Alzheimer's DiseaseNCT01143350
Non Pharmacological Treatment in Alzheimer's Disease and Associated Disorders
A study testing Bras A (EHPAD Training and stimulation) in people with Alzheimer's Disease, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The STIM-EHPAD study (for stimulation in nursing home) aims to evaluate the short and medium term effectiveness of staff education as a non-pharmacological intervention to manage apathy in older people with a diagnosis of dementia. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Bras A (EHPAD Training and stimulation)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2010to Mar 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients older than 65 years
- A diagnosis of dementia according to the ICD 10 criteria
- MMSE score ≤ 24
- Presenting the diagnostic criteria of apathy (cf page ??)
- An Apathy Inventory clinician total score >3 (with at least a score higher than 1 at one of the 3 dimensions; lack of initiative, lack of interest, emotional blunting)
Who cannot join
- Patients more than 65 years
- MMSE score > 24
Trial locations and contacts
1 site in 1 country.
About this study
The STIM-EHPAD study (for stimulation in nursing home) aims to evaluate the short and medium term effectiveness of staff education as a non-pharmacological intervention to manage apathy in older people with a diagnosis of dementia.
- Primary efficacy criteria: Apathy Inventory clinician score changes
- Secondary efficacy criteria: Apathy Inventory patient and caregiver version changes, Observation scale changes, frequency and severity of the other BPSD using the NPI, qualitative analysis of the nursing home staff behavioural changes
- Conditions
- Alzheimer's Disease
- Being tested
- Bras A (EHPAD Training and stimulation), EHPAD Control
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bras A (EHPAD Training and stimulation)Other
EHPAD of the group of Training / Stimulation will benefit:
- after a training in behaviours to be held or in methods of stimulation aiming at the reduction of disturbances of behaviour at type of apathy. This information will be transmitted in l 'ensemble of l 'équipe of l 'EHPAD by a training officer.
- of a structuring of the activities of animation offered to the inhabitants, This information will be regrouped in chips worked out like TNM - EHPAD.
EHPAD ControlOther
EHPAD of the reference group, will have their habitual functioning
| Study group | Role | What they receive |
|---|---|---|
| EHPAD Training and Stimulation | Experimental | EHPAD of the group of Training / Stimulation will benefit:
* after a training in behaviours to be held or in methods of stimulation aiming at the reduction of disturbances of behaviour at type of apathy. This information will be transmitted in l 'ensemble of l 'équipe of l 'EHPAD by a training officer.
* of a structuring of the activities of animation offered to the inhabitants, This information will be regrouped in chips worked out like TNM - EHPAD. Receives: Other: Bras A (EHPAD Training and stimulation) |
| 2- EHPAD control | Placebo comparator | EHPAD of the reference group, will have their habitual functioning Receives: Other: EHPAD Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of yet unknown enzymes involved in the processing of Ab, especially on those responsible for the exoproteasic truncation of Ab at its N-terminus.
Identification of yet unknown enzymes involved in the processing of Ab, especially on those responsible for the exoproteasic truncation of Ab at its N-terminus.
Measured: 1 year
Secondary outcomes (1)
Secondary efficacy criteria: Apathy Inventory patient and caregiver version changes, Observation scale changes, frequency and severity of the other BPSD using the NPI, qualitative analysis of the nursing home staff behavioural changes
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Investigators
- Philippe Ph ROBERT, PhD, Principal investigator, CHU de Nice - CM2R - Hôpital de Cimiez - 4 avenue reine victoria - 06 003 Nice cedex 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143350
- Sponsor's protocol ID
- 09-PP-09
- Status last verified
- Mar 2010
- First submitted
- 25 Feb 2010
- Last updated
- 1 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Pharmacological Treatment in Alzheimer's Disease and Associated Disorders
- ClinicalTrials.gov ID
- NCT01143350
- Acronym / sponsor ID
- 09-PP-09
- Conditions
- Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 14 Jun 2010 (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.
The STIM-EHPAD study (for stimulation in nursing home) aims to evaluate the short and medium term effectiveness of staff education as a non-pharmacological intervention to manage apathy in older people with a diagnosis of dementia.
- Primary efficacy criteria: Apathy Inventory clinician score changes
- Secondary efficacy criteria: Apathy Inventory patient and caregiver version changes, Observation scale changes, frequency and severity of the other BPSD using the NPI, qualitative analysis of the nursing home staff behavioural changes
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EHPAD Training and Stimulation | Experimental | Other: Bras A (EHPAD Training and stimulation)EHPAD of the group of Training / Stimulation will benefit: * after a training in behaviours to be held or in methods of stimulation aiming at the reduction of disturbances of behaviour at type of apathy. This information will be transmitted in l 'ensemble of l 'équipe of l 'EHPAD by a training officer. * of a structuring of the activities of animation offered to the inhabitants, This information will be regrouped in chips worked out like TNM - EHPAD. |
| 2- EHPAD control | Placebo comparator | Other: EHPAD ControlEHPAD of the reference group, will have their habitual functioning |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patients older than 65 years
- A diagnosis of dementia according to the ICD 10 criteria
- MMSE score ≤ 24
- Presenting the diagnostic criteria of apathy (cf page ??)
- An Apathy Inventory clinician total score >3 (with at least a score higher than 1 at one of the 3 dimensions; lack of initiative, lack of interest, emotional blunting)
Key exclusion criteria (2 listed)
- Patients more than 65 years
- MMSE score > 24
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 |
|---|---|---|
| Bras A (EHPAD Training and stimulation)EHPAD of the group of Training / Stimulation will benefit: * after a training in behaviours to be held or in methods of stimulation aiming at the reduction of disturbances of behaviour at type of apathy. This information will be transmitted in l 'ensemble of l 'équipe of l 'EHPAD by a training officer. * of a structuring of the activities of animation offered to the inhabitants, This information will be regrouped in chips worked out like TNM - EHPAD. | Other | EHPAD Training and Stimulation |
| EHPAD ControlEHPAD of the reference group, will have their habitual functioning | Other | 2- EHPAD control |
Primary outcome
Identification of yet unknown enzymes involved in the processing of Ab, especially on those responsible for the exoproteasic truncation of Ab at its N-terminus.
Time frame: 1 year
Identification of yet unknown enzymes involved in the processing of Ab, especially on those responsible for the exoproteasic truncation of Ab at its N-terminus.
1 secondary outcome
Secondary efficacy criteria: Apathy Inventory patient and caregiver version changes, Observation scale changes, frequency and severity of the other BPSD using the NPI, qualitative analysis of the nursing home staff behavioural changes
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2011.
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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.
Philippe Ph ROBERT, PhD principal investigator
CHU de Nice - CM2R - Hôpital de Cimiez - 4 avenue reine victoria - 06 003 Nice cedex 1
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bras A (EHPAD Training and stimulation) in people with Alzheimer's Disease, 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 2 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: stopped early, as of the sponsor's last update on 1 Jun 2011. 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. 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?
The study was stopped early. Results are not available in the source record.
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?
Identification of yet unknown enzymes involved in the processing of Ab, especially on those responsible for the exoproteasic truncation of Ab at its N-terminus. (time frame: 1 year). 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 1 Jun 2011.