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

NCT01384344 | Completed

• 1 other identifier: 11-PP-03
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• stride and speed walking

  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

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

• For reproducibility, we use stride and speed walking

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

• Reliability is the sum of posture's concordance

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

• Relation between LF/HF variations and activity index

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

Study Arms (3)

witness

ACTIVE COMPARATOR

no mnesic complaint

Other: observational

Alzheimer disease with apathy

EXPERIMENTAL

Alzheimer's disease according to criteria of NINCDS-ADRDA with apathy

Other: observational

Alzheimer's disease without apathy

EXPERIMENTAL

Alzheimer's disease according to criteria of NINCDS-ADRDA without apathy

Other: observational

Interventions

observational OTHER

Observation during a physical exercise

Alzheimer disease with apathy; Alzheimer's disease without apathy; witness

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.
• 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 ;

You may not qualify if:

• Impossibility of realization of the experimental protocol because of a driving handicap.
• Port(Bearing) of a pacemaker
• Under guardianship Patient or guardianship

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Hôpital de Cimiez

Nice, 06000, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Philippe ROBERT, PU-PH

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2011
• First Posted: June 29, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2012
• Last Updated: December 18, 2012

Record last verified: 2011-05

Locations

FR (1)