Brain Boosters 2 in Persons at Risk for Alzheimer's Disease: a Digital Application Supported Intervention

NCT05027789 | Active Not Recruiting DMC

• 2 other identifiers: 17645791R01AG066748-01A1
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Memory Disorders; Cognitive Impairment

Outcome Measures

Primary Outcomes (8)

• Logical Memory

  A standardized assessment of narrative episodic memory.

  Change in assessment scores from baseline to 6-months, 12-months, and 18-months

• Free and Cued Selective Reminding Test (FCRT)

  A standardized assessment of immediate and delayed memory by using cues or free recall

  Change in assessment scores from baseline to 6-months, 12-months, and 18-months

• Digit Span

  A standardized assessment of attention and working memory by recalling short lists of numbers immediately in either forward or backwards order.

  Change in assessment scores from baseline to 6-months, 12-months, and 18-months

• Trail Making

  A standardized assessment of executive functioning by assessing following order but switching between letters and numbers.

  Change in assessment scores from baseline to 6-months, 12-months, and 18-months

• Digit Symbol

  A standardized assessment of executive functioning by having participants match symbols and letters.

  Change in assessment scores from baseline to 6-months, 12-months, and 18-months

• Verbal Fluency

  A standardized assessment of executive functioning by having participants list as many words they can that start with a specific letter.

  Change in assessment scores from baseline to 6-months, 12-months, and 18-months

• Royal Prince Alfred Prospective Memory Test

  A standardized assessment of prospective memory by asking participants to remind the examiner of a task at different intervals throughout the session.

  Change in assessment scores from baseline to 6-months, 12-months, and 18-months

• Everyday Function

  Evaluates participants everyday cognition through a variety of self-report questions about their daily functioning.

  Change in assessment scores from baseline to 6-months, 12-months, and 18-months

Secondary Outcomes (14)

• Coping Self efficacy (CSES)

  Change in assessment scores from baseline to 6-months, 12-months, and 18-months

• Center for Epidemiologic Studies Depression Scale (CES-D)

  Change in assessment scores from baseline to 6-months, 12-months, and 18-months

• Perceived Stress Scale (PSS)

  Change in assessment scores from baseline to 6-months, 12-months, and 18-months

• Satisfaction with Life

  Change in assessment scores from baseline to 6-months, 12-months, and 18-months

• Purpose in Life

  Change in assessment scores from baseline to 6-months, 12-months, and 18-months

Study Arms (2)

Self-Guided Group

ACTIVE COMPARATOR

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).

Behavioral: Self-Guided

Structured Group

ACTIVE COMPARATOR

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.

Behavioral: Structured Group

Interventions

Self-Guided BEHAVIORAL

People in this arm will come to 15 information sessions. These sessions will provide training and education on memory support strategies and healthy lifestyles. You will decide how you want to implement this information into your daily life.

Self-Guided Group

Structured Group BEHAVIORAL

People in this group will come to 15 information sessions. The study will provide recommended behavior targets (like how much exercise you should have each week). Participants in this group will either receive an iPad or have a special application installed on their own personal device. They will receive training on how to use the application, and will be asked to use the application to record their activities and receive reminders.

Structured Group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• The target population is cognitively normal older adults with Subjective Cognitive Concerns (SCC). SCC will be operationalized as
• a positive complaint in response to the question: 'Have you experienced a decline in your memory or other aspect of thinking in the last 1-3 years that seems worse than others of your age'
• normal cognition on the modified Telephone Interview of Cognitive Status (mTICS)
• independent function in daily life.
• Age 65 or older
• English speaking
• Lower level of engagement in healthy lifestyle behaviors and compensation use at study baseline (i.e., broadly defined as not a regular exerciser)
• Approval from primary care (due to physical exercise component of the intervention)
• Open to utilizing digital tools such as a digital calendar in daily life

You may not qualify if:

• Known diagnosis of dementia or cognitive impairment;
• Other known neurological condition with potential to affect cognition (e.g., Parkinson's disease)
• Reported history of severe psychiatric disorder (e.g., self-reported history of bipolar disorder or schizophrenia or other psychotic disorder)
• Inability to complete the study protocols due to severe vision or hearing difficulties.
• Has previously participated in a previous version of Brain Boosters, or another study utilizing the Digital Memory Notebook (DMN) application or EMMA.

Sponsors & Collaborators

• University of California, Davis: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of California, Davis Alzheimer's Disease Center

Sacramento, California, 95817, United States

Location

Related Publications (1)

• Tomaszewski Farias S, Fox J, Dulaney H, Chan M, Namboodiri S, Harvey DJ, Weakley A, Rahman S, Luna C, Beech BF, Campbell L, Schmitter-Edgecombe M. Memory support training and lifestyle modifications to promote healthy aging in persons at risk for Alzheimer's disease: a digital application supported intervention (Brain Boosters). BMC Geriatr. 2023 Dec 21;23(1):881. doi: 10.1186/s12877-023-04574-x.

  PMID: 38129775 DERIVED

MeSH Terms

Conditions

Memory Disorders; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sarah Farias, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes examiner will be blinded to participants' study arm assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This project will utilize a randomized controlled trial (RCT) design with single blinding (outcomes examiner) comparing the structured intervention (combined structured training in compensation and lifestyle modification, assisted by the EMMA) to the self-guided intervention group, which focuses on providing education and allowing participants to choose how to implement the information was chosen to account for the impact of two general factors: 1) the provision of information, and 2) the social support and stimulation provided by attending a group-based intervention.

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 30, 2021
• Study Start: August 13, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)