NCT00283010

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
487

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2006

Typical duration 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

January 1, 2006

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

November 2, 2015

Status Verified

October 1, 2015

Enrollment Period

2.2 years

First QC Date

January 25, 2006

Last Update Submit

October 29, 2015

Conditions

Keywords

cognitive enhancementmemoryauditory memoryspeechcomputerizedcognitive decline

Outcome Measures

Primary Outcomes (1)

  • Cognitive effects of training

    6 months

Secondary Outcomes (1)

  • Safety effects of computer-based training

    6 months

Study Arms (2)

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

Interventions

Also known as: BrainHQ, Brain Fitness Program
Experimental Treatment
Active Control

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65 or older at the time of consent.
  • Mini-Mental State Examination (MMSE) score of 26 or higher.
  • Fluent English speaker. For the purposes of this study, fluency will be defined as living in an English speaking country and attending an English speaking school by the age of six (participants will demonstrate fluency by reading aloud a selected paragraph).
  • Visual capacity adequate to read 14 point type (participants will demonstrate visual capacity by reading aloud a selected sentence).
  • Adequate hearing capacity. (Participants will demonstrate by repeating a series of words spoken by the screening clinician; the words will be spoken while a view of the clinician's mouth is obstructed to prevent lip-reading.)
  • Willing and able to commit to the 6-month time requirement of the entire study period with an emphasis on availability for the 8-10 week computer based training.

You may not qualify if:

  • Mini-Mental State Examination (MMSE) score of 25 or lower.
  • Self-report of current diagnosis or history of major neurological illness. Specifically:
  • Alzheimer's disease
  • Parkinson's disease
  • Multiple sclerosis
  • Amyotrophic lateral sclerosis
  • Self-report of current diagnosis or history of psychiatric illness. Specifically:
  • Major depressive disorder
  • Bipolar disorder
  • Schizophrenia
  • Post traumatic stress disorder
  • Obsessive-compulsive disorder
  • Self-reported history of psychiatric hospitalization.
  • History of a stroke, transient ischemic attack (TIA), or traumatic brain injury within the past year; or lifetime history of stroke, TIA, or traumatic brain injury that has left residual expressive or receptive language problems. Traumatic brain injuries include, but are not limited to: concussion with loss of consciousness; head trauma with loss of consciousness; persistent migraines (persistent being defined as a predictable pattern occurring more frequently than every other month); and history of seizure disorder.
  • Fibromyalgia or symptoms of tremor severe enough to prevent the use of a computer mouse or other pointing device. Clinician to observe participant during signature of consent form, during drawing portion of Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) assessment, and to directly ask participant as instructed in the Body Image Ideals Questionnaire (BIQ) to make tremor assessment.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Posit Science Corporation

San Francisco, California, 94108, United States

Location

Related Publications (3)

  • Smith GE, Housen P, Yaffe K, Ruff R, Kennison RF, Mahncke HW, Zelinski EM. A cognitive training program based on principles of brain plasticity: results from the Improvement in Memory with Plasticity-based Adaptive Cognitive Training (IMPACT) study. J Am Geriatr Soc. 2009 Apr;57(4):594-603. doi: 10.1111/j.1532-5415.2008.02167.x. Epub 2009 Feb 9.

  • Zelinski EM, Spina LM, Yaffe K, Ruff R, Kennison RF, Mahncke HW, Smith GE. Improvement in memory with plasticity-based adaptive cognitive training: results of the 3-month follow-up. J Am Geriatr Soc. 2011 Feb;59(2):258-65. doi: 10.1111/j.1532-5415.2010.03277.x.

  • Zelinski EM, Peters KD, Hindin S, Petway KT 2nd, Kennison RF. Evaluating the relationship between change in performance on training tasks and on untrained outcomes. Front Hum Neurosci. 2014 Aug 13;8:617. doi: 10.3389/fnhum.2014.00617. eCollection 2014.

MeSH Terms

Conditions

SpeechCognitive Dysfunction

Condition Hierarchy (Ancestors)

Verbal BehaviorCommunicationBehaviorCognition DisordersNeurocognitive DisordersMental Disorders

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

January 25, 2006

First Posted

January 27, 2006

Study Start

January 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

November 2, 2015

Record last verified: 2015-10

Locations