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Strategy Training for Mild Cognitive Impairment (ForAging Trial)

N/A

Waitlist Available

Led By Juleen Rodakowski, OTD,MS,OTR/L

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

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

Must have

Diagnosis of Mild Cognitive Impairment

Be older than 18 years old

Must not have

Central Nervous System disorder (other than MCI)

Severe medical condition that limits engagement in daily activities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to month 12

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new intervention, Strategy Training, to see if it can help prevent the progression of disability in 150 older adults with Mild Cognitive Impairment.

Who is the study for?

This trial is for older adults living in the community who have been diagnosed with Mild Cognitive Impairment (MCI) and are noticing difficulties with daily activities. It's not suitable for those with other central nervous system disorders, substance disorders within the last five years, severe psychiatric conditions like bipolar disorder or schizophrenia, untreated major depression, severe medical conditions limiting daily activity, or if pregnant.

What is being tested?

The study is testing a non-drug intervention called Strategy Training against Enhanced Usual Care to see if it can slow down disability progression in people with MCI. Participants may also undergo PET Imaging using Pittsburgh Compound B to examine brain changes.

What are the potential side effects?

Since this trial involves non-pharmacological interventions such as cognitive strategies rather than medications, side effects are minimal but could include potential discomfort from routine PET imaging procedures.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with Mild Cognitive Impairment.

Exclusion Criteria

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

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I have a brain disorder other than mild cognitive impairment.

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I have a severe medical condition that restricts my daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to month 12 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in disability

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Strategy TrainingExperimental Treatment1 Intervention

In addition to receiving everything in Enhanced Usual Care, participants will engage in 10 sessions over 5 weeks with a trained research interventionist. Participants will describe activities they do, no longer do, or have never done using the cards from the Activity Card Sort as a guide. The therapist will ask the participants to use this information to identify and prioritize activity-based goals to address in the remaining sessions. These sessions will take place in a location of the participant's choice and will last approximately 1 hour.

Group II: Enhanced Usual CareActive Control1 Intervention

Enhanced usual care will allow older adults to interact with services and support. All mental health treatment (e.g., medications that you may be taking) and psychotherapy (e.g. counseling or social services) will be documented and monitored. Furthermore, all participants assigned to Enhanced Usual Care will receive the same assessments as other participants. The close monitoring will track potential changes in symptoms (e.g., depressive symptoms), and participants will be referred to services as appropriate.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Strategy Training

2013

N/A

~180

0 / 3Eligibility criteria met