- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00319891
Computer-Based Training for Mild Alzheimer's Disease
May 13, 2013 updated by: Posit Science Corporation
Computer-Based Training for Mild Cognitive Impairment and Mild Alzheimer's Disease
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
6
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Francisco, California, United States, 94143
- University of California, San Francisco
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The primary objective of this trial will be to assess the feasibility of using computer-based
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cognitive training in an a population with early Alzheimer's Disease.
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Secondary Outcome Measures
Outcome Measure |
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A standardized set of neuropsychological assessments will be conducted pre- and post-
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compuer-based training.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Joel Kramer, PsyD, University of California, San Francisco
- Principal Investigator: Kristine Yaffe, MD, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2004
Primary Completion (Actual)
October 1, 2006
Study Completion
October 1, 2006
Study Registration Dates
First Submitted
April 27, 2006
First Submitted That Met QC Criteria
April 27, 2006
First Posted (Estimate)
April 27, 2006
Study Record Updates
Last Update Posted (Estimate)
May 15, 2013
Last Update Submitted That Met QC Criteria
May 13, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OUT-109-2005
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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