Computer-Based Training for Cognitive Enhancement: In Home Study

Aging Clinical Trial

Official title:

Computer-Based Training for Cognitive Enhancement: In Home Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00337974
• Other study ID #: OUT-106-2005
• Status: Completed
• Phase: N/A
• First received: June 15, 2006
• Last updated: October 29, 2015
• Start date: March 2005
• Est. completion date: January 2006

Study information

• Verified date: October 2015
• Source: Posit Science Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aging

Intervention

Other:
• Computerized Plasticity-Based Adaptive Cognitive Training

• Educational DVDs

Locations

Country	Name	City	State
United States	Posit Science Corporation	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Posit Science Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Mahncke HW, Connor BB, Appelman J, Ahsanuddin ON, Hardy JL, Wood RA, Joyce NM, Boniske T, Atkins SM, Merzenich MM. Memory enhancement in healthy older adults using a brain plasticity-based training program: a randomized, controlled study. Proc Natl Acad S — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of training effects.
Secondary	Safety effects of computer-based training.