Brain Health Program for Cognitive Aging

(AgeWISE-AP Trial)

Overseen By Andrew H Nguyen, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Dementia, Brain injury, Substance abuse, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 20 weeks

128 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to learn about the effects of AgeWISE-Action Plan (AgeWISE-AP), a 20-week program designed to provide education and individualized planning with a goal of improving brain health.

Do I need to stop my current medications for the trial?

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

What data supports the effectiveness of the treatment AgeWISE-Action Plan (AgeWISE-AP) for cognitive aging?

The Aging Well through Interaction and Scientific Education (AgeWISE) program, which is similar to AgeWISE-AP, showed positive results in a study where older adults learned about the aging brain and strategies to manage cognitive decline. Additionally, the Aging Mastery Program demonstrated improvements in physical activity and planning for future care, suggesting that structured programs can effectively support successful aging. ^{1 2 3 4 5}

Is the Brain Health Program for Cognitive Aging safe for humans?

The safety of treatments for cognitive aging, like the Brain Health Program, is important, especially for older adults who are more prone to adverse drug reactions (unwanted side effects). While specific safety data for this program isn't available, general research suggests that older adults are at higher risk for side effects due to factors like multiple medications and existing health conditions. It's crucial to monitor and manage these risks carefully. ^{6 7 8 9 10}

How is the AgeWISE-Action Plan treatment different from other treatments for cognitive aging?

The AgeWISE-Action Plan is unique because it focuses on cognitive rehabilitation through education about the aging brain and lifestyle strategies, rather than medication. It is a structured 12-week program that helps older adults learn how to maintain brain health and manage cognitive decline through interactive sessions. ^{1 2 3 11 12}

Research Team

Maureen O'Connor, PsyD

Principal Investigator

VA Bedford HealthCare System, Bedford, MA

Eligibility Criteria

This trial is for veterans over 60 years old who are concerned about brain aging and wish to improve their brain health. They must speak English and not have significant cognitive impairment, dementia, major stroke, brain injury, psychotic disorders like schizophrenia, or active substance abuse.

Inclusion Criteria

English speaking as all intervention materials are written in English

I am a veteran over 60 concerned about my brain aging.

Exclusion Criteria

Active alcohol or substance abuse

Veterans with impairment on a cognitive screening measure, as determined using a MoCA cutoff score for dementia of <24 OR self or other reported diagnosis of a brain disorder affecting cognition such as Alzheimer's disease, Parkinson's disease, other dementia, major stroke, or brain injury or diagnosis of psychotic disorder such as schizophrenia

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the AgeWISE-Action Plan, a 20-week program designed to provide education and individualized planning to improve brain health

20 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of various psychological and cognitive measures

12 months

Treatment Details

Interventions

• AgeWISE-Action Plan (AgeWISE-AP)

Trial Overview The AgeWISE-Action Plan (AgeWISE-AP) program is being tested in this study. It's a 20-week educational course with personalized planning aimed at enhancing cognitive function and overall brain health among older adults.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Receiving intervention - AgeWISE-AP

Group II: Waitlist Control Active Control 1 Intervention

No intervention; will be invited to participate in intervention after completion of study.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

VA Boston Healthcare System

Collaborator

Trials

73

Recruited

971,000+

Findings from Research

The AgeWISE program, a 12-week cognitive rehabilitation initiative for older adults, successfully improved participants' memory contentment and sense of control over their memory, as shown in a study with 49 cognitively intact participants aged 60 and older.

Despite these positive outcomes, the program did not significantly enhance participants' knowledge about memory aging or their use of memory improvement strategies, indicating that while it boosts confidence, it may not change practical memory skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Aging Well through Interaction and Scientific Education (AgeWISE) Program. O'Connor, MK., Kraft, ML., Daley, R., et al.[2019]

The 'Ageing Well' program, which involved dual-tasking activities to improve cognitive skills and mobility, showed significant improvements in cognitive state and functional mobility among 23 older adults aged 60+, with participants walking 12% further in a Six Minute Walk Test post-intervention.

Participants in the intervention group also demonstrated a reduction in Timed Up-and-Go test times, indicating enhanced balance and mobility, while the control group showed no changes, highlighting the program's potential effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ageing well: Pilot evaluation of a dual-task training program in a rural community. Nott, MT., Robson, KM., Murphy, K., et al.[2020]

A psychosocial health training intervention for elderly individuals, consisting of 20 hours of classes over 6 months, led to significant improvements in functional ability as measured by the Direct Assessment of Functional Status.

The study, which included 110 participants, showed that health training can enhance the ability to perform daily activities, indicating its potential effectiveness for promoting successful aging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-training intervention for community-dwelling elderly in the SeniorWISE Study. McDougall, GJ., Becker, H., Acee, TW., et al.[2021]

The integration of the 4Ms framework (What Matters, Medication, Mentation, and Mobility) into the ambulatory clinical pathway at MedStar's Center for Successful Aging led to an increase in the number of patients receiving comprehensive care during new patient visits.

The focus on high-risk medications and deprescribing resulted in positive clinical outcomes, highlighting the effectiveness of person-centered care in improving health for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Interdisciplinary Approach to Implementing the Age-Friendly Health System 4Ms in an Ambulatory Clinical Pathway With a Focus on Medication Safety. Guth, A., Chou, J., Courtin, SO., et al.[2021]

The Aging Mastery Program® (AMP) was tested in ten senior centers and showed statistically significant improvements in physical activity and advanced care planning among older adults.

