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

263 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to determine if training in memory support aids and healthy lifestyle activities (physical exercise, mentally stimulating activities and stress management) can have a positive effect on memory, thinking, and activities that people do every day. Participation in this study will involve being placed into one of two groups: a Self-Guided Intervention Group or a Structured Intervention Group. Both groups will be asked to attend group sessions in which they will be provided education on memory support strategies and lifestyle changes. The Structured Intervention Group will also be provided with an iPad and a digital application (called EMMA) to track their activity. Study participation involves a 6-month intervention and completing outcome measures at 4 different time points for up to a year.

Research Team

Sarah Farias, PhD

Principal Investigator

University of California, Davis

Eligibility Criteria

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.

I feel my memory or thinking has worsened in the last 1-3 years more than others my age.

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.

Inability to complete the study protocols due to severe vision or hearing difficulties

Timeline

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

Treatment Details

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.

Participant Groups

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+