Computer-Based Training for Mild Alzheimer's Disease
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Computer-based Cognitive Training
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's, AD, Mild Cognitive Impairment, Dementia, Cognitive remediation, computer-based training
Eligibility Criteria
Inclusion Criteria: Fluent in English. Mini-Mental Status Examination (MMSE) score of 22 or higher. Adequate visual capacity. Adequate hearing capacity. Has a caregiver with some computer experience. Willing and able to commit to the time requirement of the entire study. Exclusion Criteria: Clinically significant cerebrovascular disease. Participant is planning to begin acetylcholinesterase inhibitor (AChEI) therapy. Participants with severe tremor. Axis 1 or 2 psychiatric disorders. History of substance abuse. History of head trauma.
Sites / Locations
- University of California, San Francisco
Outcomes
Primary Outcome Measures
The primary objective of this trial will be to assess the feasibility of using computer-based
cognitive training in an a population with early Alzheimer's Disease.
Secondary Outcome Measures
A standardized set of neuropsychological assessments will be conducted pre- and post-
compuer-based training.
Full Information
NCT ID
NCT00319891
First Posted
April 27, 2006
Last Updated
May 13, 2013
Sponsor
Posit Science Corporation
Collaborators
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT00319891
Brief Title
Computer-Based Training for Mild Alzheimer's Disease
Official Title
Computer-Based Training for Mild Cognitive Impairment and Mild Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Posit Science Corporation
Collaborators
University of California, San Francisco
4. Oversight
5. Study Description
Brief Summary
The primary objective of this study is to evaluate the effects of computer-based training program ("HiFi-AD") on the memory and cognitive abilities of individuals diagnosed with mild Alzheimer's Disease (AD).
Detailed Description
The purpose of this study is to determine the extent to which computer-based cognitive remediation improves cognitive functions using standardized neuropsychological assessments relevant to AD; 2) the acceptability and feasibility of using computer-based cognitive remediation in an AD population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's, AD, Mild Cognitive Impairment, Dementia, Cognitive remediation, computer-based training
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Computer-based Cognitive Training
Primary Outcome Measure Information:
Title
The primary objective of this trial will be to assess the feasibility of using computer-based
Title
cognitive training in an a population with early Alzheimer's Disease.
Secondary Outcome Measure Information:
Title
A standardized set of neuropsychological assessments will be conducted pre- and post-
Title
compuer-based training.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Fluent in English.
Mini-Mental Status Examination (MMSE) score of 22 or higher.
Adequate visual capacity.
Adequate hearing capacity.
Has a caregiver with some computer experience.
Willing and able to commit to the time requirement of the entire study.
Exclusion Criteria:
Clinically significant cerebrovascular disease.
Participant is planning to begin acetylcholinesterase inhibitor (AChEI) therapy.
Participants with severe tremor.
Axis 1 or 2 psychiatric disorders.
History of substance abuse.
History of head trauma.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Kramer, PsyD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kristine Yaffe, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Computer-Based Training for Mild Alzheimer's Disease
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