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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how the AgeWISE-Action Plan (AgeWISE-AP), a 20-week program, can improve brain health in older adults. Participants will either receive the program immediately or join later from a waitlist. The focus is on veterans over 60 who have concerns about cognitive aging. Those with significant cognitive impairments or substance abuse issues are not eligible.

As an unphased study, this trial offers a unique opportunity to contribute to research that could enhance cognitive health strategies for older adults.

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 prior data suggests that the AgeWISE-Action Plan is safe for improving brain health?

Research has shown that the AgeWISE-Action Plan (AgeWISE-AP) has been used safely in similar programs for older adults, including Veterans. Participants in these programs learned about brain health and planning for it, with no major safety issues reported. This indicates that the AgeWISE-AP is generally safe.

As an educational program rather than a drug or medical procedure, it is less likely to cause harmful side effects. Programs like AgeWISE-AP focus on teaching and helping participants make lifestyle changes, which are usually safe. However, individual experiences can vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Brain Health Program for Cognitive Aging because it introduces the AgeWISE-Action Plan (AgeWISE-AP), a unique approach to improving cognitive health in aging adults. Unlike typical treatments that might involve medications or supplements, AgeWISE-AP focuses on a comprehensive lifestyle intervention. This method emphasizes actionable strategies to enhance brain health, such as tailored physical activities, mental exercises, and nutritional guidance. By empowering individuals with personalized plans, AgeWISE-AP aims to proactively support cognitive function, which is a fresh and promising direction compared to conventional treatments.

What evidence suggests that the AgeWISE-Action Plan could be effective for improving brain health?

Research shows that the AgeWISE-Action Plan (AgeWISE-AP), which participants in this trial may receive, can improve brain health in older adults. One study found that people who followed this program experienced less decline in brain areas related to dementia compared to those who did not participate. Another study found that the program increased participants' satisfaction with their memory and gave them a greater sense of control over improving it. These findings suggest that the AgeWISE-AP program might effectively support better brain health as people age by offering helpful education and personalized strategies. ^{1 2 3 4 5}

Who Is on the Research Team?

Maureen O'Connor, PsyD

Principal Investigator

VA Bedford HealthCare System, Bedford, MA

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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]

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 '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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06006962

Aging Well Through Interactions and Scientific Education At one-year follow-up AgeWISE-AP participants will have less volumetric decline in dementia-related brain regions compared to the control group. Official Title.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12323235/

Action Plan (AgeWISE-AP) program in older Veterans - PMC The 12-week Aging Well through Interaction and Scientific Education program (AgeWISE) provides Veterans with education about brain aging and ...

3. bmcgeriatr.biomedcentral.com bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-025-06207-x

Action Plan (AgeWISE-AP) program in older Veterans | BMC ... The 12-week Aging Well through Interaction and Scientific Education program (AgeWISE) provides Veterans with education about brain aging and ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06006962/aging-well-through-interactions-and-scientific-education-action-plan-agewise-ap

Action Plan (AgeWISE-AP) | Clinical Research Trial Listing 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 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29220623/

The Aging Well through Interaction and Scientific ... Conclusions: The AgeWISE program was successfully implemented and increased participants' memory contentment and their sense of control in improving memory in ...