Computer-Based Training for Mild Alzheimer's Disease | NCT00319891

Studies
Computer-Based Training for Mild Alzheimer's Disease

NCT00319891

Sponsor

Posit Science Corporation

Status

Completed

Last Update Posted

May 15, 2013Estimated

Enrollment

Phase

Phase 1

Conditions

Alzheimer's Disease

Interventions

Computer-based Cognitive Training

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

Oct 2006Actual

Completion Date

Oct 2006

First Submitted Date

Apr 27, 2006

First Submission Date that Met QC Criteria

Apr 27, 2006

First Posted Date

Apr 27, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2013

Last Update Posted Date

May 15, 2013Estimated

Name	Class
University of California, San Francisco	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Computer-based Cognitive Training	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
A standardized set of neuropsychological assessments will be conducted pre- and post-
compuer-based training.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joel Kramer, PsyD	University of California, San Francisco	Principal Investigator
Kristine Yaffe, MD	University of California, San Francisco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, San Francisco		San Francisco	California	94143	United States

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease
D060825	Cognitive Dysfunction
D003704	Dementia

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D024801	Tauopathies

Browse Leaves

Not provided

Browse Branches

Not provided