Alzheimer DiseaseNCT01384344
Ecological Assessment of Apathy in Alzheimer's Disease and in Control Subjects: Video Recognition and Actigraphy
A study testing observational in people with Alzheimer Disease, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Cognitive and memory disorders are characterized of Alzheimer disease. In addition, psychologic and behavioural symptoms, called speak neuropsychiatric symptoms, are frequents and play an important role in prognostic and intervention. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- observational
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2011to Jun 2012
- 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
- man or female, more 65 years ;
- no caregiver ;
- no motor handicap ;
- no global cognitive impairment with > 26 MMSE, neither argument in favour of following diagnosis : Alzheimer's disease, major depressive episode ;
- no apathy ;
- participant with french national health ;
Show all 17Show fewer
- signature of informed consent.
- man or female, more 65 years ;
- no motor handicap ;
- with diagnosis of Alzheimer's disease according to criteria of NINCDS-ADRDA ;
- apathy score > 3 in Neuropsychiatric Inventory ;
- with a MMSE score lower than 26/30 ;
- with cholinesterase inhibitor medication, standard and stable dose since 3 month ;
- no global cognitive impairment with > 26 MMSE, neither argument in favour of following diagnosis : Alzheimer's disease, major depressive episode ;
- no apathy ;
- participant with french national health ;
- signature of informed consent.
Who cannot join
- Impossibility of realization of the experimental protocol because of a driving handicap.
- Port(Bearing) of a pacemaker
- Under guardianship Patient or guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ecological Assessment of Apathy in Alzheimer's Disease and in Control Subjects: Interest on Video Recognition and Actigraphy
Cognitive and memory disorders are characterized of Alzheimer disease. In addition, psychologic and behavioural symptoms, called speak neuropsychiatric symptoms, are frequents and play an important role in prognostic and intervention. These symptoms are noticed before the diagnostic of dementia, their prevalence and their intensity increase with the evolution of disease. Apathy, which is characterized by a decrease of motivation, is the most frequent of this behaviour disrupt. Clinically, a decrease, or a totally, lack of interest, initiative and blunting emotional are noticed. Fundamentally, apathy is considered as a decrease of cognition and behaviour to "go in goal". Assessment of psychological and behavioural symptoms is realised principally with neuropsychiatric scales. These contribute to obtain particular informations about health of patient allowing by patient and caregiver discussions and impressions of clinician. These scales are simples but loss of subjectivity. An alternative of this method is the use of gerontechnology as actigraphy (system out-patient which records locomotive activity with the help of piezo-electrical sensor fixed on a bracelet) and video recording which is associated to an informatic treatment of signal in order event recognition.
The aim of study is to realise an objective assessment of activities "go in goal" during experimental sequence which has well-characterized acts, using at the same time an actigraphic record of activity "motive" (system of assessment indirect of apathy fit) and a video records which uses an informatic event recognition system. The assessment will realise with participants controls (n=30) and Alzheimer disease patients with (n=20) or without (n=20) apathy, during well-characterized records. The final aim is to obtain a particular assessment of some disorders behaviours, as apathy, which is principally characterize by a decrease of behaviours "to go in goal".
