NCT00146263

Brief Summary

Background: The aging of the population has lead to a significant increase in the number of older people suffering from cognitive impairment and dementia. The present lack of effective drug therapy for these conditions makes it imperative to investigate other potential therapeutic interventions. Cognitive training has been described as possibly useful in improving cognitive function in elderly subjects with mild impairment and early dementia. However, there have been few well-designed studies to date and the results are equivocal. Most studies have relied on the use of paper-based neuropsychological assessment instruments with limited accuracy and reproducibility. The investigators have developed a validated computerized neuropsychological assessment battery with increased test-retest reliability. The purpose of this study is to assess the efficacy of a computerized training program on cognitive function in older persons with normal cognition, mild cognitive impairment, and early dementia. Description: A randomized prospective AB/BA crossover study. Methods: Eligible males and females aged 60 years and older following initial computerized neuropsychological assessment will be randomized to receive either a 12-session computerized cognitive training program, or no treatment. Repeat neuropsychological assessment will be followed by a 4-week no treatment phase, reassessment and crossover phase.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

February 27, 2020

Status Verified

February 1, 2020

Enrollment Period

2.2 years

First QC Date

September 4, 2005

Last Update Submit

February 24, 2020

Conditions

Keywords

mild cognitive impairmentdementiaAlzheimer's Diseasecognitive training

Outcome Measures

Primary Outcomes (1)

  • Computerized cognitive assessment using the Mindstreams battery

    Changes in cognitive function including memory, executive function, visual spatial and attention.

    12 weeks

Study Arms (2)

Savyon

ACTIVE COMPARATOR

Computerized cognitive training using the Savyon software

Behavioral: Savyon

Control

PLACEBO COMPARATOR

Usual activity

Behavioral: Control

Interventions

SavyonBEHAVIORAL

Computerized cognitive training

Savyon
ControlBEHAVIORAL

Usual activity

Control

Eligibility Criteria

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

You may qualify if:

  • Age: above 60 years old

You may not qualify if:

  • Visual impairment
  • Educational inability to perform training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beersheva Mental Health Center

Beersheva, Israel

Location

MeSH Terms

Conditions

DementiaCognitive DysfunctionAlzheimer Disease

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersCognition DisordersTauopathiesNeurodegenerative Diseases

Study Officials

  • Tzvi Dwolatzky, MD

    Ben-Gurion University of the Negev

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 4, 2005

First Posted

September 7, 2005

Study Start

September 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

February 27, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations