Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00146263
Status:
WITHDRAWN
Last Update Posted:
2020-02-27
First Post:
2005-09-04
Brief Title:
Computerized Cognitive Training in the Elderly
Sponsor:
Beersheva Mental Health Center
Organization:
Beersheva Mental Health Center
Study Overview
Official Title:
The Effect of Computerized Cognitive Training on Neuropsychological Measures of Cognitive Function in the Elderly
Status:
WITHDRAWN
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty in enrolling subjects in the proposed crossover study design
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CogTrain
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 ABBA 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
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 ABBA 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 ABBA 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 ABBA 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 NY 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
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 ABBA 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 ABBA 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 NY 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None