Brain Safe App for Alzheimer's Disease

No longer recruiting at 2 trial locations

Overseen By Christian Vallejo, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must be taking: Anticholinergics

Must not be taking: ADRD medications

Disqualifiers: Alzheimer's, Schizophrenia, Bipolar, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an app called Brain Safe, designed to help reduce the use of anticholinergic medications, which can impact memory and thinking. The study targets older adults who have been prescribed and are currently using these medications. Participants will either use the Brain Safe app, which facilitates discussions with doctors about reducing these medications, or a basic app called the Attention Control App that simply lists their medications. Individuals who have had at least one primary care visit in the past year and live independently in Central Indiana might be suitable candidates. As an unphased trial, this study allows participants to contribute to important research that could enhance medication management for older adults.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it focuses on reducing the use of strong anticholinergic medications. You may need to discuss with the trial team about any changes to your medication.

What prior data suggests that the Brain Safe App is safe for use in older adults?

Research has shown that the Brain Safe app helps people reduce their use of certain medications, such as anticholinergics, which might increase the risk of dementia. These medications often treat conditions like depression or Parkinson's disease. The app provides tools for patients to discuss with their doctors how to reduce these medications.

Since the study tests the app's effectiveness, there is no direct information about side effects from using the app itself. However, because this trial involves an app guiding conversations rather than a new drug or medical procedure, there are no known safety concerns. The app primarily supports safer medication use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for Alzheimer's disease that often rely on medications, the Brain Safe App offers a fresh approach by focusing on patient-doctor communication. This app provides conversation starters that help older adults discuss reducing their exposure to prescription anticholinergics with their physicians. Additionally, it includes an anticholinergic risk assessment, empowering patients to make informed decisions about their medication use. Researchers are excited about this innovative method because it targets the reduction of potential medication side effects, which might improve cognitive health in a novel way.

What evidence suggests that the Brain Safe App is effective for reducing anticholinergic exposure in older adults?

Research has shown that the Brain Safe app, available to participants in this trial, can help reduce the use of certain medications linked to Alzheimer's disease. One study found that tools like Brain Safe led to a 52% decrease in the use of these medications. The app encourages users to discuss reducing these drugs with their doctors and provides a risk assessment to help users understand the potential effects of these medications. This approach is promising because it supports patients in managing their medication with their doctor's guidance. Meanwhile, another group in this trial will use the Attention Control App, which provides a medication list but lacks the conversation starters and risk assessment features of the Brain Safe app. ^{1 2 4 6 7}

Who Is on the Research Team?

Richard J Holden, PhD

Principal Investigator

Indiana University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 60 in Central Indiana who are English-speaking, have had a primary care visit within the last year, and are currently prescribed strong anticholinergic medications. They must not be cognitively impaired, terminally ill, or living in extended care facilities. Those with Alzheimer's disease or severe mental health conditions like schizophrenia cannot participate.

Inclusion Criteria

You do not have impaired senses, even with correction like glasses or hearing aids.

English-speaking

I am 60 years old or older.

Exclusion Criteria

I have been diagnosed with Alzheimer's or a similar type of dementia.

You have a condition that makes it difficult for you to use a mobile touchscreen device or participate in the study activities, even with help.

I have been diagnosed with schizophrenia, bipolar disorder, or schizoaffective disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to use the Brain Safe app or an attention control medication list app for 12 months, with monthly usage reminders

12 months

Monthly electronic data capture

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Attention Control App
• Brain Safe App

Trial Overview The study tests if the Brain Safe app can reduce exposure to drugs linked to Alzheimer's when used by older adults taking anticholinergics. Participants will either use this app or a control medication list app for one year with monthly reminders.

How Is the Trial Designed?

Group I: Brain Safe App Experimental Treatment 1 Intervention

1)Brain Safe App provides conversation starters for older adult patients on target anticholinergics. The conversation starters assist the patient to have discussions with their physicians regarding reduction in exposure to prescription anticholinergics. 2) Provides anticholinergic risk assessment.

Group II: Attention Control App Placebo Group 1 Intervention

1\) Attention Control App provides a medication list for older patients to use but lacks the conversation starters for patient to use with there physicians aimed at reduction in exposure to prescription anticholinergics.2) No anticholinergic risk assessment.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04121858

Brain Safe: Consumer Intervention to Reduce Exposure ... This study is an RCT to evaluate the effectiveness of Brain Safe on reducing anticholinergic exposure. Over 42 months, the trial will enroll 700 community ...

2. reporter.nih.gov reporter.nih.gov/project-details/10620847

Brain Safe - NIH RePORTER While successful in reducing the proportion of anticholinergic users by 52%, this and other interventions delivered by a physician or pharmacist are expensive ...

3. regenstrief.org regenstrief.org/projects/brain-safe/

Brain Safe Our primary, powered outcome is the total standard daily dose (TSDD) measure of anticholinergic exposure at 12 months, which is calculated over the preceding 6 ...

4. medicine.iu.edu medicine.iu.edu/news/2019/07/novel-app-designed-to-help-patients-avoid-drugs-linked-to-dementia

Novel app designed to help patients avoid drugs linked to ... The study, called “Brain Safe: Consumer Intervention to Reduce Exposure to Drugs Linked to Alzheimer's Disease,” is a randomized controlled ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551741120311414

Reducing anticholinergic medication exposure among ... We initiated a randomized clinical trial to evaluate the effectiveness of a patient-facing mobile application (Brain Safe app) compared to an attention control ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8007932/

Reducing Anticholinergic Medication Exposure among Older ... The Brain Safe app has four key features to support the overall goal of reducing exposure to potentially harmful anticholinergic medications. ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6593623/

Anticholinergic Drug Exposure and the Risk of Dementia There were statistically significant associations of dementia risk with exposure to anticholinergic antidepressants, antiparkinson drugs, antipsychotic drugs, ...