Cognitive DeteriorationSaFEE2NCT02518243
Safe & Easy for Alzheimer's Disease and Related Pathologies
A study testing Patient's answer with non pharmacological therapeutic in people with Cognitive Deterioration, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
All over the world the increasing prevalence of chronic disorders and its impact on functional decline is challenging the sustainability of health care systems. Older individuals also frequently experience the reversible "frailty syndrome", which overlaps with chronic diseases, increasing incidence of disability. Read more about this study
- Who is it for?
- Ages 60 to 60 years
- Conditions the study is for
- Cognitive Deterioration
- What is being tested?
- Patient's answer with non pharmacological therapeutic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to 22 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects with a diagnosis of Alzheimer's disease according to NINCDS-ADRDA (McKhann, Drachman et al. 1984) or typical or atypical Alzheimer's disease (Dubois B. et al. 2007).
- Score at Mini Mental Test (MMSE) ≥16.
- Subjects residing in nursing homes.
- Subjects beneficiaries of a social security scheme.
- Signature of free and informed consent.
Who cannot join
- Failure to pass the neuropsychological tests because of a sensory or motor deficit.
- Sensory deficit (olfactory or visual) preventing the patient made perfectly meet the therapeutic solutions.
- Prescription of a new treatment psychotropic (hypnotic, anxiolytic, antidepressant, antipsychotic) in the week before the evaluation;
- Persons deprived of liberty (administrative or judicial).
Trial locations and contacts
1 site in 1 country.
About this study
All over the world the increasing prevalence of chronic disorders and its impact on functional decline is challenging the sustainability of health care systems. Older individuals also frequently experience the reversible "frailty syndrome", which overlaps with chronic diseases, increasing incidence of disability.
Building a global system aiming to take in charge all causes leading to loss of autonomy is a rather complicated task involving numerous Information and Communication technologies (ICT) solutions which are not always easy to use in everyday life.
Read more
The SafEE (Safe Easy Environment) project aim is to improve the safety, autonomy and quality of life of older people at risk.
The SafEE2 project develop non pharmacological therapeutic through diferent ICT (stimulation aromatherapy automatic fragrance ...) .
The goal of this study is to validate the acceptability, sensitivity and efficacy of the systems.
Read the detailed description
The non pharmacological therapeutic will be install at hospital room :
- aromatherapy,
- music therapy,
- cognitive training in multimedia application offering cognitive games.
- Conditions
- Cognitive Deterioration
- Being tested
- Patient's answer with non pharmacological therapeutic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient's answer with non pharmacological therapeuticOther
Installation at patient's home of :
- aromatherapy
- music therapy
- cognitive training in multimedia application offering cognitive games
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's Disease | Experimental | Not described Receives: Other: Patient's answer with non pharmacological therapeutic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance of the systems set up and use frequency evaluated using the Caregiver Questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startJun 2015
- Primary completion22 Mar 2017
- Study completion22 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeteriorationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renaud DAVID, MD, Study director, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518243
- Sponsor's protocol ID
- 14-PP-08
- Acronym
- SaFEE2
- Status last verified
- Nov 2023
- First submitted
- 7 Jul 2015
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe & Easy for Alzheimer's Disease and Related Pathologies
- ClinicalTrials.gov ID
- NCT02518243
- Acronym / sponsor ID
- SaFEE2 / 14-PP-08
- Conditions
- Cognitive Deterioration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- 22 Mar 2017 (actual)
- Study completion
- 22 Mar 2017 (actual)
- First posted
- 7 Aug 2015 (estimated)
- 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.
All over the world the increasing prevalence of chronic disorders and its impact on functional decline is challenging the sustainability of health care systems. Older individuals also frequently experience the reversible "frailty syndrome", which overlaps with chronic diseases, increasing incidence of disability.
Building a global system aiming to take in charge all causes leading to loss of autonomy is a rather complicated task involving numerous Information and Communication technologies (ICT) solutions which are not always easy to use in everyday life.
The SafEE (Safe Easy Environment) project aim is to improve the safety, autonomy and quality of life of older people at risk.
The SafEE2 project develop non pharmacological therapeutic through diferent ICT (stimulation aromatherapy automatic fragrance ...) .
The goal of this study is to validate the acceptability, sensitivity and efficacy of the systems.
Detailed description
The non pharmacological therapeutic will be install at hospital room :
- aromatherapy,
- music therapy,
- cognitive training in multimedia application offering cognitive games.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's Disease | Experimental | Other: Patient's answer with non pharmacological therapeutic |
Who may qualify
- Ages
- 60 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects with a diagnosis of Alzheimer's disease according to NINCDS-ADRDA (McKhann, Drachman et al. 1984) or typical or atypical Alzheimer's disease (Dubois B. et al. 2007).
- Score at Mini Mental Test (MMSE) ≥16.
- Subjects residing in nursing homes.
- Subjects beneficiaries of a social security scheme.
- Signature of free and informed consent.
Key exclusion criteria (4 listed)
- Failure to pass the neuropsychological tests because of a sensory or motor deficit.
- Sensory deficit (olfactory or visual) preventing the patient made perfectly meet the therapeutic solutions.
- Prescription of a new treatment psychotropic (hypnotic, anxiolytic, antidepressant, antipsychotic) in the week before the evaluation;
- Persons deprived of liberty (administrative or judicial).
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 |
|---|---|---|
| Patient's answer with non pharmacological therapeuticInstallation at patient's home of : * aromatherapy * music therapy * cognitive training in multimedia application offering cognitive games | Other | Alzheimer's Disease |
Primary outcome
Tolerance of the systems set up and use frequency evaluated using the Caregiver Questionnaire
Time frame: 3 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 14 Nov 2023.
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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.
Renaud DAVID, MD study director
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient's answer with non pharmacological therapeutic in people with Cognitive Deterioration, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 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 14 Nov 2023. 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 France. 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?
Tolerance of the systems set up and use frequency evaluated using the Caregiver Questionnaire (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2023.