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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at follow-up visit between 6 months to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dementia incidence
Secondary outcome measures
Examiner Executive Function Set shifting, Anti-Saccades, and Flanker performance composite score
Graduated continuous performance test score
Timed IADL performance score
+2 moreOther outcome measures
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
1,341 Previous Clinical Trials
714,362 Total Patients Enrolled
University of South FloridaLead Sponsor
412 Previous Clinical Trials
185,754 Total Patients Enrolled
University of California, San FranciscoOTHER
2,506 Previous Clinical Trials
15,237,250 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: CTabc
- Group 2: CTab
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are elderly patients being enrolled for this research study?
"This study seeks to include aged individuals between 55 and 89 years old."
Answered by AI
Is recruitment ongoing for this clinical trial?
"Data posted on clinicaltrials.gov states that the initial posting date of this medical trial was March 3rd, 2020 and it was last modified in October 5th, 2022. At present time, there are no active recruitment efforts for this study; however, 884 other trials currently require participants."
Answered by AI
Do I fulfill the criteria to participate in this research endeavor?
"This dementia-focused clinical trial is presently open for recruitment, admitting roughly 69 participants aged between 55 and 89 years old."
Answered by AI
Who else is applying?
What site did they apply to?
University of Florida
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I'm so used to losing things, forgetting things, making up to acronyms to remember things only to remember the acromym, but not what the letters stand for, as well as leaving the room for things only to get to the right area and haven forgot what I went looking for. I'm willing to try something. My neurologist is on board with it as well.
PatientReceived 1 prior treatment
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