MedDataX Logo

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

NCT ID: NCT01384344

Last Updated: 2012-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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".

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

witness

no mnesic complaint

Group Type ACTIVE_COMPARATOR

observational

Intervention Type OTHER

Observation during a physical exercise

Alzheimer disease with apathy

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

Group Type EXPERIMENTAL

observational

Intervention Type OTHER

Observation during a physical exercise

Alzheimer's disease without apathy

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

Group Type EXPERIMENTAL

observational

Intervention Type OTHER

Observation during a physical exercise

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

observational

Observation during a physical exercise

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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 ;
* 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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Philippe ROBERT, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hôpital de Cimiez

Nice, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

11-PP-03

Identifier Type: -

Identifier Source: org_study_id