fund is funded by private donations. No companies 
participated in the financing. 
 
18. CONFLICTS OF INTEREST 
The authors and collaborators of the study declare that they do not present any conflict of interest. 
 
19. ADDITIONAL INFORMATION 
As agreed with the Cantonal Ethics Committee, in order not to harm the sensitivity of patients and 
relatives involved in the study, the title of the protocol was changed only in informed consents, 
replacing the term "demented" with "with dementia." This measure has also not been applied to 
the protocol as it is a document that is not provided to relatives or involved patients, but is tool for 
the staff participating an the study.  
 
 
 

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20. BIBLIOGRAPHY 
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8. FDA Public Health Advisory. Deaths with antipsychotics in elderly patients with behavioral 
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21.APPENDIX   
 
 
 
21.1 Scores used for evaluation 
21.1.1 Confusion Assessment Method (CAM)  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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21.1.2 Mini Mental State Evaluation (MMSE) 
 
 
 
 
 

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21.1.3 Frontal Assessment Battery (FAB) 
 
 

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21.1.4 Tinetti 
 
 
 
 

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21.1.5 Addiction index in everyday activities (BADL) 
 
 
 
 
 
 
 
 
 
 
 
 

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21.1.6 Addiction index in the instrumental activities of daily life (IADL) 
 
 
 
 
 
 
 

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21.1.7 Neuropsychiatric Inventory NPI-NH 
  
 
 
 
 
 
 

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21.1.8 Clinical Dementia Rating (CDR)