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The Computerized Functional Skills Assessment and Training Program for Mild Cognitive Impairment

Phase 2
Waitlist Available
Led By Philip Harvey, PhD
Research Sponsored by i-Function, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to read at the 6th grade level (WRAT)
Able to read a computer screen and use a keyboard or mouse
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for 12 weeks of training and 3 months of followup
Awards & highlights

Study Summary

This trial is testing a computer-based program to help people with mild cognitive impairment (MCI) learn skills for everyday living, like managing finances and taking medications.

Eligible Conditions
  • Mild Cognitive Impairment
  • Healthy Aging

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You can read at least as well as a sixth grader.
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You can use a computer and know how to read the screen and use a keyboard or mouse.
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You need to score 26 or higher on a test called MOCA.
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You have someone who is willing and able to provide information about you.
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You or someone close to you have noticed problems with your memory.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~compared at baseline, after 12 weeks of training and 3 months after completion of training
This trial's timeline: 3 weeks for screening, Varies for treatment, and compared at baseline, after 12 weeks of training and 3 months after completion of training for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to completion on each Task of the the CFAST
Secondary outcome measures
EMA measurement of real world activities
Performance on The Virtual Reality Functional Capacity Assessment Task
Performance on the Brief Assessment of Cognition App

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: MCI, Skills training onlyExperimental Treatment1 Intervention
These participants will receive 24 hours of CFSAT training over 12 weeks following the same training protocol as the NC sample.
Group II: MCI, Combined treatmentExperimental Treatment2 Interventions
Participants assigned to this condition will initially train for 3 weeks @ 60 minutes twice per week on CT (Posit Science). Participants will train 90 minutes on Double Decision and 30 minutes on Hawkeye. They can train on Hawkeye in 15- minute increments and intersperse it within the Double Decision training. They will then train CFSAT for 9 weeks at the recommended dosage. Each task will be trained twice before advancing to the next task
Group III: Healthy individuals Skills training onlyActive Control1 Intervention
These participants will receive CFSAT training only (n = 60). They will train for 24 hours over 12 weeks.

Find a Location

Who is running the clinical trial?

i-Function, Inc.Lead Sponsor
Philip Harvey, PhDPrincipal InvestigatorUniversity of Miami/iFunction
1 Previous Clinical Trials
41 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the participant pool for this experiment open to individuals over 75?

"The age bracket for this research includes those over 60 and below 100 years of age."

Answered by AI

How many individuals are currently participating in this trial?

"Affirmative, the clinicaltrials.gov database states that this trial is currently recruiting participants. The initial post was on August 1st 2021 and it has been modified as recently as August 23rd 2021. This medical experiment necessitates 180 patients from 2 research centres."

Answered by AI

Are there any vacancies available for those wishing to partake in the trial?

"According to the clinicaltrials.gov website, this research is currently recruiting participants; it was initially made public on August 1st 2021 and its details were last modified on August 23rd of the same year."

Answered by AI

What criteria must one satisfy to be eligible for this research endeavor?

"Aspiring enrollees in this trial must be aged between 60 and 100, with healthy aging. A total of 180 patients are being accepted for the study."

Answered by AI

What potential risks are associated with the Computerized Functional Skills Assessment and Training Program for patients?

"As this is a Phase 2 trial, with data confirming the safety of The Computerized Functional Skills Assessment and Training Program but no evidence for its effectiveness, we at Power have assigned it a score of 2."

Answered by AI

Who else is applying?

What state do they live in?
New York
Florida
How old are they?
18 - 65
What site did they apply to?
Ifunction at University of Miami
Weill Cornell Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Weill Cornell Medical Center: < 48 hours
Average response time
  • < 2 Days
~50 spots leftby Mar 2025