Computer-Based Training for Cognitive Enhancement: Audio Training Version .6D4.R
|First Received Date ICMJE||June 15, 2006|
|Last Updated Date||June 15, 2006|
|Start Date ICMJE||September 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Evaluation of training program.|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
||Evaluation of training effects.|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Computer-Based Training for Cognitive Enhancement: Audio Training Version .6D4.R|
|Official Title ICMJE||Computer-Based Training for Cognitive Enhancement: Audio Training Version .6D4.R|
The primary objective of this study is to evaluate the design and effectiveness of a computer-based training program on the memory and cognitive abilities of mature individuals undergoing healthy aging.
The purpose of this study is to test the new progressions design of a computer-based training program and to demonstrate the effectiveness of this refined cognitive training regimen on participants’ performance on normed neuropsychological measures.
Subjects meeting eligibility criteria and providing written, informed consent will complete 40 one hour sessions of a computer based training program.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Educational/Counseling/Training
|Condition ICMJE||Cognitive Decline|
|Intervention ICMJE||Procedure: Computer-based training for cognitive enhancement|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||March 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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 when the clinical specialist holds a paper in front of his or her face to prevent the participant from lip-reading.
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.
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 in the past five years and have had no subsequent symptoms.
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.
|Ages||60 Years and older|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00337909|
|Other Study ID Numbers ICMJE||OUT-107-2005|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Posit Science Corporation|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Posit Science Corporation|
|Verification Date||June 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP