Clinical trial NCT00319943: Computer-Based Therapy for Mild Cognitive Impairment
Official title: Computer-Based Therapy for Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mild Cognitive Impairment
Keywords: Cognitive remediation
Cognitive impairment
computer
training
Lead sponsor: Posit Science Corporation
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
name: University of California, Davis
name: Stanford University
First posted: 2006-04-27
Enrollment: 48
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the neuropsychological and neurophysiological impacts of a computer-based training program designed to improve the cognitive performance of patients with mild cognitive impairment (MCI).

Detailed description: The study is a randomized, double-blind, controlled trial of a computerized, cognitive intervention with three main goals: 1) to assess the magnitude of improvements in memory, language function, and cognitive function following computer training, 2) to investigate the neurophysiological mechanisms underlying such neuropsychological improvements, and 3) to demonstrate the feasibility of using this kind of computer-based therapy in older populations.

Eligibility criteria: Inclusion Criteria:

1)65 - 90 years of age 2)Meet definition for MCI including complaints of cognitive decline as indicated by patient report and/or informant report, and corroborated by clinician judgment and, the absence of dementia, defined as impairment of memory and at least one other domain of cognitive function.

3)Fluency in English 4)Willing to meet the time commitment of the study

-

Exclusion Criteria:

1. Clinically significant cerebrovascular disease
2. Individuals scheduled to begin acetylcholinesterase inhibitor (AChEI) therapy -

Primary outcomes:
measure: The study investigates changes in a neuropsychological assessment battery pre-randomization
measure: and upon the completion of training.
Secondary outcomes:
measure: Early evaluations will be conducted from brain imaging; specifically, date
measure: obtained via positron emission tomography (PET), magnetoencephalography (MEG),
measure: electroencephalography (EEG), and functional magnetic resonance imaging (fMRI)
measure: studies.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Joel Kramer, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mejia AA, Nakamura T, Masatoshi I, Hatazawa J, Masaki M, Watanuki S. Estimation of absorbed doses in humans due to intravenous administration of fluorine-18-fluorodeoxyglucose in PET studies. J Nucl Med. 1991 Apr;32(4):699-706.
citation: Barnes DE, Yaffe K, Belfor N, Jagust WJ, DeCarli C, Reed BR, Kramer JH. Computer-based cognitive training for mild cognitive impairment: results from a pilot randomized, controlled trial. Alzheimer Dis Assoc Disord. 2009 Jul-Sep;23(3):205-10. doi: 10.1097/WAD.0b013e31819c6137.