Computerized Cognitive Training in the Elderly (CogTrain)
Primary Purpose
Dementia
Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Savyon
Control
Sponsored by
About this trial
This is an interventional treatment trial for Dementia focused on measuring mild cognitive impairment, dementia, Alzheimer's Disease, cognitive training
Eligibility Criteria
Inclusion Criteria: Age: above 60 years old Exclusion Criteria: Visual impairment Educational inability to perform training
Sites / Locations
- Beersheva Mental Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Savyon
Control
Arm Description
Computerized cognitive training using the Savyon software
Usual activity
Outcomes
Primary Outcome Measures
Computerized cognitive assessment using the Mindstreams battery
Changes in cognitive function including memory, executive function, visual spatial and attention.
Secondary Outcome Measures
Full Information
NCT ID
NCT00146263
First Posted
September 4, 2005
Last Updated
February 24, 2020
Sponsor
Beersheva Mental Health Center
1. Study Identification
Unique Protocol Identification Number
NCT00146263
Brief Title
Computerized Cognitive Training in the Elderly
Acronym
CogTrain
Official Title
The Effect of Computerized Cognitive Training on Neuropsychological Measures of Cognitive Function in the Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulty in enrolling subjects in the proposed crossover study design
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beersheva Mental Health Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
mild cognitive impairment, dementia, Alzheimer's Disease, cognitive training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Savyon
Arm Type
Active Comparator
Arm Description
Computerized cognitive training using the Savyon software
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Usual activity
Intervention Type
Behavioral
Intervention Name(s)
Savyon
Intervention Description
Computerized cognitive training
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Usual activity
Primary Outcome Measure Information:
Title
Computerized cognitive assessment using the Mindstreams battery
Description
Changes in cognitive function including memory, executive function, visual spatial and attention.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age: above 60 years old
Exclusion Criteria:
Visual impairment
Educational inability to perform training
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tzvi Dwolatzky, MD
Organizational Affiliation
Ben-Gurion University of the Negev
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beersheva Mental Health Center
City
Beersheva
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
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Computerized Cognitive Training in the Elderly
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