Alzheimer's Disease (AD) and Related DisordersMusicAlzheimerNCT02833870
Non-pharmacological Care of Alzheimer's Disease: Benefice of Musical Interventions
A study testing Musical intervention and Non-musical (cooking) intervention in people with Alzheimer's Disease (AD) and Related Disorders, run by CHU de Reims at 1 site in France.
Trial summary
Cares of Alzheimer's disease (AD) and related disorders are presenting a real public health challenge. Because of the limited effectiveness of pharmacological treatments, there is a growing interest in care approach based on nonpharmacological treatments, such as musical interventions. Read more about this study
- Who is it for?
- Ages 60 to 99 years
- Conditions the study is for
- Alzheimer's Disease (AD) and Related Disorders
- What is being tested?
- Musical intervention and Non-musical (cooking) intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to Jun 2015
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older People and francophones living in institutions
- Presenting a cortical degenerative disease
- Male or female
- Age 60 to 99 years
- French Mother tongue
- People enjoying a social security scheme
- Patient Participation Agreement and of the person of trust or his legal representative.
Who cannot join
- Patients without cortical degenerative disease
- Patients with uncorrected profound hearing loss
- Not affiliated with a social security scheme Patients .
- Patients refusing to participate in the study or with the agreement of the person of trust or his legal representative was not obtained
- Patient protected by law
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-drug Taken Charge of Alzheimer's Disease: Profit Musical Activities
Cares of Alzheimer's disease (AD) and related disorders are presenting a real public health challenge. Because of the limited effectiveness of pharmacological treatments, there is a growing interest in care approach based on nonpharmacological treatments, such as musical interventions. Several lines of evidence suggest that musical interventions could improve behaviour, emotion and even cognition in patients with AD. However, very few studies respond to the methodological constraints required for clinical controlled trials carried out in well selected groups of patients. The efficiency of such care approaches is not scientifically proved yet and the impact of musical interventions has rarely been compared to another pleasant intervention, leaving open the question about the specific benefits of music in patients with dementia. The main goal of this research project is to demonstrate short and longer-term efficiencies and the specificity of musical interventions in dementia by investigating their effects not only in patients but also in familial and professional caregivers.
Read the detailed description
To generalize previous results showing that non pharmacological therapy based on musical interventions improved emotional state in patients with severe AD to a larger sample of patients and to demonstrate the possible effects on caregivers, the investigators carried out a randomized controlled study with three parallel arms in institutionalized patients with severe AD (study 1) and in patients with mild AD leaving at home (study 2) to compare the impact of two interventions, a musical and a non-musical (cooking), to a control group (without any intervention). The control activity (cooking) was selected because it shares different features with music. Both interventions provide pleasure, are multisensory and may trigger old memories. In addition, both activities can be carried out in groups. A protocol consisting of various selected tests and questionnaires was used to assess the emotional, behavioural and cognitive abilities. Professional and familial caregivers also filled out other questionnaires to assess potential indirect benefits from both interventions on caregiver burnout and familial caregiver burden. Six assessments were proposed, two before, two during and two after interventions (follow-up) to respectively evaluate short and longer-term benefits of both interventions whereas test -retest effects will be controlled. Psychologists in charge to these assessments will be blind in regard to patients' group (musical versus cooking sessions, no intervention). Data were analyzed with methods from social psychology to decode non-verbal behaviours (e.g. visual contact) and emotional indexes in facial and verbal expressions and with methods from classical neuropsychology and from health domain. The collaboration between the two university teams from Lille and the special care unit (Pole EHPAD-USLD in Reims Hospital) provided complementary skills to this project that ensured its feasibility.
