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Memory Aids and Lifestyle Changes for Alzheimer's Disease (BB2 Trial)

N/A
Recruiting
Led By Sarah Farias, PhD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 65 or older
Independent function in daily life
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in assessment scores from baseline to 6-months, 12-months, and 18-months
Awards & highlights

BB2 Trial Summary

This trial is looking at whether teaching people about memory aids and healthy lifestyle changes can help improve their memory and thinking skills. People in the study will attend group sessions where they will learn about memory strategies and lifestyle changes, and those in the Structured Intervention Group will also use an app to track their progress. The study involves 4 different assessment periods over the course of a year.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this intervention involves lifestyle changes and digital applications rather than medication, typical drug side effects aren't expected. However, participants may experience discomfort adjusting to new routines or learning technology.

BB2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 65 years old or older.
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I can take care of my daily needs without help.

BB2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in assessment scores from baseline to 6-months, 12-months, and 18-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in assessment scores from baseline to 6-months, 12-months, and 18-months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Digit Span
Trigger Finger Disorder
Everyday Function
+5 more
Secondary outcome measures
Brief Resiliency Scale (BRS)
Center for Epidemiologic Studies Depression Scale (CES-D)
Community Healthy Activities Model Program for Seniors (CHAMPS)
+11 more

BB2 Trial Design

2Treatment groups
Active Control
Group I: Structured GroupActive Control1 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 GroupActive Control1 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).

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Who is running the clinical trial?

University of California, DavisLead Sponsor
911 Previous Clinical Trials
4,709,294 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,660 Total Patients Enrolled
Sarah Farias, PhDPrincipal InvestigatorUniversity of California, Davis
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Self-Guided Clinical Trial Eligibility Overview. Trial Name: NCT05027789 — N/A
Cognitive Impairment Research Study Groups: Structured Group, Self-Guided Group
Cognitive Impairment Clinical Trial 2023: Self-Guided Highlights & Side Effects. Trial Name: NCT05027789 — N/A
Self-Guided 2023 Treatment Timeline for Medical Study. Trial Name: NCT05027789 — N/A
Cognitive Impairment Patient Testimony for trial: Trial Name: NCT05027789 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary aim of this medical experiment?

"This clinical trial seeks to measure the efficacy of Trail Making tests, with change in assessment scores from baseline tracked over 6-months, 12-months and 18-month periods. Secondary outcomes include evaluating a patient's self reported depression levels via Center for Epidemiologic Studies Depression Scale (CES-D), Positive Affect and Negative Affect Scale (PANAS) evaluations measuring positive and negative affective states respectively, as well as Coping Self Efficacy (CSES) questionnaires gauging confidence in managing challenges or threats."

Answered by AI

Are individuals younger than fifty-five years of age eligible to participate in this experiment?

"This trial is recruiting participants aged 65 to 90. There are 31 trials for younger people and 663 studies specifically tailored toward the elderly population."

Answered by AI

What is the maximum number of enrollees for this clinical trial?

"Indeed, clinicaltrials.gov records detail that the recruitment process of this investigation is currently ongoing. The study was initially made available on August 13th 2021 and has been updated as recently as December 20th 2021. The trial desires to include 225 people between a single medical site."

Answered by AI

Are there any available patient slots for this trial?

"That is correct. Clinicaltrials.gov has the most recent information, which indicates that this clinical trial was initially posted on August 13th 2021 and is actively recruiting participants. This research requires 225 individuals to be recruited at one site."

Answered by AI

Am I eligible to join this experiment?

"This investigation is enrolling 225 seniors aged between 65 and 90 who have reported diminished memory capabilities over the last 1-3 years. Furthermore, applicants must pass a modified Telephone Interview of Cognitive Status (mTICS) with flying colours, demonstrate independence in daily activities, be open to using digital tools such as a digital calendar, not regularly engage in physical exercise habits already and receive approval from their primary care physician due to the intervention's physical exertion component."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
University of California, Davis Alzheimer's Disease Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

What are the methods to increase brain function?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

I have noticed and increase or loss of short term memory in the last three years.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Brain Boosters 2 in Persons at Risk for Alzheimer's Disease: a Digital Application Supported Intervention
2021. "Brain Boosters 2 in Persons at Risk for Alzheimer's Disease: a Digital Application Supported Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05027789.
~75 spots leftby Aug 2025
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