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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01384344
• Other study ID #: 11-PP-03
• Status: Completed
• Phase: N/A
• First received: May 27, 2011
• Last updated: December 17, 2012
• Start date: June 2011
• Est. completion date: June 2012

Study information

• Verified date: May 2011
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical 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. 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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Other:
• observational
Observation during a physical exercise

Locations

Country	Name	City	State
France	Hôpital de Cimiez	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stride and speed walking		one time point - at the only visit of protocol (day 1)	No
Secondary	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)	No
Secondary	For reproducibility, we use stride and speed walking		one time point - at the only visit of protocol (day 1)	No
Secondary	Reliability is the sum of posture's concordance		one time point - at the only visit of protocol (day 1)	No
Secondary	Relation between LF/HF variations and activity index		one time point - at the only visit of protocol (day 1)	No