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

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Mild Cognitive Impairment+1 MoreThe Computerized Functional Skills Assessment and Training Program - Device
Eligibility
60 - 100
All Sexes
What conditions do you have?
Select

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: For 12 weeks of training and 3 months of followup

Month 3
Time to completion on each Task of the the CFAST
Month 3
Performance on The Virtual Reality Functional Capacity Assessment Task
Performance on the Brief Assessment of Cognition App
Month 3
EMA measurement of real world activities

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

Healthy individuals Skills training only
1 of 3
MCI, Combined treatment
1 of 3
MCI, Skills training only
1 of 3

Active Control

Experimental Treatment

180 Total Participants · 3 Treatment Groups

Primary Treatment: The Computerized Functional Skills Assessment and Training Program · No Placebo Group · Phase 2

MCI, Combined treatmentExperimental Group · 2 Interventions: Brain HQ Double Decision, The Computerized Functional Skills Assessment and Training Program · Intervention Types: Device, Device
MCI, Skills training only
Device
Experimental Group · 1 Intervention: The Computerized Functional Skills Assessment and Training Program · Intervention Types: Device
Healthy individuals Skills training only
Device
ActiveComparator Group · 1 Intervention: The Computerized Functional Skills Assessment and Training Program · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: for 12 weeks of training and 3 months of followup

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

Eligibility Criteria

Age 60 - 100 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The person can read at the 6th grade level.
There are two types of people in the world: those who speak English and those who speak Spanish.
Can read a computer screen and use a keyboard or mouse.
The text states that Jak Bondi meets the criteria for the diagnosis of MCI.
You have a high MOCA score.
no cognitive impairment identified on clinical assessment

Who else is applying?

What state do they live in?
Florida50.0%
New York50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Weill Cornell Medical Center100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria50.0%
Met criteria50.0%

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Weill Cornell Medical Center: < 48 hours
Typically responds via
Email100.0%