NCT00319891

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2004

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2006

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

May 15, 2013

Status Verified

May 1, 2013

Enrollment Period

2.1 years

First QC Date

April 27, 2006

Last Update Submit

May 13, 2013

Conditions

Alzheimer's Disease

Keywords

Alzheimer'sADMild Cognitive ImpairmentDementiaCognitive remediationcomputer-based training

Outcome Measures

Primary Outcomes (2)

  • 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 (2)

  • A standardized set of neuropsychological assessments will be conducted pre- and post-

  • compuer-based training.

Interventions

Computer-based Cognitive TrainingPROCEDURE

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Alzheimer DiseaseCognitive DysfunctionDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Joel Kramer, PsyD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Kristine Yaffe, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 27, 2006

First Posted

April 27, 2006

Study Start

September 1, 2004

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

May 15, 2013

Record last verified: 2013-05

Locations

US(1)