Memory Training for Mild Cognitive Impairment

Recruiting at 1 trial location

Overseen By Nancy Moore

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Kessler Foundation

Must not be taking: Benzodiazepines, Steroids

Disqualifiers: Stroke, Bipolar, Schizophrenia, others

Trial Summary

What is the purpose of this trial?

The current study is a double-blind, placebo-control randomized clinical trial examining the efficacy of memory retraining in individuals with Mild Cognitive Impairment (MCI). Impairment in higher level cognitive processing, such as new learning and memory, is one of the most common deficits in individuals with MCI and such deficits have been shown to exert significant negative impact on multiple aspects of everyday life, including occupational and social functioning. Despite these findings, few studies have attempted to treat these cognitive deficits in order to improve the everyday functioning of individuals with MCI. Through a small randomized clinical trial, the investigators found that individuals with MCI with documented cognitive impairment show a significant improvement in their memory performance following a treatment protocol designed to facilitate learning. The current proposal will replicate this finding and further evaluate (a) the impact of the treatment on everyday functioning, (b) the long term efficacy of the treatment and (c) the utility of booster sessions in facilitating long-term treatment effects. We will randomly assign older individuals who meet criteria for a diagnosis of amnestic MCI to a memory retraining group or a placebo control group. Both groups will undergo baseline, immediate and long-term follow-up assessment consisting of: (1) a traditional neuropsychological battery, (2) an assessment of global functioning examining the impact of the treatment on daily activities, and (3) functional neuroimaging. This design will allow the investigators to evaluate the efficacy of this particular memory retraining technique in an aMCI population through the assessment of cognitive function via a standard evaluation. In addition, the investigators will be able to draw conclusions regarding the impact of this particular memory remediation program on everyday life from questionnaires completed by the participant and a significant other. Optional enrollment in pre- post neuroimaging will also allow the investigators to look at changes in the brain.

Will I have to stop taking my current medications?

The trial excludes participants who use benzodiazepines and steroids, so you would need to stop taking these medications to participate.

What data supports the effectiveness of the treatment Memory Retraining Exercises for mild cognitive impairment?

Research shows that memory training programs can improve memory and language skills in older adults with mild cognitive impairment, as well as reduce their memory-related complaints in daily life. Studies have found that such interventions can enhance verbal memory, language processing, and everyday functioning. ^{1 2 3 4 5}

Is memory training safe for people with mild cognitive impairment?

The research does not report any safety concerns for memory training in people with mild cognitive impairment, suggesting it is generally safe for use in humans. ^{1 3 5 6 7}

How is the Memory Retraining Exercises treatment different from other treatments for mild cognitive impairment?

Memory Retraining Exercises are unique because they focus on improving memory and cognitive function through specific exercises and strategies, rather than using medication. This approach can enhance verbal memory, language processing, and reduce everyday memory complaints by leveraging the brain's ability to adapt and change, known as neuroplasticity. ^{1 2 3 8 9}

Research Team

Nancy D Chiaravalloti, PhD

Principal Investigator

Kessler Foundation

Eligibility Criteria

This trial is for individuals aged 60 or older who have been diagnosed with amnestic Mild Cognitive Impairment (MCI) and are fluent in English. It's not suitable for those with a history of stroke, neurological injuries/diseases, significant alcohol/drug abuse requiring inpatient treatment, use of benzodiazepines/steroids, or major psychiatric conditions like bipolar disorder or schizophrenia.

Inclusion Criteria

I am 60 years old or older.

read and speak English fluently.

You have been diagnosed with mild memory loss by a medical professional as part of this study.

Exclusion Criteria

I am currently using benzodiazepines or steroids.

I have had a stroke or a neurological condition like MS.

Significant alcohol or drug abuse history (inpatient treatment).

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive memory retraining exercises or placebo memory exercises administered on a laptop computer twice a week for five weeks

5 weeks

10 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at multiple time points

18 months

Assessments at 4 time points: immediately post-treatment, 6 months, and 18 months

Optional Neuroimaging

Optional enrollment in pre- and post-treatment neuroimaging to assess changes in the brain

Treatment Details

Interventions

• Memory Retraining Exercises (Behavioural Intervention)
• Placebo Control Memory Exercises (Behavioural Intervention)

Trial Overview The study tests the effectiveness of memory retraining exercises compared to placebo control exercises on improving learning and memory in people with MCI. Participants will be randomly assigned to one of the two groups and assessed through neuropsychological tests, daily functioning questionnaires, and optional functional neuroimaging before and after treatment.

Participant Groups

Group I: Experimental Group Experimental Treatment 1 Intervention

The experimental group will receive memory retraining exercises administered on a laptop computer twice a week for five weeks (10 training sessions).

Group II: Placebo Control Group Placebo Group 1 Intervention

The placebo control group will receive placebo memory exercises administered on a laptop computer twice a week for five weeks (10 placebo control sessions).

