Contribution of Actigraphy and Recognition Video in Apathy Assessment of Alzheimer's Disease : Experimental Research

Alzheimer's Disease Clinical Trial

— 09-PP-06  

Official title:

Contribution of Actigraphy and Recognition Video in Apathy Assessment of Alzheimer's Disease : Experimental Research

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01049555
• Other study ID #: 09-PP-06
• Status: Completed
• Phase: N/A
• First received: January 12, 2010
• Last updated: September 29, 2015
• Start date: September 2011
• Est. completion date: December 2012

Study information

• Verified date: September 2015
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection AuthorityFrance: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial Summary

Neuropsychiatric symptoms form part of the clinical picture of Alzheimer's disease (AD) and other dementias. Irrespective of the severity of the disease, the most frequently encountered symptom is apathy. Apathy is increasingly diagnosed in patients with neurological and psychiatric conditions. Apathy is a disorder of motivation, defined as "the direction, intensity and persistence of goal-directed behaviour". Most of the current descriptions acknowledge this point and consider apathy in terms of a lack of goal-directed behaviour, cognition or emotion. The classical neuropsychiatric symptom assessments are subjective structured interview-based, using input from the caregiver and/or the patient. New technologies are likely to provide us with a more objective measure. An example is ambulatory actigraphy, consisting of a piezoelectric accelerometer designed to record arm movement in three dimensions.

The aim of the present study is to assess using actigraphy and video recording signal, AD patients with (n = 15) and without (n = 15) apathy and control subjects (n = 5) during an activity of daily living scenario .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• male or female, > 65 years ;

• Alzheimer's disease according to the NINCDS-ADRDA criteria (McKhann,Drachman et al. 1984) ;

• Mini Mental Test Examination (MMSE) > 20 ;

• no motor anomaly according to UPDRS III (tremblements, rigidité musculaire) ;

• no depression criteria according to DSM IV-R criteria ;

• patient with a cholinergic treatment at dose stable since 3 months ;

• patient with social insurance ;

• signature of informed consent.

Exclusion Criteria:

• neuropsychologics assessment impossible due to sensorial and disrupt ;

• prescription of psychotrop treatment (hypnotic, anxiolytic, antidepressant, antipsychotic) in the week previous actigraphy recording.

Study Design

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Other:
• Actigraphy and video recording signal
Actigraphy and video recording signal during 1 hour

Locations

Country	Name	City	State
France	Nice University Hospital	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	assessment of motricity		one time point - at the only visit of protocol	No
Secondary	video recording		one time point - at the only visit of the protocol	No