Ecological Assessment of Apathy in Alzheimer's Disease and in Control Subjects: Video Recognition and Actigraphy
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Purpose
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".
| Condition | Intervention |
|---|---|
|
Alzheimer Disease |
Other: observational |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Ecological Assessment of Apathy in Alzheimer's Disease and in Control Subjects: Interest on Video Recognition and Actigraphy |
- stride and speed walking [ Time Frame: one time point - at the only visit of protocol (day 1) ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
- For reproducibility, we use stride and speed walking [ Time Frame: one time point - at the only visit of protocol (day 1) ] [ Designated as safety issue: No ]
- Reliability is the sum of posture's concordance [ Time Frame: one time point - at the only visit of protocol (day 1) ] [ Designated as safety issue: No ]
- Relation between LF/HF variations and activity index [ Time Frame: one time point - at the only visit of protocol (day 1) ] [ Designated as safety issue: No ]
| Enrollment: | 82 |
| Study Start Date: | June 2011 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: witness
no mnesic complaint
|
Other: observational
Observation during a physical exercise
|
|
Experimental: Alzheimer disease with apathy
Alzheimer's disease according to criteria of NINCDS-ADRDA with apathy
|
Other: observational
Observation during a physical exercise
|
|
Experimental: Alzheimer's disease without apathy
Alzheimer's disease according to criteria of NINCDS-ADRDA without apathy
|
Other: observational
Observation during a physical exercise
|
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria for no mnesic patient:
- 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 ;
- signature of informed consent.
Inclusion Criteria for Alzheimer's patient:
- 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.
Exclusion Criteria:
- Impossibility of realization of the experimental protocol because of a driving handicap.
- Port(Bearing) of a pacemaker
- Under guardianship Patient or guardianship
Contacts and Locations More Information
No publications provided
| Responsible Party: | Centre Hospitalier Universitaire de Nice |
| ClinicalTrials.gov Identifier: | NCT01384344 History of Changes |
| Other Study ID Numbers: | 11-PP-03 |
| Study First Received: | May 27, 2011 |
| Last Updated: | December 17, 2012 |
| Health Authority: | France: Committee for the Protection of Personnes |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013