Alzheimer's DiseaseNCT00190372
AIDMA: A Psycho-educational Program Designed to Support and Train Carers of Alzheimer's Disease (AD) Patients
A study testing Self-hypnotic relaxation in people with Alzheimer's Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of the project is to demonstrate that a psycho-educational programme designed to support and train carers of Alzheimer's disease (AD) patients induces a significantly higher benefit than anticholinesterase drug treatment alone or associated to memantine treatment. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Self-hypnotic relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2004to May 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients:
- AD outpatients
- Stable pharmacological treatment
- Mini-Mental State Examination (MMSE) [10 -28]
- Age [60-90]
- Informed consent
Show all 12Show fewer
- Caregivers:
- Reliability
- Motivation
- Psychological disorder related to patient's disease
- Need for information or help
- Informed consent
Who cannot join
- Patients:
- Other dementia
- Severe general disease
- No reliable caregiver
- Caregivers:
- Physical or mental disease incompatible with patient's management
Show all 9Show fewer
- Impossibility to participate in the educational program
- Absence of anxiety-depression
- Psychotherapy
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique-Hôpitaux de Paris
Paris, Île-de-France Region, 75010
About this study
Official title: Contribution of a Psycho-Educational Program of Help to Help in the Pharmacological Assumption of Responsibility of the Disease of Alzheimer
The aim of the project is to demonstrate that a psycho-educational programme designed to support and train carers of Alzheimer's disease (AD) patients induces a significantly higher benefit than anticholinesterase drug treatment alone or associated to memantine treatment. This training programme focuses on the explanation/description of behavioral, cognitive and functional disorders induced by the disease, as well as principles of cognitive and psycho-social stimulation of the patients in daily life.
Read the detailed description
Context: Research showing the benefit of a combined approach including specific antidementia drugs and psycho-educational programmes for caregivers in the caring of Alzheimer's disease patients is still lacking. We venture the hypothesis that combined treatment including a specific antidementia drug for the AD patient and a psycho-educational programme for the caregivers has a larger benefit for both the patient and the caregiver on psychological, behavioural, and cognitive parameters.
Main objective: to demonstrate that a psycho-educational programme designed to support and train carers of Alzheimer's disease (AD) patients induces a significantly higher benefit than anticholinesterase drug treatment alone or associated to memantine treatment.
Secondary objective: identify patterns of responders and non-responders (taking into account cognitive, psychological parameters).
Methodology: national multicentric, randomized trial, single blinded, with 2 parallel groups of 120 patients and 120 caregivers trained for a 3 month period with 3 assessments: before, just after and 3 months after the training period. Patients and caregivers are recruited (according to exclusion and inclusion criteria) and followed up in memory centers participating in the trial.
Evaluation criteria:
Primary criteria for the patient: DAD scale (Disability Assessment for Dementia).
Secondary evaluation criteria - for the patient: NPI and ADAS-Cog; for the caregiver: ZARIT scale, Questionnaire of feeling of competency, Montgomery and Asberg Depression Rating Scale (MADRS), Geriatric Depression Scale (GDS).
Statistical analysis by the department of biostatistics and medical computing of the Hospital Cochin will be performed.
- Conditions
- Alzheimer's Disease
- Being tested
- Controlled diet, Self-hypnotic relaxation
- Keywords
- Alzheimer's disease training programme, educational programme caregivers carers dementia treatment, Dementia Cognitive disorder
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled dietBehavioural
Controlled diet
Self-hypnotic relaxationBehavioural
Self-hypnotic relaxation
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Not described Receives: Behavioral: Controlled diet; Behavioral: Self-hypnotic relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
DAD scale (Disability Assessment for Dementia)
Measured: at 6 months
Secondary outcomes (6)
cardiovascular mortality
Measured: at 6 months
functional status
Measured: at 4 weeks
for the patient: NPI and ADAS-Cog
Measured: during the study
for the caregiver: ZARIT scale, questionnaire of feeling of competency, Montgomery and Asberg Depression Rating Scale (MADRS), Geriatric Depression Scale (GDS)
Measured: during the study
all cause mortality
Measured: at one year
score on a depression rating scale
Measured: at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Care provider
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Anne-Sophie Rigaud, Pr, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00190372
- Sponsor's protocol ID
- P030437
- Status last verified
- Mar 2007
- First submitted
- 14 Sep 2005
- Last updated
- 17 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wenisch E, Stoker A, Bourrellis C, Pasquet C, Gauthier E, Corcos E, Banchi MT, De Rotrou J, Rigaud AS. [A global intervention program for institutionalized demented patients]. Rev Neurol (Paris). 2005 Mar;161(3):290-8. doi: 10.1016/s0035-3787(05)85035-0. French.