- Conditions
- Alzheimer Disease
- Being tested
- observational
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationalOther
Observation during a physical exercise
| Study group | Role | What they receive |
|---|---|---|
| witness | Active comparator | no mnesic complaint Receives: Other: observational |
| Alzheimer disease with apathy | Experimental | Alzheimer's disease according to criteria of NINCDS-ADRDA with apathy Receives: Other: observational |
| Alzheimer's disease without apathy | Experimental | Alzheimer's disease according to criteria of NINCDS-ADRDA without apathy Receives: Other: observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
stride and speed walking
Measured: one time point - at the only visit of protocol (day 1)
Secondary outcomes (4)
For comparison between Alzheimer disease patients with (n=20) or without apathy, we use again stride and speed walking
Measured: one time point - at the only visit of protocol (day 1)
For reproducibility, we use stride and speed walking
Measured: one time point - at the only visit of protocol (day 1)
Reliability is the sum of posture's concordance
Measured: one time point - at the only visit of protocol (day 1)
Relation between LF/HF variations and activity index
Measured: one time point - at the only visit of protocol (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 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
- NCT01384344
- Sponsor's protocol ID
- 11-PP-03
- Status last verified
- May 2011
- First submitted
- 27 May 2011
- Last updated
- 18 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ecological Assessment of Apathy in Alzheimer's Disease and in Control Subjects: Interest on Video Recognition and Actigraphy
- ClinicalTrials.gov ID
- NCT01384344
- Acronym / sponsor ID
- 11-PP-03
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 29 Jun 2011 (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 and memory disorders are characterized of Alzheimer disease. In addition, psychologic and behavioural symptoms, called speak neuropsychiatric symptoms, are frequents and play an important role in prognostic and intervention. These symptoms are noticed before the diagnostic of dementia, their prevalence and their intensity increase with the evolution of disease. Apathy, which is characterized by a decrease of motivation, is the most frequent of this behaviour disrupt. Clinically, a decrease, or a totally, lack of interest, initiative and blunting emotional are noticed. Fundamentally, apathy is considered as a decrease of cognition and behaviour to "go in goal". Assessment of psychological and behavioural symptoms is realised principally with neuropsychiatric scales. These contribute to obtain particular informations about health of patient allowing by patient and caregiver discussions and impressions of clinician. These scales are simples but loss of subjectivity. An alternative of this method is the use of gerontechnology as actigraphy (system out-patient which records locomotive activity with the help of piezo-electrical sensor fixed on a bracelet) and video recording which is associated to an informatic treatment of signal in order event recognition.
The aim of study is to realise an objective assessment of activities "go in goal" during experimental sequence which has well-characterized acts, using at the same time an actigraphic record of activity "motive" (system of assessment indirect of apathy fit) and a video records which uses an informatic event recognition system. The assessment will realise with participants controls (n=30) and Alzheimer disease patients with (n=20) or without (n=20) apathy, during well-characterized records. The final aim is to obtain a particular assessment of some disorders behaviours, as apathy, which is principally characterize by a decrease of behaviours "to go in goal".
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| witness | Active comparator | Other: observationalno mnesic complaint |
| Alzheimer disease with apathy | Experimental | Other: observationalAlzheimer's disease according to criteria of NINCDS-ADRDA with apathy |
| Alzheimer's disease without apathy | Experimental | Other: observationalAlzheimer's disease according to criteria of NINCDS-ADRDA without apathy |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (17 listed)
- man or female, more 65 years ;
- no caregiver ;
- no motor handicap ;
- no global cognitive impairment with > 26 MMSE, neither argument in favour of following diagnosis : Alzheimer's disease, major depressive episode ;
- no apathy ;
Key exclusion criteria (3 listed)
- Impossibility of realization of the experimental protocol because of a driving handicap.
- Port(Bearing) of a pacemaker
- Under guardianship Patient or guardianship
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 |
|---|---|---|
| observationalObservation during a physical exercise | Other | Alzheimer disease with apathy, Alzheimer's disease without apathy, witness |
Primary outcome
stride and speed walking
Time frame: one time point - at the only visit of protocol (day 1)
4 secondary outcomes
For comparison between Alzheimer disease patients with (n=20) or without apathy, we use again stride and speed walking
Time frame: one time point - at the only visit of protocol (day 1)
For reproducibility, we use stride and speed walking
Time frame: one time point - at the only visit of protocol (day 1)
Reliability is the sum of posture's concordance
Time frame: one time point - at the only visit of protocol (day 1)
Relation between LF/HF variations and activity index
Time frame: one time point - at the only visit of protocol (day 1)
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 18 Dec 2012.
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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 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 observational in people with Alzheimer 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 17 inclusion and 3 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 18 Dec 2012. 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?
stride and speed walking (time frame: one time point - at the only visit of protocol (day 1)). 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 18 Dec 2012.