- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00337974
Computer-Based Training for Cognitive Enhancement: In Home Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The computer-based training program is focused on speech reception to strengthen an individual's memory for speech. This type of training program was chosen because speech perception and memory are crucial elements of human communication and losses in this area are often the first signal of overall cognitive decline.
Subjects meeting eligibility criteria and providing written, informed consent are randomized to three groups; two 40-session, computerized training programs or a no contact control group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94108
- Posit Science Corporation
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
A)Participants must be at least 60 years old B)Participants must have a Mini-Mental State Exam (MMSE) score of 24 or higher to ensure that participants do not meet common criteria for dementia C)Participants must be a native English speaker D)Participants must be able to see well enough to read the consent form E)Participants must be able to hear well enough to understand ordinary spoken conversation in a slightly noisy room F)Participants must be willing to commit to the time requirements of the study and not have any scheduled trips or absences for more than 1 week during the training.
Exclusion Criteria A)Participants must not be planning to begin cholinesterase inhibitor (AChEI) therapy or to change their dosing levels. Subjects currently using AChEI will be included if they have an established steady dosing history at least one month prior to the study and are expected to continue at the same dosage throughout the study.
B)Participants must not have had a head trauma that caused them to lose consciousness.
C)Participants must not have had a stroke within the past year; or have had a stroke that has left them with expressive or receptive language problems.
D)Participants must not have any central nervous system disorder that could contribute to cognitive impairment.
E)Participants must not have a tremor preventing the use of a computer mouse or other pointing device.
F)Participants must not currently be active in another clinical trial.
Exclusion Criteria:
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental Treatment
Computerized Plasticity-Based Adaptive Cognitive Training
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Other Names:
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Active Comparator: Active Control
Educational DVDs
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No Intervention: No Contact Control
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
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Evaluation of training effects.
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Secondary Outcome Measures
Outcome Measure |
|---|
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Safety effects of computer-based training.
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- OUT-106-2005
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