These results indicate that AMP is an effective, evidence-based intervention that can enhance general health and quality of life for seniors, supporting their active management of aging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Effectiveness of the Aging Mastery Program. Ferretti, L., McCallion, P., McDonald, E., et al.[2023]

In France, 8.6% of hospitalizations for patients over 70 are due to adverse drug events, highlighting the need for improved medication safety in the elderly population.

To enhance drug research and prevent iatrogenic reactions, it is crucial to include more elderly participants in clinical trials and consider their unique health challenges, such as polypharmacy and cognitive impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Drug effects in elderly subjects: from the pharmacologic target to the risk-benefit. Round Table #5 of the 16th National Clinical Pharmacology Workshop]. Lassale, C., Piette, F., Jolliet, P.[2013]

The Med Wise program, designed to improve medication communication skills among older adults, was successfully implemented in 8 Wisconsin counties, reaching 198 participants and showing significant increases in knowledge and self-efficacy regarding medication management.

Three months after the program, participants reported increased interactions with pharmacists, with nearly 30% seeking medication reviews, indicating that the program effectively encouraged older adults to engage more actively in their medication management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Med Wise: A theory-based program to improve older adults' communication with pharmacists about their medicines. Martin, BA., Chewning, BA., Margolis, AR., et al.[2018]

Elderly individuals are at a higher risk for adverse drug reactions due to decreased kidney function and reduced ability to counteract drug effects, which can worsen existing chronic conditions.

While age should not prevent necessary medication, it is crucial to regularly reevaluate drug therapy, simplify dosage schedules, and provide clear instructions to improve adherence and minimize risks, especially from sedative medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Geriatric pharmacology. Pharmacokinetics and pharmacodynamics in the elderly. Problems with geriatric and nootropic drugs]. Turnheim, K.[2013]

The SMART tool is a web-based resource designed to help researchers identify side effects of medications commonly used by older adults, aiding in distinguishing between normal aging effects and medication-related issues.

Researchers can use SMART to access detailed information on cognitive, sensory, and motor side effects of specific medications, allowing for better screening of medication side effect severity in their studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A medication screening tool for cognitive aging researchers. Batsakes, PJ., Hancock, HE., Rogers, WA., et al.[2019]

The elderly population has a high prevalence of adverse drug reactions (ADRs), with a mean rate of 30%, making them particularly vulnerable to medication-related issues.

Dementia significantly increases the risk factors for ADRs, such as polypharmacy and inappropriate prescribing, highlighting the need for tailored recommendations to prevent these reactions in elderly patients, especially those with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Recomendations for the prevention of adverse drug reactions in older adults with dementia]. Gómez-Pavón, J., González García, P., Francés Román, I., et al.[2022]

A 14-week community program in Miyaki Town, Japan, involving strength training, brain function training, and health education led to significant improvements in brain function, physical function, body composition, and LDL cholesterol levels among 34 older residents.

The intervention resulted in highly significant enhancements in brain function (p<0.0001) and physical function (p=0.0037), demonstrating the effectiveness of combined training programs for improving health in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a 14-week community health program of exercise and learning/education in older adults: A single-arm pre-post comparison study. Nose, D., Inoue, H., Imaki, K., et al.[2023]

A new multimodal program called 'brain coach' was developed to support cognitive health in older adults, integrating physical, cognitive, social, mindful, and creative activities, and was tested with 660 participants aged around 71 years.

Participants reported improvements in memory, well-being, and lifestyle habits after engaging with the program for at least 3 months, with positive attitudes towards brain health correlating with these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cross-sectional survey of a public, evidence-based multimodal program for cognitive health in older adults. Studer-Luethi, B., Brasser, M., Lusti, S., et al.[2021]

References

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

The Aging Well through Interaction and Scientific Education (AgeWISE) Program. [2019]

2. Australia pubmed.ncbi.nlm.nih.gov

Ageing well: Pilot evaluation of a dual-task training program in a rural community. [2020]

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

Health-training intervention for community-dwelling elderly in the SeniorWISE Study. [2021]

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

An Interdisciplinary Approach to Implementing the Age-Friendly Health System 4Ms in an Ambulatory Clinical Pathway With a Focus on Medication Safety. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Assessing the Effectiveness of the Aging Mastery Program. [2023]

6. France pubmed.ncbi.nlm.nih.gov

[Drug effects in elderly subjects: from the pharmacologic target to the risk-benefit. Round Table #5 of the 16th National Clinical Pharmacology Workshop]. [2013]

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

Med Wise: A theory-based program to improve older adults' communication with pharmacists about their medicines. [2018]

8. Austria pubmed.ncbi.nlm.nih.gov

[Geriatric pharmacology. Pharmacokinetics and pharmacodynamics in the elderly. Problems with geriatric and nootropic drugs]. [2013]

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

A medication screening tool for cognitive aging researchers. [2019]

10. Spain pubmed.ncbi.nlm.nih.gov

[Recomendations for the prevention of adverse drug reactions in older adults with dementia]. [2022]

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

Effects of a 14-week community health program of exercise and learning/education in older adults: A single-arm pre-post comparison study. [2023]

12. England pubmed.ncbi.nlm.nih.gov

A cross-sectional survey of a public, evidence-based multimodal program for cognitive health in older adults. [2021]