- Being tested
- Musical intervention, Non-musical (cooking) intervention, Control with no intervention
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musical interventionBehavioural
Non-musical (cooking) interventionBehavioural
Control with no interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Musical intervention | Experimental | Not described Receives: Behavioral: Musical intervention |
| Non-musical (cooking) intervention | Experimental | Not described Receives: Behavioral: Non-musical (cooking) intervention |
| Control with no intervention | Active comparator | Not described Receives: Behavioral: Control with no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall score in the Neuropsychiatric Inventory
Measured: up to 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startSep 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease (AD) and Related DisordersStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833870
- Sponsor's protocol ID
- PO13125 252Au12
- Acronym
- MusicAlzheimer
- Status last verified
- Dec 2016
- First submitted
- 8 Jul 2016
- Last updated
- 2 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-drug Taken Charge of Alzheimer's Disease: Profit Musical Activities
- ClinicalTrials.gov ID
- NCT02833870
- Acronym / sponsor ID
- MusicAlzheimer / PO13125 252Au12
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 14 Jul 2016 (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.
Cares of Alzheimer's disease (AD) and related disorders are presenting a real public health challenge. Because of the limited effectiveness of pharmacological treatments, there is a growing interest in care approach based on nonpharmacological treatments, such as musical interventions. Several lines of evidence suggest that musical interventions could improve behaviour, emotion and even cognition in patients with AD. However, very few studies respond to the methodological constraints required for clinical controlled trials carried out in well selected groups of patients. The efficiency of such care approaches is not scientifically proved yet and the impact of musical interventions has rarely been compared to another pleasant intervention, leaving open the question about the specific benefits of music in patients with dementia. The main goal of this research project is to demonstrate short and longer-term efficiencies and the specificity of musical interventions in dementia by investigating their effects not only in patients but also in familial and professional caregivers.
Detailed description
To generalize previous results showing that non pharmacological therapy based on musical interventions improved emotional state in patients with severe AD to a larger sample of patients and to demonstrate the possible effects on caregivers, the investigators carried out a randomized controlled study with three parallel arms in institutionalized patients with severe AD (study 1) and in patients with mild AD leaving at home (study 2) to compare the impact of two interventions, a musical and a non-musical (cooking), to a control group (without any intervention). The control activity (cooking) was selected because it shares different features with music. Both interventions provide pleasure, are multisensory and may trigger old memories. In addition, both activities can be carried out in groups. A protocol consisting of various selected tests and questionnaires was used to assess the emotional, behavioural and cognitive abilities. Professional and familial caregivers also filled out other questionnaires to assess potential indirect benefits from both interventions on caregiver burnout and familial caregiver burden. Six assessments were proposed, two before, two during and two after interventions (follow-up) to respectively evaluate short and longer-term benefits of both interventions whereas test -retest effects will be controlled. Psychologists in charge to these assessments will be blind in regard to patients' group (musical versus cooking sessions, no intervention). Data were analyzed with methods from social psychology to decode non-verbal behaviours (e.g. visual contact) and emotional indexes in facial and verbal expressions and with methods from classical neuropsychology and from health domain. The collaboration between the two university teams from Lille and the special care unit (Pole EHPAD-USLD in Reims Hospital) provided complementary skills to this project that ensured its feasibility.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Musical intervention | Experimental | Behavioral: Musical intervention |
| Non-musical (cooking) intervention | Experimental | Behavioral: Non-musical (cooking) intervention |
| Control with no intervention | Active comparator | Behavioral: Control with no intervention |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Older People and francophones living in institutions
- Presenting a cortical degenerative disease
- Male or female
- Age 60 to 99 years
- French Mother tongue
Key exclusion criteria (5 listed)
- Patients without cortical degenerative disease
- Patients with uncorrected profound hearing loss
- Not affiliated with a social security scheme Patients .
- Patients refusing to participate in the study or with the agreement of the person of trust or his legal representative was not obtained
- Patient protected by law
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 |
|---|---|---|
| Musical intervention | Behavioural | Musical intervention |
| Non-musical (cooking) intervention | Behavioural | Non-musical (cooking) intervention |
| Control with no intervention | Behavioural | Control with no intervention |
Primary outcome
Overall score in the Neuropsychiatric Inventory
Time frame: up to 11 weeks
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 2 Jan 2017.
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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?
A study testing Musical intervention and Non-musical (cooking) intervention in people with Alzheimer's Disease (AD) and Related Disorders, run by CHU de Reims 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 7 inclusion and 5 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 2 Jan 2017. 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?
Overall score in the Neuropsychiatric Inventory (time frame: up to 11 weeks). 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 2 Jan 2017.