Computer-Based Training for Cognitive Enhancement
|First Received Date ICMJE||June 15, 2006|
|Last Updated Date||June 15, 2006|
|Start Date ICMJE||March 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Evaluation of training effects.|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
||Safety effects of computer-based training.|
|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|
|Official Title ICMJE||Computer-Based Training for Cognitive Enhancement In the Elderly: In Home and In Office Pilot Studies|
The primary objective of this study is to evaluate the effects of a computer-based training program on the memory and cognitive abilities of mature individuals undergoing healthy aging.
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 ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel 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||January 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 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.
|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||NCT00337974|
|Other Study ID Numbers ICMJE||OUT 106-2005|
|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