Predemential Alzheimer PatientDem@CareNCT01661660
Ecological Assessment of Autonomy and Apathy
A study testing observationnal in people with Predemential Alzheimer Patient and Demential Alzheimer Patient, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Cognitive symptoms are the core feature of Alzheimer's disease. Besides these problems, behavioural and psychological symptoms (BPSD), and an impairment of activities of daily living (IADL) are frequently encountered and usually show an impact on autonomy maintenance, prognostic and care during the prodromal and early… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Predemential Alzheimer Patient, Demential Alzheimer Patient, Witness
- What is being tested?
- observationnal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2012to 1 Dec 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
None listed.
Who cannot join
- Failure to perform the protocol due to a mobility impairment;
- Prescription of a new psychotropic medication (hypnotic, anxiolytic, antidepressant, antipsychotic) in the week preceding the assessment;
- Patients implanted with a pacemaker;
- Patient Trust under curatorship or judicial protection;
- Detainees (administrative or judicial).
- Predementia / MCI Patients Inclusion criteria
Show all 29Show fewer
- Men or women ≥ 65 years.
- Subjects with a diagnosis of MCI according to the criteria of the National Institute on Ageing and Alzheimer's Association group (Albert MS, 2011, see Appendix B), or Alzheimer's disease stage prédementiel (B. Dubois, 2010; see Appendix C)
- Subjects with a score of 0 to items of "tremors" and "muscle stiffness" of the UPDRS III
- Subjects with no criteria for major depressive episode according to DSM IV-R;
- Subjects receiving a social security system;
- Signature of informed consent. Exclusion Criteria
- Failure to pass neuropsychological testing because of a sensory or motor deficit;
- Prescription of a new psychotropic medication (hypnotic, anxiolytic, antidepressant, antipsychotic) in the week preceding the assessment;
- Patients implanted with a pacemaker;
- Patient Trust under curatorship or judicial protection.
- dementia subjects Inclusion criteria
- Men and women older than 65 years
- Subjects with a diagnosis of Alzheimer's disease according to NINCDS-ADRDA (McKhann, Drachman et al. 1984) or Alzheimer's typical or atypical (B. Dubois et al. 2007)
- MMSE score ≥ 16
- Subjects with a score of 0 to items of "tremors" and "muscle stiffness" of the UPDRS III
- Subjects with no criteria for major depressive episode according to DSM IV-R;
- Subjects receiving drug treatment by acetylcholinesterase inhibitor or memantine in standard dose and stable for at least 3 months;
- Subjects receiving a social security system;
- Signature of informed consent.
- Failure to pass neuropsychological testing because of a sensory or motor deficit;
- Prescription of psychotropic medication (hypnotic, anxiolytic, antidepressant, antipsychotic) in the week preceding the assessment;
- Patients implanted with a pacemaker
- Patient Trust under curatorship or judicial protection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ecological Assessment of Autonomy and Apathy in Alzheimer Patients at Mild and Moderate Stages, as Welle as in Healthy Control Particpants
Cognitive symptoms are the core feature of Alzheimer's disease. Besides these problems, behavioural and psychological symptoms (BPSD), and an impairment of activities of daily living (IADL) are frequently encountered and usually show an impact on autonomy maintenance, prognostic and care during the prodromal and early stages of the disease.
Such symptoms are noticeable before the diagnosis of dementia and their occurrences as well as their intensity increase with the evolution of the disease.
Read more
Apathy, initially defined as a reduction of motivated behaviours, is the most frequently observed BPSD. Apathy is clinically defined by a significant reduction or complete loss of interest, initiative capacity and emotional blunting. Accordingly, apathy is characterized by diminished goal-directed cognitions and behaviours.
Behavioural and psychological assessment relies essentially on neuropsychiatric scales. These are used to gather precise data regarding patient's clinical state from interviews with the patient, the career or from clinical impressions during the consultation. From their apparent simplicity they have made their way into daily clinical practices, yet neuropsychiatric scales are reportedly biased by the assessors' subjectivity.
However, some tools whose allow simple, fast and objectively valid assessments are not widely used.
Hence, the use of ICT such as actigraphy (wearable device assessing locomotion activities), automatized audio-video recognition and signal analysis from events, may be of interest in addition to current assessment methods.
The aim of this study is to implement an objective assessment of goal directed activities and autonomy in an experimental design including predefined actions. The setting includes video cameras, microphones, actigraphic and Galvanic Skin Response sensors for recording and computer-based recognition of events using audio-video data, locomotion data and sinusal variability respectively as well as extracting biomarkers for supporting detection of dementia at early stages and supporting ongoing tracking of the dementia disease state. The following population will be included: patients with Mild Cognitive Impairment (n=50), patients with Alzheimer's disease (n=50) and control participants (n=50).
This work will provide further objective information for clinical practitioner in order to detect behavioral disturbances such as apathy.
- Being tested
- observationnal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationnalOther
Observation during a physical exercise
| Study group | Role | What they receive |
|---|---|---|
| Control subjects | Active comparator | Control subjects were people with memory complaints coming for a consultation and prevention. Receives: Other: observationnal |
| Predementia / MCI patients | Experimental | Subjects at predementia stage or MCI stage Receives: Other: observationnal |
| Dementia patient | Experimental | Subjects at demential stage Receives: Other: observationnal |
What is being measured
The primary outcome is the main question the study is designed to answer.
the evaluation score of autonomy
The primary outcome used to differentiate patients with Alzheimer's disease in pre-demented control subjects is the evaluation score of autonomy calculated from data collected during the execution of step semi directed
Measured: It will be evaluated at time = 0 for each patient
Secondary outcomes (1)
analyze differences between inter-group patients
The impact of behavioral problems in activities of daily living will be evaluated using the same criteria for evaluating the main objective analysis by an international group in a category between subjects diagnosed patients apathetic and not apathetic. Actigraphy data, recorded from the ecological assessment in experiment room until the end of the final medical examination, will quantify and qualify the motor activity of the subject at its presence on the premises of CMRR to compare these measures during the evaluation phases in experiment room, consulting and outside these two periods.
Measured: It will be evaluated at time = 0 for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study start25 Jun 2012
- Primary completion1 Dec 2015
- Study completion1 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Predemential Alzheimer PatientStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe ROBERT, PU-PH, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661660
- Sponsor's protocol ID
- 12-PP-01
- Acronym
- Dem@Care
- Status last verified
- Nov 2023
- First submitted
- 6 Jul 2012
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ecological Assessment of Autonomy and Apathy in Alzheimer Patients at Mild and Moderate Stages, as Welle as in Healthy Control Particpants
- ClinicalTrials.gov ID
- NCT01661660
- Acronym / sponsor ID
- Dem@Care / 12-PP-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 25 Jun 2012 (actual)
- Primary completion
- 1 Dec 2015 (actual)
- Study completion
- 1 Dec 2015 (actual)
- First posted
- 9 Aug 2012 (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.
Cognitive symptoms are the core feature of Alzheimer's disease. Besides these problems, behavioural and psychological symptoms (BPSD), and an impairment of activities of daily living (IADL) are frequently encountered and usually show an impact on autonomy maintenance, prognostic and care during the prodromal and early stages of the disease.
Such symptoms are noticeable before the diagnosis of dementia and their occurrences as well as their intensity increase with the evolution of the disease.
Apathy, initially defined as a reduction of motivated behaviours, is the most frequently observed BPSD. Apathy is clinically defined by a significant reduction or complete loss of interest, initiative capacity and emotional blunting. Accordingly, apathy is characterized by diminished goal-directed cognitions and behaviours.
Behavioural and psychological assessment relies essentially on neuropsychiatric scales. These are used to gather precise data regarding patient's clinical state from interviews with the patient, the career or from clinical impressions during the consultation. From their apparent simplicity they have made their way into daily clinical practices, yet neuropsychiatric scales are reportedly biased by the assessors' subjectivity.
However, some tools whose allow simple, fast and objectively valid assessments are not widely used.
Hence, the use of ICT such as actigraphy (wearable device assessing locomotion activities), automatized audio-video recognition and signal analysis from events, may be of interest in addition to current assessment methods.
The aim of this study is to implement an objective assessment of goal directed activities and autonomy in an experimental design including predefined actions. The setting includes video cameras, microphones, actigraphic and Galvanic Skin Response sensors for recording and computer-based recognition of events using audio-video data, locomotion data and sinusal variability respectively as well as extracting biomarkers for supporting detection of dementia at early stages and supporting ongoing tracking of the dementia disease state. The following population will be included: patients with Mild Cognitive Impairment (n=50), patients with Alzheimer's disease (n=50) and control participants (n=50).
This work will provide further objective information for clinical practitioner in order to detect behavioral disturbances such as apathy.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control subjects | Active comparator | Other: observationnalControl subjects were people with memory complaints coming for a consultation and prevention. |
| Predementia / MCI patients | Experimental | Other: observationnalSubjects at predementia stage or MCI stage |
| Dementia patient | Experimental | Other: observationnalSubjects at demential stage |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (29 listed)
- Failure to perform the protocol due to a mobility impairment;
- Prescription of a new psychotropic medication (hypnotic, anxiolytic, antidepressant, antipsychotic) in the week preceding the assessment;
- Patients implanted with a pacemaker;
- Patient Trust under curatorship or judicial protection;
- Detainees (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 |
|---|---|---|
| observationnalObservation during a physical exercise | Other | Control subjects, Dementia patient, Predementia / MCI patients |
Primary outcome
the evaluation score of autonomy
Time frame: It will be evaluated at time = 0 for each patient
The primary outcome used to differentiate patients with Alzheimer's disease in pre-demented control subjects is the evaluation score of autonomy calculated from data collected during the execution of step semi directed
1 secondary outcome
analyze differences between inter-group patients
Time frame: It will be evaluated at time = 0 for each patient
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 13 Nov 2023.
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 ROBERT, PU-PH principal investigator
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 observationnal in people with Predemential Alzheimer Patient and Demential Alzheimer Patient, 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 0 inclusion and 29 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 13 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?
the evaluation score of autonomy (time frame: It will be evaluated at time = 0 for each patient). 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 13 Nov 2023.