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Brain Boosters 2 in Persons at Risk for Alzheimer's Disease: a Digital Application Supported Intervention (BB2)

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ClinicalTrials.gov Identifier: NCT05027789
Recruitment Status : Recruiting
First Posted : August 30, 2021
Last Update Posted : January 11, 2022
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment Phase
Memory Disorders Cognitive Impairment Behavioral: Self-Guided Behavioral: Structured Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Masking Description: The outcomes examiner will be blinded to participants' study arm assignment.
Primary Purpose: Prevention
Official Title: Compensation Training and Lifestyle Modifications to Promote Healthy Aging in Persons at Risk for Alzheimer's Disease: a Digital Application Supported Intervention (Brain Boosters 2)
Actual Study Start Date : August 13, 2021
Estimated Primary Completion Date : August 31, 2025
Estimated Study Completion Date : August 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Self-Guided Group
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
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.

Active Comparator: Structured Group
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
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.




Primary Outcome Measures :
  1. Logical Memory [ Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months ]
    A standardized assessment of narrative episodic memory.

  2. Free and Cued Selective Reminding Test (FCRT) [ Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months ]
    A standardized assessment of immediate and delayed memory by using cues or free recall

  3. Digit Span [ Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months ]
    A standardized assessment of attention and working memory by recalling short lists of numbers immediately in either forward or backwards order.

  4. Trail Making [ Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months ]
    A standardized assessment of executive functioning by assessing following order but switching between letters and numbers.

  5. Digit Symbol [ Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months ]
    A standardized assessment of executive functioning by having participants match symbols and letters.

  6. Verbal Fluency [ Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months ]
    A standardized assessment of executive functioning by having participants list as many words they can that start with a specific letter.

  7. Royal Prince Alfred Prospective Memory Test [ Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months ]
    A standardized assessment of prospective memory by asking participants to remind the examiner of a task at different intervals throughout the session.

  8. Everyday Function [ Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months ]
    Evaluates participants everyday cognition through a variety of self-report questions about their daily functioning.


Secondary Outcome Measures :
  1. Coping Self efficacy (CSES) [ Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months ]
    Questionnaire measuring perceived self-efficacy for coping with challenges and threats

  2. Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months ]
    Self-report measure of depression

  3. Perceived Stress Scale (PSS) [ Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months ]
    Self-report measure of stress

  4. Satisfaction with Life [ Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months ]
    Self-report measure of life satisfaction

  5. Purpose in Life [ Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months ]
    Self-report measure of life purpose

  6. Short Physical Performance Battery [ Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months ]
    Measures gait speed, balance and sit to stand

  7. Brief Resiliency Scale (BRS) [ Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months ]
    Self-reported measure of resilience

  8. Patient Reported Outcomes Measurement Information System (PROMIS) General Health and Quality of Life Measure [ Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months ]
    two question scale assessing feelings on general health and quality of life.

  9. Cooperative Study Activities of Daily Living (ADL) Prevention Instrument (ADCS-ADL-PI) [ Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months ]
    questionnaire measuring functional abilities (e.g., managing finances, medication, shopping, laundry)

  10. Everyday Compensation (EComp) [ Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months ]
    Questionnaire measuring the behavioral compensatory strategies in the context of performing tasks like managing finances, medication, shopping, laundry, etc.

  11. Community Healthy Activities Model Program for Seniors (CHAMPS) [ Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months ]
    Questionnaire measuring frequency and duration of various physical activities and cognitively stimulating activity

  12. Positive Affect and Negative Affect Scale (PANAS) [ Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months ]
    Questionnaire measuring of positive and negative affect

  13. The Gratitude Questionnaire - Six Item Form [ Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months ]
    Questionnaire measuring the frequency of feelings of gratitude

  14. Mindfulness Inventory [ Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months ]
    Questionnaire measuring the construct of mindfulness in daily life (e.g. being aware of thoughts and feelings as well as external events).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The target population is cognitively normal older adults with Subjective Cognitive Concerns (SCC). SCC will be operationalized as

    1. 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'
    2. normal cognition on the modified Telephone Interview of Cognitive Status (mTICS)
    3. 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05027789


Contacts
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Contact: Martha Forloines, PhD (916) 734-5223 mrforloines@ucdavis.edu
Contact: Sarah Farias, PhD (916) 734-6442 farias@ucdavis.edu

Locations
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United States, California
University of California, Davis Alzheimer's Disease Center Recruiting
Sacramento, California, United States, 95817
Contact: Martha Forloines, PhD    916-734-5223    mrforloines@ucdavis.edu   
Contact: Sarah Farias, PhD    916-734-6442    farias@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Sarah Farias, PhD University of California, Davis
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT05027789    
Other Study ID Numbers: 1764579
1R01AG066748-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 30, 2021    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Memory Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations