Clinical trial NCT01103453: Change in Executive Function and IADL Using a Virtual Supermarket Environment Among People With MCI
Official title: Change in Executive Functions and in Instrumental Activities of Daily Living as a Result of Intervention by Virtual Supermarket Environment Among People With Mild Cognitive Impairment.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Mild Cognitive Impairment
Lack of Physical Activity
Keywords: MCI
Executive Function
ADL
Virtual Supermarket
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2010-04-14
Enrollment: 10
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the feasibility of using a virtual supermarket as an intervention tool for overcoming deficits in executive function as well as enhancing IADL performance among persons with Mild Cognitive Impairment. The working hypotheses are that there will be improvement in executive functions, and the improvement in the executive functions will result in better performance in Instrumental Activities of Daily Living, both generally and especially in shopping task

Detailed description: Scientific and clinical research in the area of Alzheimer's disease (AD) during the last years have shifted their focus to earlier diagnosis and especially to the transitional phase between normal aging and dementia, named Mild Cognitive Impairment (MCI).Lately, the concept of MCI has been expanded to address observed clinical heterogeneity, and subtypes were recognized: amnestic (including memory impairment) and non-amnestic (including impairment in other non-memory cognitive domains), with the later including deficits in executive functioning Executive functions (EF) are defined as higher order functions that are needed for completing complex or non-routine tasks. Deficits in EF refer to a collection of deficits in attention, planning, problem-solving, multitasking, monitoring and behavioral control and persons who suffer from impairments in EF typically have difficulty in initiating or suspending activities, show impaired mental flexibility, as well as increased distractibility and have difficulty in learning novel tasks despite apparently intact cognitive abilities.

Lately, an increasing amount of studies suggest that persons with MCI might have deficits in EF, moreover, persons presenting a combination of executive deficits and memory deficits were found to be a high risk group for conversion to AD.

Eligibility criteria: Inclusion Criteria:

* Age 60+
* Diagnosed as suffering from MCI
* No impaired judgement
* Verbal and written proficiency in Hebrew
* Normal or corrected-to-normal vision and hearing ability
* Independent in ADL function
* Lives in the community
* Able to perform task of shopping.

Exclusion Criteria:

* Suffering from other coexistent neurological diseases (e.g. stroke, muscular dystrophy)
* Has acute arthritis
* Poorly controlled hypothyroidism
* Suffering from physical or sensory limitations, as by self-report or noted by the investigator, that may limit the use of a computer's mouse
* No skills in performing shopping task
* Defined as suffering from depression as determined by the rating scale for depression
* Diagnosed as suffering from dementia as defined by Diagnostic and Statistical Manual of Mental Disorders criteria (DSM-IV)

Primary outcomes:
measure: Improvement in executive functions by means of comparison to the results on the NexAde® computerized test.
timeFrame: 1 month after intervention
Secondary outcomes:
measure: Improved performance in IADL, both generally and especially in shopping task.
timeFrame: 1 month after intervention
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Cognitive Clinic, Carmel Medical Center
Study officials:
affiliation: Carmel Medical center, Haifa, Israel
name: Gary Sinoff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Belleville S. Cognitive training for persons with mild cognitive impairment. Int Psychogeriatr. 2008 Feb;20(1):57-66. doi: 10.1017/S104161020700631X. Epub 2007 Oct 25.
citation: Sgaramella TM, Borgo F, Mondini S, Pasini M, Toso V, Semenza C. Executive deficits appearing in the initial stage of Alzheimer's disease. Brain Cogn. 2001 Jun-Jul;46(1-2):264-8. doi: 10.1016/s0278-2626(01)80080-4.
citation: Josman N, Schenirderman AE, Klinger E, Shevil E. Using virtual reality to evaluate executive functioning among persons with schizophrenia: a validity study. Schizophr Res. 2009 Dec;115(2-3):270-7. doi: 10.1016/j.schres.2009.09.015. Epub 2009 Oct 22.
citation: Werner P, Rabinowitz S, Klinger E, Korczyn AD, Josman N. Use of the virtual action planning supermarket for the diagnosis of mild cognitive impairment: a preliminary study. Dement Geriatr Cogn Disord. 2009;27(4):301-9. doi: 10.1159/000204915. Epub 2009 Mar 2.