Contribution of Actigraphy and Recognition Video in Apathy Assessment of Alzheimer's Disease : Experimental Research (09-PP-06)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Centre Hospitalier Universitaire de Nice

ClinicalTrials.gov Identifier:

NCT01049555

First received: January 12, 2010

Last updated: September 29, 2015

Last verified: September 2015

History of Changes

Purpose

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 .

Condition	Intervention
Alzheimer's Disease	Other: Actigraphy and video recording signal


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	Contribution of Actigraphy and Recognition Video in Apathy Assessment of Alzheimer's Disease : Experimental Research

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Health Checkup

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:

assessment of motricity [ Time Frame: one time point - at the only visit of protocol ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

video recording [ Time Frame: one time point - at the only visit of the protocol ] [ Designated as safety issue: No ]


Enrollment:	42
Study Start Date:	September 2011
Study Completion Date:	December 2012
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Alzheimer and apathy Alzheimer's disease patients with apathy	Other: Actigraphy and video recording signal Actigraphy and video recording signal during 1 hour
alzheimer without disease Alzheimer's disease patients without apathy	Other: Actigraphy and video recording signal Actigraphy and video recording signal during 1 hour
Case control subject without apathy neither Alzheimer's disease	Other: Actigraphy and video recording signal Actigraphy and video recording signal during 1 hour

Eligibility


Ages Eligible for Study:	65 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01049555

Locations


France
Nice University Hospital
Nice, France, 06000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

Investigators


Principal Investigator:	Philippe ROBERT, PU-PH	Nice University Hospital

More Information


Responsible Party:	Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:	NCT01049555 History of Changes
Other Study ID Numbers:	09-PP-06
Study First Received:	January 12, 2010
Last Updated:	September 29, 2015
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: French Data Protection Authority France: Institutional Ethical Committee

Keywords provided by Centre Hospitalier Universitaire de Nice:


alzheimer apathy actigraphy

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 29, 2016

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