Clinical trial NCT00526942: Behavioral and Physiological Effects of Visual Training
Official title: Computer-Based Cognitive Training in Normal Healthy Aging: Pilot Study of Behavioral and Physiological Effects of Visual Sweeps Training Exercise, 2-Arm Model
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Healthy
Keywords: ACRD
Visual Memory
Visual Perception
Speed
Computerized
SAAGE
Cognitive Decline
Lead sponsor: Posit Science Corporation
Sponsor class: INDUSTRY
Collaborators: name: University of San Francisco
First posted: 2007-09-10
Enrollment: 54
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Virtually all adults will suffer a decline in their cognitive capacities to some degree. Typically, cognitive decline is characterized by a slow, progressive decline in abilities (frequently in memory, attention, inhibition and speed of processing) relative to younger adults, commonly called normal aging, age-associated memory impairment, age-consistent memory impairment, benign senescent forgetfulness, late-life forgetfulness, ageing-associated cognitive decline, and the preferred term, age-related cognitive decline (ARCD) As virtually all adults experience a reduction in their cognitive abilities with age, ARCD has generally been considered to be a normal, inevitable, and irreversible part of aging; and the extremely severe forms of pathological cognitive decline (e.g., Alzheimer's disease, AD) have dominated therapeutic research in this area. However, ARCD represents an important cause of quality of life decline in almost every older adult, as the impact of forgetfulness and mental slowing increasingly change the abilities of individuals to successfully manage their day-to-day activities. Therapeutic approaches targeting the specific problems of ARCD in normal aging (as opposed to the pathological problems of AD) would unto themselves represent important clinical advances.

This trial investigates the effects of a computer-based visual training exercise built on the principles of positive brain plasticity and designed for use by healthy mature individuals. The program is specifically designed to improve the fidelity of sensory representations in early visual cortex.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Improvement in visual memory assessment after training or no-contact period.
timeFrame: 6-8 weeks
Secondary outcomes:
measure: Improvement on at least 1 of the Computerized Visual Attention, Speed and Memory Tests conducted.
timeFrame: 6-8 weeks
measure: Improvement on the computerized cognitive assessments.
timeFrame: 6-8 weeks
measure: Improvement on exercise-based assessments.
timeFrame: 6-8 weeks
Other outcomes:
Locations:
city: San Francisco Bay Area
country: United States
facility: Posit Science Corporation
state: California
Study officials:
affiliation: Posit Science Corporation
name: Joseph L Hardy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.