Computer-Based Training for Cognitive Enhancement: Classroom Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Posit Science Corporation
ClinicalTrials.gov Identifier:
NCT00337909
First received: June 15, 2006
Last updated: October 29, 2015
Last verified: October 2015
  Purpose
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.

Condition Intervention
Aging
Other: Computerized Plasticity-Based Adaptive Cognitive Training
Other: Educational DVDs

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Computer-Based Training for Cognitive Enhancement: Classroom Study

Further study details as provided by Posit Science Corporation:

Primary Outcome Measures:
  • Evaluation of training program.

Secondary Outcome Measures:
  • Evaluation of training effects.

Enrollment: 94
Study Start Date: September 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Treatment
Computerized Plasticity-Based Adaptive Cognitive Training
Other: Computerized Plasticity-Based Adaptive Cognitive Training
Other Names:
  • BrainHQ
  • Brain Fitness Program
Active Comparator: Active Control
Educational DVDs
Other: Educational DVDs
No Intervention: No Contact Control

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 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.

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 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337909

Locations
United States, California
Posit Science Corporation
San Francisco, California, United States, 94108
Sponsors and Collaborators
Posit Science Corporation
Investigators
Principal Investigator: Henry W Mahncke, PhD Posit Science Corporation
  More Information

Publications:
Responsible Party: Posit Science Corporation
ClinicalTrials.gov Identifier: NCT00337909     History of Changes
Other Study ID Numbers: OUT-107-2005 
Study First Received: June 15, 2006
Last Updated: October 29, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Posit Science Corporation:
cognitive enhancement
memory
auditory memory
speech
computerized

ClinicalTrials.gov processed this record on July 21, 2016