Study Stopped
Difficulty in enrolling subjects in the proposed crossover study design
Computerized Cognitive Training in the Elderly
CogTrain
The Effect of Computerized Cognitive Training on Neuropsychological Measures of Cognitive Function in the Elderly
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2005
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 4, 2005
CompletedFirst Posted
Study publicly available on registry
September 7, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFebruary 27, 2020
February 1, 2020
2.2 years
September 4, 2005
February 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Computerized cognitive assessment using the Mindstreams battery
Changes in cognitive function including memory, executive function, visual spatial and attention.
12 weeks
Study Arms (2)
Savyon
ACTIVE COMPARATORComputerized cognitive training using the Savyon software
Control
PLACEBO COMPARATORUsual activity
Interventions
Eligibility Criteria
You may qualify if:
- Age: above 60 years old
You may not qualify if:
- Visual impairment
- Educational inability to perform training
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beersheva Mental Health Center
Beersheva, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tzvi Dwolatzky, MD
Ben-Gurion University of the Negev
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 4, 2005
First Posted
September 7, 2005
Study Start
September 1, 2005
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
February 27, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share