Memory Aids and Lifestyle Changes for Alzheimer's Disease

(BB2 Trial)

Overseen By Sarah Farias, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Dementia, Parkinson's, Bipolar, others

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

Compensation: Varies

Number of Visits: 17

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether learning memory tricks and making lifestyle changes can help older adults maintain mental sharpness. Participants will join one of two groups: one with structured guidance and a digital app to track progress, and the other with self-guided advice. The study seeks older adults who have noticed recent memory slips but can still manage daily activities independently. As an unphased trial, it offers participants the chance to contribute to important research that could enhance cognitive health strategies for older adults.

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's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's interventions are likely to be safe?

Research shows that both the Structured and Self-Guided activities in this trial are safe for participants. Other studies have found these types of activities to be well-received. Participants in similar programs, such as the U.S. POINTER study, safely experienced improvements in thinking and memory. These activities emphasize lifestyle changes, like exercise and brain games, which are generally safe and beneficial. No serious side effects have been reported in these studies. Participants often find these lifestyle activities easy to follow and helpful for their well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for Alzheimer's disease because they emphasize personalized lifestyle changes and digital support. Unlike standard treatments that often focus on medication, the "Structured Group" uses a digital application on an iPad to help participants track their activities and receive reminders, promoting active engagement in their care. The "Self-Guided Group" provides education on memory strategies and healthy living, allowing participants the freedom to integrate these changes into their lives as they see fit. These approaches aim to empower individuals with Alzheimer's to take an active role in managing their condition, potentially leading to improved outcomes and quality of life.

What evidence suggests that this trial's interventions could be effective for Alzheimer's disease?

Research has shown that digital tools in a structured program can help older adults enhance their thinking and memory. In this trial, participants in the Structured Group will use a digital application with specific behavior targets and receive reminders. Studies have shown that this approach can lead to better memory and thinking skills compared to using the app independently. This structured program provides more support and reminders, helping to maintain improvements over time.

Participants in the Self-Guided Group will use memory aids and make lifestyle changes on their own. Evidence suggests these approaches can help protect against memory loss. However, structured programs usually offer greater benefits. Both methods promote healthy habits, but a structured program tends to deliver more consistent results in boosting memory and thinking skills. ^{1 2 3 4 6}

Who Is on the Research Team?

Sarah Farias, PhD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 65 or older who feel their memory or thinking has declined in the past 1-3 years but are still cognitively normal. They should be less active in healthy lifestyles, open to using digital tools like a calendar, and have their doctor's approval due to the physical exercise involved. People with dementia, severe psychiatric disorders, other neurological conditions affecting cognition, or severe sensory issues can't join.

Inclusion Criteria

I am an older adult with normal thinking abilities but have concerns about my memory.

I am 65 years old or older.

You are not regularly active and do not engage in healthy lifestyle habits.

Exclusion Criteria

Previous participation in a previous version of Brain Boosters, or another study utilizing the Digital Memory Notebook (DMN) application or EMMA

I have been diagnosed with dementia or cognitive impairment.

I have a neurological condition that could affect my thinking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants attend group sessions on memory support strategies and healthy lifestyle activities. The Structured Group uses a digital application for tracking.

6 months

Weekly sessions for 10 weeks, then 1-2 sessions per month for 4 months

Post-Intervention Assessment

Cognitive assessments and questionnaires are completed to measure the impact of the intervention.

Immediately after intervention

1 visit (in-person or virtual)

Follow-up

Participants are monitored for changes in cognitive and physical assessments at 6 and 12 months post-intervention.

12 months

Assessments at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Self-Guided
• Structured Group

Trial Overview The study tests if memory aids and lifestyle activities (exercise, mental stimulation, stress management) improve daily functioning in those at risk for Alzheimer's. Participants will either guide themselves or follow a structured program with an iPad app called EMMA over six months and attend educational sessions.

How Is the Trial Designed?

Group I: Structured Group Active Control 1 Intervention

Subjects in this group will will be provided with specific recommended behavior targets (e.g., like how much exercise you should engage in each week). Participants will also receive an iPad to use throughout the study and follow up period with the digital application installed. Subjects will be asked to use the digital application to record their activity and to receive reminders to complete this information. Two in every three participants will receive the iPad and digital application. Participants in this group will receive training on how to use the digital application. The researchers can install the digital application on the subjects' personal iPad or smartphone if they prefer.

Group II: Self-Guided Group Active Control 1 Intervention

Subjects in this group will be provided education on memory support strategies and healthy lifestyles. Participants will decide how they want to implement this information into their daily lives. The study will also provide information on various commercially available digital and other tools that might help participants implement healthy changes their lives. One in every three participants will be enrolled in this group (selected randomly).

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10740219/

Memory support training and lifestyle modifications to ... Evidence-based interventions to protect against cognitive decline among older adults at risk for Alzheimer's disease and related dementias ...

2. aaic.alz.org aaic.alz.org/releases-2025/us-pointer-study-results-announced.asp

U.S. POINTER Lifestyle Intervention Improved Cognition A structured intervention with more support and accountability showed greater improvement compared to a self-guided intervention. In a large ...

3. natap.org natap.org/2025/IAS/jama_baker_2025_oi_250054_1753719493.76129.pdf

Structured vs Self-Guided Multidomain Lifestyle ... Both interventions encouraged increased physical and cognitive activity, healthy diet, social engagement, and cardiovascular health monitoring, ...

4. aaic.alz.org aaic.alz.org/releases-2025/highlights-aaic-2025.asp

Alzheimer's Research Advances at AAIC 2025 | alz.org A structured intervention with more support and accountability showed greater improvement compared to a self-guided intervention, helping to ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3596462/

Cognitive rehabilitation therapies for Alzheimer's disease We review approaches to cognitive rehabilitation in AD, neuropsychological as well as psychological obstacles to effective treatment in this population.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2274580724004631

Multidomain Interventions to Prevent Cognitive Impairment ... The trial will compare two lifestyle-based interventions (structured vs self-guided lifestyle intervention), which vary in their intensity and structure.