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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called Strategy Training (also known as Metacognitive Strategy Training) to help older adults with Mild Cognitive Impairment (MCI) manage daily life more effectively. The goal is to determine if this non-drug method can slow the progression of disabilities that may lead to Alzheimer's disease. Participants will either receive regular care or engage in Strategy Training sessions to set and work towards personal goals. Ideal candidates are those diagnosed with MCI who live in the community and experience difficulties in daily activities. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance daily living for those with MCI.

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.

What prior data suggests that Strategy Training is safe for older adults with Mild Cognitive Impairment?

Research has shown that strategy training is generally well-received by people with mild cognitive impairment. Studies have found that participants in this training improved their decision-making skills without major negative effects. For instance, one study reported that participants enhanced their decision-making abilities using logical thinking, with no serious side effects.

Another study observed that cognitive training, including strategy training, improved memory and language skills over time. Participants who received the training performed better than those who did not, with no significant negative effects reported. This indicates that the training is safe for people with mild cognitive impairment.

Overall, evidence suggests that strategy training is safe for its intended participants and does not cause harmful side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Strategy Training for mild cognitive impairment because it offers a unique, goal-oriented approach that empowers individuals to actively engage in their cognitive health. Unlike standard treatments that often focus on medication or psychotherapy, Strategy Training involves personalized sessions where participants identify and prioritize activity-based goals. This hands-on, participant-driven method helps individuals maintain or regain their cognitive abilities through practical, everyday activities, potentially leading to better outcomes in their daily lives.

What evidence suggests that Strategy Training is effective for Mild Cognitive Impairment?

Research has shown that Strategy Training, one of the treatments in this trial, can help people with Mild Cognitive Impairment (MCI). Studies have found that this training improves decision-making and helps maintain mental abilities over time. For example, cognitive strategy training has been more effective at improving language skills compared to other groups. One study showed that this training slowed memory loss over five years in people with MCI. These findings suggest that Strategy Training might slow mental decline and help preserve mental abilities. Participants in this trial may receive Strategy Training or be part of the Enhanced Usual Care group, which provides comprehensive support and monitoring. ^{1 2 3 6 7}

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

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10532678/

Metacognitive Strategy Training Improves Decision-Making ... Metacognitive strategy training improves decision-making abilities in Amnestic mild cognitive impairment.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2274580725001517

Comparative efficacy of cognitive training modalities in ... Pairwise meta-analysis revealed that cognitive strategy training demonstrated superior to active control (AC) or passive control (PC) in improving language ...

3. mdpi.com mdpi.com/2227-9032/12/10/1019

The Efficacy of a Metacognitive Training Program in ... The results demonstrated the sustained effects of the MTP in cognitive and metacognitive measures over a period of six months.

4. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/dad2.12626

Five‐year effects of cognitive training in individuals with mild ... Cognitive training reduced the 5-year memory decline of persons with MCI. Cognitive training also reduced decline on the Montreal Cognitive ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04533204?cond=Cognitive%20strategy&viewType=Table&rank=6

Mnemonic Strategy Versus Spaced Retrieval Training in ... This study compared two active cognitive interventions to evaluate whether one improved memory more than the other in patients with mild cognitive impairment.

6. researchgate.net researchgate.net/publication/373756814_Metacognitive_Strategy_Training_Improves_Decision-Making_Abilities_in_Amnestic_Mild_Cognitive_Impairment

(PDF) Metacognitive Strategy Training Improves Decision ... The results showed that the experimental group improved its ability to decide, based on analytical thinking, about economic and healthcare- ...

7. nature.com nature.com/articles/s41746-023-00987-5

Computerized cognitive training for memory functions in ... This meta-analysis evaluated the benefits of computerized cognitive training (CCT) on memory functions in individuals with MCI or dementia.