NCT00526942

Brief Summary

The primary objective of this study is to evaluate the learnability of a 3 week, 40 minutes per day, 5 day per week, computer-based visual training exercise by healthy mature individuals undergoing normal aging.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Aug 2007

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 6, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

September 11, 2007

Status Verified

September 1, 2007

First QC Date

September 6, 2007

Last Update Submit

September 10, 2007

Conditions

Healthy

Keywords

ACRDVisual MemoryVisual PerceptionSpeedComputerizedSAAGECognitive Decline

Outcome Measures

Primary Outcomes (1)

  • Improvement in visual memory assessment after training or no-contact period.

    6-8 weeks

Secondary Outcomes (3)

  • Improvement on at least 1 of the Computerized Visual Attention, Speed and Memory Tests conducted.

    6-8 weeks

  • Improvement on the computerized cognitive assessments.

    6-8 weeks

  • Improvement on exercise-based assessments.

    6-8 weeks

Study Arms (2)

I

NO INTERVENTION

No contact control (NCC)

II

EXPERIMENTAL

Computerized, SAAGE-designed, visual memory-based cognitive training

Behavioral: SAAGE-designed, visual memory-based cognitive training

Interventions

SAAGE-designed, visual memory-based cognitive trainingBEHAVIORAL

Training sessions take 40 minutes per day, five days per week for a total goal of 15, 40-minute sessions.

Also known as: Hawkeye
II

Eligibility Criteria

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

You may qualify if:

  • Age 60 or older at the time of consent.
  • Mini-Mental Status Examination (MMSE) score of 26 or higher.
  • Adequate visual capacity adequate to read.
  • Adequate hearing capacity.
  • Willing and able to commit to study time requirements.

You may not qualify if:

  • Self-report of current diagnosis or history of major neurological illness.
  • Self-report of current diagnosis or history of psychiatric illness. c. History of psychiatric hospitalization in the past twenty years.
  • 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. - Fibromyalgia or symptoms of severe tremor.
  • Self-report of current substance abuse, including alcoholism.
  • Current useof medications with substantial CNS effects. Inappropriate behaviors during screening or baseline visits.
  • Inability to perform behavioral evaluations.
  • Participant is not capable of giving informed consent or unable to comprehend and/or follow instructions.
  • Participant is enrolled in a concurrent clinical study that could affect the outcome of this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Posit Science Corporation

San Francisco Bay Area, California, 94104, United States

RECRUITING

Related Publications (5)

  • Bischkopf J, Busse A, Angermeyer MC. Mild cognitive impairment--a review of prevalence, incidence and outcome according to current approaches. Acta Psychiatr Scand. 2002 Dec;106(6):403-14. doi: 10.1034/j.1600-0447.2002.01417.x.

    PMID: 12392483BACKGROUND

  • Fillit HM, Butler RN, O'Connell AW, Albert MS, Birren JE, Cotman CW, Greenough WT, Gold PE, Kramer AF, Kuller LH, Perls TT, Sahagan BG, Tully T. Achieving and maintaining cognitive vitality with aging. Mayo Clin Proc. 2002 Jul;77(7):681-96. doi: 10.4065/77.7.681.

    PMID: 12108606BACKGROUND

  • Ahissar E, Nagarajan S, Ahissar M, Protopapas A, Mahncke H, Merzenich MM. Speech comprehension is correlated with temporal response patterns recorded from auditory cortex. Proc Natl Acad Sci U S A. 2001 Nov 6;98(23):13367-72. doi: 10.1073/pnas.201400998.

    PMID: 11698688BACKGROUND

  • Park HL, O'Connell JE, Thomson RG. A systematic review of cognitive decline in the general elderly population. Int J Geriatr Psychiatry. 2003 Dec;18(12):1121-34. doi: 10.1002/gps.1023.

    PMID: 14677145BACKGROUND

  • Scarmeas N, Stern Y. Cognitive reserve: implications for diagnosis and prevention of Alzheimer's disease. Curr Neurol Neurosci Rep. 2004 Sep;4(5):374-80. doi: 10.1007/s11910-004-0084-7.

    PMID: 15324603BACKGROUND

Related Links

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Joseph L Hardy, PhD

    Posit Science Corporation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Tinker, BS

CONTACT

4153943100daniel.tinker@positscience.com

Cate Stasio, BA

CONTACT

4153943100cate.stasio@positscience.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 6, 2007

First Posted

September 10, 2007

Study Start

August 1, 2007

Study Completion

August 1, 2008

Last Updated

September 11, 2007

Record last verified: 2007-09

Locations

US(1)