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Completed

NCT Number: NCT01384344

Ecological Assessment of Apathy in Alzheimer's Disease and in Control Subjects: 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".

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital de Cimiez

Nice, 06000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational

Other

Observation during a physical exercise

Primary outcomes

  1. stride and speed walking

    Time frame: one time point - at the only visit of protocol (day 1)

Secondary outcomes

  1. 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)

  2. For reproducibility, we use stride and speed walking

    Time frame: one time point - at the only visit of protocol (day 1)

  3. Reliability is the sum of posture's concordance

    Time frame: one time point - at the only visit of protocol (day 1)

  4. Relation between LF/HF variations and activity index

    Time frame: one time point - at the only visit of protocol (day 1)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Ecological Assessment of Apathy in Alzheimer's Disease and in Control Subjects: Interest on Video Recognition and Actigraphy

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Jun 29, 2011
Registry last updated
Dec 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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