NCT00337909

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
Last Updated

November 2, 2015

Status Verified

October 1, 2015

Enrollment Period

6 months

First QC Date

June 15, 2006

Last Update Submit

October 29, 2015

Conditions

Aging

Keywords

cognitive enhancementmemoryauditory memoryspeechcomputerized

Outcome Measures

Primary Outcomes (1)

  • Evaluation of training program.

Secondary Outcomes (1)

  • Evaluation of training effects.

Study Arms (3)

Experimental Treatment

EXPERIMENTAL

Computerized Plasticity-Based Adaptive Cognitive Training

Other: Computerized Plasticity-Based Adaptive Cognitive Training

Active Control

ACTIVE COMPARATOR

Educational DVDs

Other: Educational DVDs

No Contact Control

NO INTERVENTION

Interventions

Computerized Plasticity-Based Adaptive Cognitive TrainingOTHER
Also known as: BrainHQ, Brain Fitness Program
Experimental Treatment
Educational DVDsOTHER
Active Control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Posit Science Corporation

San Francisco, California, 94108, United States

Location

Related Publications (1)

  • Mahncke HW, Bronstone A, Merzenich MM. Brain plasticity and functional losses in the aged: scientific bases for a novel intervention. Prog Brain Res. 2006;157:81-109. doi: 10.1016/S0079-6123(06)57006-2.

    PMID: 17046669RESULT

MeSH Terms

Conditions

Speech

Condition Hierarchy (Ancestors)

Verbal BehaviorCommunicationBehavior

Study Officials

  • Henry W Mahncke, PhD

    Posit Science Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2006

First Posted

June 20, 2006

Study Start

September 1, 2005

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

November 2, 2015

Record last verified: 2015-10

Locations

US(1)