Dementia Clinical Trial
Official title:
The Effect of Computerized Cognitive Training on Neuropsychological Measures of Cognitive Function in the Elderly
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.
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".
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