PubMed 15800450
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of a Psycho-Educational Program of Help to Help in the Pharmacological Assumption of Responsibility of the Disease of Alzheimer
- ClinicalTrials.gov ID
- NCT00190372
- Acronym / sponsor ID
- P030437
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease training programme, educational programme caregivers carers dementia treatment, Dementia Cognitive disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 19 Sep 2005 (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 aim of the project is to demonstrate that a psycho-educational programme designed to support and train carers of Alzheimer's disease (AD) patients induces a significantly higher benefit than anticholinesterase drug treatment alone or associated to memantine treatment. This training programme focuses on the explanation/description of behavioral, cognitive and functional disorders induced by the disease, as well as principles of cognitive and psycho-social stimulation of the patients in daily life.
Detailed description
Context: Research showing the benefit of a combined approach including specific antidementia drugs and psycho-educational programmes for caregivers in the caring of Alzheimer's disease patients is still lacking. We venture the hypothesis that combined treatment including a specific antidementia drug for the AD patient and a psycho-educational programme for the caregivers has a larger benefit for both the patient and the caregiver on psychological, behavioural, and cognitive parameters.
Main objective: to demonstrate that a psycho-educational programme designed to support and train carers of Alzheimer's disease (AD) patients induces a significantly higher benefit than anticholinesterase drug treatment alone or associated to memantine treatment.
Secondary objective: identify patterns of responders and non-responders (taking into account cognitive, psychological parameters).
Methodology: national multicentric, randomized trial, single blinded, with 2 parallel groups of 120 patients and 120 caregivers trained for a 3 month period with 3 assessments: before, just after and 3 months after the training period. Patients and caregivers are recruited (according to exclusion and inclusion criteria) and followed up in memory centers participating in the trial.
Evaluation criteria:
Primary criteria for the patient: DAD scale (Disability Assessment for Dementia).
Secondary evaluation criteria - for the patient: NPI and ADAS-Cog; for the caregiver: ZARIT scale, Questionnaire of feeling of competency, Montgomery and Asberg Depression Rating Scale (MADRS), Geriatric Depression Scale (GDS).
Statistical analysis by the department of biostatistics and medical computing of the Hospital Cochin will be performed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Other | Behavioral: Controlled diet, Behavioral: Self-hypnotic relaxation |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- AD outpatients
- Stable pharmacological treatment
- Mini-Mental State Examination (MMSE) [10 -28]
- Age [60-90]
- Informed consent
Key exclusion criteria (9 listed)
- Other dementia
- Severe general disease
- No reliable caregiver
- Physical or mental disease incompatible with patient's management
- Impossibility to participate in the educational program
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 |
|---|---|---|
| Controlled dietControlled diet | Behavioural | A |
| Self-hypnotic relaxationSelf-hypnotic relaxation | Behavioural | A |
Primary outcome
DAD scale (Disability Assessment for Dementia)
Time frame: at 6 months
6 secondary outcomes
cardiovascular mortality
Time frame: at 6 months
functional status
Time frame: at 4 weeks
for the patient: NPI and ADAS-Cog
Time frame: during the study
for the caregiver: ZARIT scale, questionnaire of feeling of competency, Montgomery and Asberg Depression Rating Scale (MADRS), Geriatric Depression Scale (GDS)
Time frame: during the study
all cause mortality
Time frame: at one year
score on a depression rating scale
Time frame: at 6 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 17 Feb 2011.
- Background: PubMed 15800450Wenisch E, Stoker A, Bourrellis C, Pasquet C, Gauthier E, Corcos E, Banchi MT, De Rotrou J, Rigaud AS. [A global intervention program for institutionalized demented patients]. Rev Neurol (Paris). 2005 Mar;161(3):290-8. doi: 10.1016/s0035-3787(05)85035-0. French.
Related trials for Alzheimer's Disease
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease
Alzheimer's Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Assessing Treatment With High-phenolic EVOO Supplements for Neurovascular Activity
Mild Cognitive Impairment (MCI)
Active, not recruiting
Effectiveness of Strength-based Intervention for Elderly With Dementia Living in the Community
Dementia, Mild Cognitive Impairment
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.
Anne-Sophie Rigaud, Pr, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-hypnotic relaxation in people with Alzheimer's Disease, run by Assistance Publique - Hôpitaux de Paris 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 12 inclusion and 9 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 17 Feb 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. 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?
DAD scale (Disability Assessment for Dementia) (time frame: at 6 months). 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 NCT00190372, which also lists 1 linked publication.
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 17 Feb 2011.