Computerized Cognitive Training in the Elderly

NCT ID: NCT00146263

Last Updated: 2020-02-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2007-12-31

Brief Summary

Background:

The aging of the population has lead to a significant increase in the number of older people suffering from cognitive impairment and dementia. The present lack of effective drug therapy for these conditions makes it imperative to investigate other potential therapeutic interventions.

Cognitive training has been described as possibly useful in improving cognitive function in elderly subjects with mild impairment and early dementia. However, there have been few well-designed studies to date and the results are equivocal. Most studies have relied on the use of paper-based neuropsychological assessment instruments with limited accuracy and reproducibility. The investigators have developed a validated computerized neuropsychological assessment battery with increased test-retest reliability.

The purpose of this study is to assess the efficacy of a computerized training program on cognitive function in older persons with normal cognition, mild cognitive impairment, and early dementia.

Description:

A randomized prospective AB/BA crossover study.

Methods:

Eligible males and females aged 60 years and older following initial computerized neuropsychological assessment will be randomized to receive either a 12-session computerized cognitive training program, or no treatment. Repeat neuropsychological assessment will be followed by a 4-week no treatment phase, reassessment and crossover phase.

Detailed Description

Background

In recent years there has been an increase in the elderly population. This fact has led to a significant number of people suffering from diseases which are associated with old age, amongst which is dementia.

The medical treatment of dementia is limited in its effectiveness and thus it is important to investigate other methods of therapy. One of the possible options to preserve the cognitive function is to apply cognitive exercise. If these exercises can improve cognitive expertise, it would open new vistas of treatment for dementia patients.

From a few research projects that have taken place on the subject, it has not been proved that cognitive exercising has been of use to patients suffering from mild dementia mainly because of methodological restraints. Thus it is necessary to undertake controlled random research on the subject.

The assessment of the cognitive state and the change in its status demands sensitive measurements. Objective and accurate computerized neuro-physiological testing like "Mindstream ®" and computer hardware are readably available. This technique enhances motivation and encourages participation.

Purpose of the work:

To evaluate the influence of computerized cognitive exercise on the cognitive function of the elderly suffering from mild dementia.

Methods:

IA randomized controlled study using a crossover AB/BA design will be performed. The intervention group will participate in a 12-session twice weekly intervention using the "Savyon" computerized cognitive training program (developed by the Melabev organization Jerusalem), which includes memory, language, arithmetic exercises and puzzles matching colors and shapes. The control group will continue with usual activities with no additional cognitive stimulation. Following a 4-week "washout" phase the groups will be switched in an AB/BA crossover design. A total of 150 subjects with mild cognitive impairment or early dementia will be included. Primary outcome measure will be the Mindstreams® (NeuroTrax Corp., N.Y.) computerized cognitive assessment battery performed initially, at 12 weeks, 16 weeks, 28 weeks.

For each Mindstreams ® index, the differences were compared the testing within each group utilizing "Wilcoxon Signed Ranks test" and between the groups utilizing "Mann-Whitney U test".

Conditions

Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Savyon

Computerized cognitive training using the Savyon software

Group Type: ACTIVE_COMPARATOR

Savyon

Intervention Type: BEHAVIORAL

Computerized cognitive training

Control

Usual activity

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: BEHAVIORAL

Usual activity

Interventions

Savyon

Computerized cognitive training

Intervention Type: BEHAVIORAL

Control

Usual activity

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age: above 60 years old

Exclusion Criteria

• Visual impairment
• Educational inability to perform training

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beersheva Mental Health Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Tzvi Dwolatzky

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tzvi Dwolatzky, MD

Role: PRINCIPAL_INVESTIGATOR

Ben-Gurion University of the Negev

Locations

Beersheva Mental Health Center

Beersheva, , Israel

Countries

Israel

Other Identifiers

BMHC-4018CTIL

Identifier Type: -

Identifier Source: org_study_id