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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00319891
Other study ID # OUT-109-2005
Secondary ID
Status Completed
Phase Phase 1
First received April 27, 2006
Last updated May 13, 2013
Start date September 2004
Est. completion date October 2006

Study information

Verified date May 2013
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 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date October 2006
Est. primary completion date October 2006
Accepts healthy volunteers No
Gender Both
Age group 60 Years to 90 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
Computer-based Cognitive Training


Locations

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

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary objective of this trial will be to assess the feasibility of using computer-based
Primary cognitive training in an a population with early Alzheimer's Disease.
Secondary A standardized set of neuropsychological assessments will be conducted pre- and post-
Secondary compuer-based training.
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