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Cognitive Training for Mild Cognitive Impairment

N/A

Recruiting

Led By Jerri Edwards, PhD

Research Sponsored by University of South Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

55 to 89 years of age

Ability to understand study procedures and comply with them for the length of the study

Must not have

Dementia diagnosis

Evidence of a non-neurodegenerative neurological disorder that would interfere with the ability to carry out study activities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at follow-up visit between 6 months to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to find the best combination of cognitive training exercises to improve cognitive function in older adults with mild cognitive impairment, and to reduce the risk of dementia.

Who is the study for?

Adults aged 55-89 with mild cognitive impairment (MCI) are eligible for this trial. They must have a certain score on a cognitive assessment, stable medication use, and changes in cognitive function from their baseline. Participants need to be able to see, hear, and use a computer. Those with severe dementia or other major health issues that affect cognition or study participation are excluded.

What is being tested?

The trial is testing different combinations of cognitive training exercises against computerized cognitive stimulation to improve daily living activities and delay the onset of dementia in older adults at risk. It includes neuroimaging and blood biomarker analysis to identify the most effective CT combination.

What are the potential side effects?

Since this trial involves non-invasive interventions like cognitive training exercises and computerized stimulation, side effects may be minimal but could include eye strain, fatigue or frustration due to challenging tasks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 55 and 89 years old.

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I understand and can follow the study's procedures.

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I can hear normal speech in at least one ear.

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I can see well enough with both eyes, with vision of 20/50 or better.

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I can use a computer mouse or touch a screen.

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I am willing and able to give my consent for treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with dementia.

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I do not have a brain disorder that affects my ability to participate in the study.

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I have had a stroke that left me with major physical or thinking problems.

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I have had a serious head injury that still affects my thinking or memory.

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I will be available for the next six months without a break longer than three weeks.

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I have had a brain tumor in the past.

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I have been diagnosed with Parkinson's disease.

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I have been diagnosed with multiple sclerosis or ALS.

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I have been diagnosed with congestive heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at follow-up visit between 6 months to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at follow-up visit between 6 months to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at follow-up visit between 6 months to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dementia incidence

Secondary study objectives

Examiner Executive Function Set shifting, Anti-Saccades, and Flanker performance composite score

Graduated continuous performance test score

Timed IADL performance score

+2 more

Other study objectives

Neuroimaging MRI hippocampal subfield volume from high resolution hippocampal images

Neuroimaging MRI regional and white matter metrics of fractional anisotropy from diffusion weighted imaging

Neuroimaging MRI regional and white matter metrics of median diffusivity from diffusion weighted imaging

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: CTacExperimental Treatment1 Intervention

Participants will complete computerized cognitive training. The duration is 60 min/day; the frequency is two to three days/wk, for 16 weeks with the goal of completing 40 sessions.

Group II: CTabcExperimental Treatment1 Intervention

Participants will complete computerized cognitive training. The duration is 60 min/day; the frequency is two to three days/wk, for 16 weeks with the goal of completing 40 sessions.

Group III: CTabExperimental Treatment1 Intervention

Participants will complete computerized cognitive training. The duration is 60 min/day; the frequency is two to three days/wk, for 16 weeks with the goal of completing 40 sessions.

Group IV: CTaExperimental Treatment1 Intervention

Participants will complete computerized cognitive training. The duration is 60 min/day; the frequency is two to three days/wk, for 16 weeks with the goal of completing 40 sessions.

Group V: Computerized Cognitive StimulationActive Control1 Intervention

Participants will complete cognitively-stimulating computer activities. The duration is 60 min/day; the frequency is two to three days/wk, for 16 weeks with the goal of completing 40 sessions.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Training

2008

Completed Phase 3

~4100

0 / 15Eligibility criteria met