Strategy Training for Mild Cognitive Impairment

(ForAging Trial)

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

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Pregnant, CNS disorder, substance disorder, bipolar, schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Loss of cognitive abilities leading to Alzheimer's disease is progressive and destructive, leaving older adults disabled and unable to recall their past. The number of older adults with Alzheimer's disease is expected to triple by the year 2050, yet little research examines amyloid beta deposition, executive function, and progression of disability. This study will test the influence of a novel and promising non-pharmacological intervention, Strategy Training, on the progression of disability in a sample of 150 older adults with Mild Cognitive Impairment who have the option to complete a Positron Emission Tomography (PET) Imaging with Pittsburgh Compound B (PiB).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

Is strategy training safe for humans?

The research does not mention any safety concerns or adverse effects related to strategy training for mild cognitive impairment, suggesting it is generally safe for humans. ^{1 2 3 4 5}

How does the treatment Strategy Training differ from other treatments for mild cognitive impairment?

Strategy Training, also known as Metacognitive Strategy Training, is unique because it focuses on teaching patients to use specific strategies and metacognitive skills (thinking about one's own thinking) to improve decision-making and executive functions, which are crucial for daily activities. Unlike other treatments, it emphasizes analytical thinking and compensatory techniques to enhance memory and attention, showing improvements that can be maintained over time. ^{1 2 4 6 7}

What data supports the effectiveness of the treatment Strategy Training, Metacognitive Strategy Training for Mild Cognitive Impairment?

Research shows that strategy training can improve memory and executive functions (skills for managing tasks) in older adults with mild cognitive impairment. Studies found that participants who received strategy training had better memory recall and language skills, and reported fewer memory complaints in daily life. ^{2 4 6 7 8}

Who Is on the Research Team?

Juleen Rodakowski, OTD,MS,OTR/L

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You live in your own home or apartment.

I have been diagnosed with Mild Cognitive Impairment.

I struggle with a daily activity.

Exclusion Criteria

You have had problems with drugs or alcohol in the last 5 years.

I have a brain disorder other than mild cognitive impairment.

You are currently pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessments including amyloid-beta deposition and neurocognitive function

1 week

1 visit (in-person)

Strategy Training

Participants engage in 10 sessions over 5 weeks with a trained research interventionist to identify and prioritize activity-based goals

5 weeks

10 visits (in-person)

Short-term Follow-up

Assessment of change in disability and cognitive function at 8 weeks post-intervention

8 weeks

1 visit (in-person)

Long-term Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6 and 12 months post-intervention

12 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Strategy Training

Trial Overview 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.

How Is the Trial Designed?

Group I: Strategy Training Experimental Treatment 1 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 Care Active Control 1 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.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

A novel cognitive training program called multi-strategic metamemory training significantly improved long-term delayed free recall and fluency in 66 older adults with mild cognitive impairment compared to a control group of 47 participants.

Participants in the training group also reported a significant decrease in subjective memory complaints, indicating that the program not only enhanced cognitive performance but also improved their perception of everyday memory function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Improvement in Older Adults with Mild Cognitive Impairment: Evidence from a Multi-Strategic Metamemory Training. Youn, JH., Park, S., Lee, JY., et al.[2020]

The process-based multi-task adaptive cognitive training (P-bM-tACT) program significantly improved executive function and other cognitive domains in older adults with mild cognitive impairment (MCI) over a 10-week period, with effects maintained for 3 months after training.

The program was well-received, demonstrating a high adherence rate of 83.4%, indicating its acceptability as a viable intervention for enhancing cognitive function in the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transferability and sustainability of process-based multi-task adaptive cognitive training in community-dwelling older adults with mild cognitive impairment: a randomized controlled trial. Zhao, X., Ji, C., Zhang, C., et al.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Knowledge and use of memory strategies in amnestic mild cognitive impairment. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Strategy-Based Cognitive Training for Improving Executive Functions in Older Adults: a Systematic Review. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Cognitive Improvement in Older Adults with Mild Cognitive Impairment: Evidence from a Multi-Strategic Metamemory Training. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Cognitive stimulation of executive functions in mild cognitive impairment: specific efficacy and impact in memory. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Transferability and sustainability of process-based multi-task adaptive cognitive training in community-dwelling older adults with mild cognitive impairment: a randomized controlled trial. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Metacognitive Strategy Training Improves Decision-Making Abilities in Amnestic Mild Cognitive Impairment. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Developing a Non-Pharmacological Intervention for Individuals With Mild Cognitive Impairment. [2022]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Effects of Process-Based Cognitive Training on Memory in the Healthy Elderly and Patients with Mild Cognitive Impairment: A Randomized Controlled Trial. [2020]