Brain Safe App for Alzheimer's Disease

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

706 Participants Needed

Trial Summary

What is the purpose of this trial?

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-dwelling older adults who were prescribed one or more strong anticholinergics. Participants will be randomized to use the Brain Safe app or an attention control medication list app for 12 months, with monthly usage reminders.

Research Team

Richard J Holden, PhD

Principal Investigator

Indiana University School of Medicine

Eligibility Criteria

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.

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

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.

Timeline

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

Treatment Details

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.

Participant Groups

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+