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Michigan State University

Collaborator

Trials

202

Recruited

687,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Findings from Research

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]

A review of 226 studies on memory interventions for mild cognitive impairment (MCI) found that only ten met the inclusion criteria, highlighting a lack of robust evidence for the effectiveness of these interventions.

While there is some indication that individuals with MCI can learn specific information and develop compensatory strategies for memory difficulties, the overall methodological quality of the studies was poor, suggesting a need for more rigorous research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the effectiveness of memory interventions in mild cognitive impairment (MCI). Stott, J., Spector, A.[2022]

The study involved 66 older adults with mild cognitive impairment (MCI) who participated in a virtual interactive working memory training (VIMT) program, showing a significant improvement in working memory compared to an active control group after 36 training sessions.

The VIMT program not only helped maintain working memory but also potentially reduced cognitive decline in older adults with MCI, indicating its efficacy as an intervention for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and effectiveness of virtual interactive working memory training for older people with mild cognitive impairment: a single-blind randomised controlled trial. Yang, HL., Chu, H., Kao, CC., et al.[2020]

The Memory Support System (MSS) was successfully learned and utilized by 20 participants with amnestic mild cognitive impairment (MCI), with 95% compliance at the end of training and 89% at follow-up.

Participants showed a medium effect size in improved functional ability, along with reported benefits in independence, self-confidence, and mood, indicating that the MSS may effectively help manage memory loss symptoms in MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A behavioral rehabilitation intervention for amnestic mild cognitive impairment. Greenaway, MC., Hanna, SM., Lepore, SW., et al.[2022]

A cognitive intervention for 52 older adults with amnestic mild cognitive impairment led to significant improvements in everyday memory performance, particularly in prospective memory tasks, after just 2 weeks.

Participants also showed increased knowledge and use of memory strategies following the intervention, suggesting that early cognitive rehabilitation can help manage memory difficulties effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early intervention for mild cognitive impairment: a randomised controlled trial. Kinsella, GJ., Mullaly, E., Rand, E., et al.[2022]

The MEMO+ study is a randomized controlled trial involving 162 participants with mild cognitive impairment (MCI) to evaluate the efficacy of cognitive training and psychosocial interventions over an eight-week period.

The study aims to measure both immediate and long-term effects on cognitive function and daily living skills, potentially leading to improved well-being for individuals with MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring the impact of cognitive and psychosocial interventions in persons with mild cognitive impairment with a randomized single-blind controlled trial: rationale and design of the MEMO+ study. Bier, N., Grenier, S., Brodeur, C., et al.[2022]

Elderly individuals seeking memory training reported more memory complaints and higher levels of depression and anxiety compared to a matched control group, indicating that emotional factors may influence their perception of memory issues.

Despite having more knowledge about memory strategies, the training group did not perform better on memory tests, suggesting that negative beliefs about their memory abilities could contribute to their complaints rather than actual memory deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The elderly and memory complaints. A study of self-knowledge about memory, depression and memory abilities]. Ponds, RW., Bruning, HA., Jolles, J.[2010]

The RALLI program, designed for individuals with mild cognitive impairment (MCI), significantly increased exercise participation, with 84% of participants exercising at least once a week after 12 weeks, compared to 62% at baseline.

Participants also reported improved physical health and emotional well-being, with a mean increase of 156 minutes of exercise per week and 76% continuing to exercise after 6 months, indicating the program's effectiveness in addressing cognitive challenges related to exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Making physical activity accessible to older adults with memory loss: a feasibility study. Logsdon, RG., McCurry, SM., Pike, KC., et al.[2022]

In a randomized pilot study involving participants with mild cognitive impairment (MCI), cognitive training led to significant improvements in verbal memory and increased activation in the left hippocampus after two months.

The results indicate that the hippocampus in individuals with MCI retains enough neuroplasticity to benefit from cognitive training, as evidenced by improvements in 5 out of 6 participants in the experimental group compared to declines in all participants in the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive training changes hippocampal function in mild cognitive impairment: a pilot study. Rosen, AC., Sugiura, L., Kramer, JH., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

A review of the effectiveness of memory interventions in mild cognitive impairment (MCI). [2022]

3. England pubmed.ncbi.nlm.nih.gov

Development and effectiveness of virtual interactive working memory training for older people with mild cognitive impairment: a single-blind randomised controlled trial. [2020]

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

A behavioral rehabilitation intervention for amnestic mild cognitive impairment. [2022]

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

Early intervention for mild cognitive impairment: a randomised controlled trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Measuring the impact of cognitive and psychosocial interventions in persons with mild cognitive impairment with a randomized single-blind controlled trial: rationale and design of the MEMO+ study. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

[The elderly and memory complaints. A study of self-knowledge about memory, depression and memory abilities]. [2010]

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

Making physical activity accessible to older adults with memory loss: a feasibility study. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Cognitive training changes hippocampal function in mild cognitive impairment: a pilot study. [2022]