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Cognitive Training for Mild Cognitive Impairment
N/A
Waitlist Available
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
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 belowSelect...
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:Select...
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
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 moreOther 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 moreTrial 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
Find a Location
Who is running the clinical trial?
University of FloridaOTHER
1,380 Previous Clinical Trials
761,090 Total Patients Enrolled
University of South FloridaLead Sponsor
422 Previous Clinical Trials
187,922 Total Patients Enrolled
University of California, San FranciscoOTHER
2,551 Previous Clinical Trials
15,256,581 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your score on the Geriatric Depression short scale is higher than 5 out of 15. If you have a mood disorder that is controlled with treatment and your score is lower than 6 out of 15, you are not excluded.I am between 55 and 89 years old.I understand and can follow the study's procedures.You cannot have an MRI because you have a pacemaker, metal implants in your body, or feel very scared in small spaces.I can hear normal speech in at least one ear.I have been diagnosed with dementia.I do not have a brain disorder that affects my ability to participate in the study.I will have surgery, chemotherapy, or radiation within the next 6 months.You have experienced changes in your memory and thinking skills, and have been diagnosed with mild cognitive impairment after a thorough evaluation by a team of experts.Criterion: You scored between 18 and 27 on the Montreal Cognitive Assessment.I have had a stroke that left me with major physical or thinking problems.I can see well enough with both eyes, with vision of 20/50 or better.I can use a computer mouse or touch a screen.I have had a serious head injury that still affects my thinking or memory.I will be available for the next six months without a break longer than three weeks.I have had a brain tumor in the past.I have been diagnosed with Parkinson's disease.You have been diagnosed with mild or more severe dementia.I have been diagnosed with multiple sclerosis or ALS.I have been on stable dementia medication for over 30 days.I am willing and able to give my consent for treatment.I have been diagnosed with congestive heart failure.
Research Study Groups:
This trial has the following groups:- Group 1: CTab
- Group 2: CTabc
- Group 3: CTac
- Group 4: CTa
- Group 5: Computerized Cognitive Stimulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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