Computer-Based Therapy for Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

Official title:

Computer-Based Therapy for Mild Cognitive Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00319943
• Other study ID #: OUT-108-2005
• Status: Completed
• Phase: Phase 1
• First received: April 27, 2006
• Last updated: April 27, 2006
• Start date: September 2004
• Est. completion date: July 2006

Study information

• Verified date: April 2006
• Source: Posit Science Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 90 Years

Eligibility

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 -

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Procedure:
• Computer-based training for Mild Cognitive Impairment (MCI)

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
Posit Science Corporation	Stanford University, University of California, Davis, University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The study investigates changes in a neuropsychological assessment battery pre-randomization
Primary	and upon the completion of training.
Secondary	Early evaluations will be conducted from brain imaging; specifically, date
Secondary	obtained via positron emission tomography (PET), magnetoencephalography (MEG),
Secondary	electroencephalography (EEG), and functional magnetic resonance imaging (fMRI)
Secondary	studies.