Alzheimer DiseaseNCT04121858
Brain Safe: Consumer Intervention to Reduce Exposure to Drugs Linked to Alzheimer's Disease
A study testing Brain Safe App in people with Alzheimer Disease and Dementia, run by Indiana University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease, Dementia
- What is being tested?
- Brain Safe App
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 706 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Oct 2019to 27 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 1 primary care visit at Eskenazi Health or IU Health in past 12 months
- Age ≥ 60 years
- Written informed consent and HIPAA authorization for the release of personal health information.
- English-speaking
- At least one prescription for a strong anticholinergic medication with Anticholinergic Cognitive Burden (ACB) score 2 or 3 in prior 12 months, and currently using it
- Community-dwelling in Central Indiana
Show all 9Show fewer
- Not cognitively impaired
- Not terminally ill
- Not sensory impaired (after correction)
Who cannot join
- Permanent resident of an extended care facility (nursing home); independent or assisted senior care living is allowed if managing own medications.
- Diagnosis of Alzheimer's disease or related dementia (ADRD), determined by International Classification of Diseases (ICD)-9/ICD-10 codes or current use of a medication for ADRD
- Diagnosis of schizophrenia, bipolar disorder, or schizoaffective disorder defined by ICD-9/ICD-10 codes
- Involvement in another clinical trial that would prevent or interfere with study objectives
- Sensory or other impairment prohibiting the use of a mobile touchscreen device or other study activity (after correction)
- Not currently using anticholinergic medication
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University
Indianapolis, Indiana, 46202
IU Health
Indianapolis, Indiana, 46202
About this study
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.
Read the detailed description
This study is a randomized clinical trial (RCT) of the efficacy of a direct-to-consumer intervention called Brain Safe to primarily reduce older adults' exposure to prescription anticholinergics and secondarily improve cognitive function and health-related quality of life. 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.
The primary objective is to test the effect of Brain Safe on anticholinergic exposure at 12 months. We hypothesize that anticholinergic exposure will be lower among those randomized to the Brain Safe intervention compared to those randomized to the attention control app at 12 months. 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 months of prescription data. We will electronically capture prescription data monthly and compute TSDD at baseline, 6, and 12 months.
The secondary objective is to test the effect of Brain Safe on: (a) cognitive function and (b) health-related quality of life at 12 months. We hypothesize older adults randomized to Brain Safe will have higher (a) cognitive function, measured by using an objective, performance-based composite, and (b) health-related quality of life (HRQOL), compared to those randomized to the attention control app, at 12 months.
Exploratory objectives are to test the effect of Brain Safe on anticholinergic exposure, cognitive function, and HRQOL at 6 months. This aim will explore the presence of early effects of Brain Safe at 6 months.
- Conditions
- Alzheimer Disease, Dementia
- Being tested
- Brain Safe App, Attention Control App
- Keywords
- anticholinergic, cognitive function, brain, aging
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Safe AppOther
The Brain Safe app includes the medication list, a personalized risk calculator, multimedia educational content, and a conversation starter/doctor's report.
Attention Control AppOther
The attention control app, called Med Safe, includes only the medication list feature.
| Study group | Role | What they receive |
|---|---|---|
| Brain Safe App | Experimental | 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. Receives: Other: Brain Safe App |
| Attention Control App | Sham comparator | 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. Receives: Other: Attention Control App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Standardized Daily Dose (TSDD) - From Medical Records
To calculate the Total Standardized Daily Dose (TSDD), we first calculated the Standardized Daily Dose (SDD) for each anticholinergic medication with an ACB Score of 2 or 3. SDD was calculated by multiplying the strength by the units per dose and frequency per day and number of refills. The product was divided by the minimum effective daily dose (where available) or the minimum effective geriatric dose to standardize the quantity across multiple classes of medications. The SDD for all anticholinergics with an ACB score 2 or 3 was then summed for each participant for each 6-month period, and divided by the number of days in the relevant six month period to arrive at a TSDD.
Range: The minimum possible value is 0 (optimal outcome; indicating zero exposure to ACB 2 or 3 medications). There is no fixed theoretical maximum score(higher value more exposure), as the upper limit is mathematically determined by the total volume and combination of medications a participant is prescribed.
Measured: Baseline, 6 months, 12 Months
Log Transformed Total Standardized Daily Dose (TSDD) - From Medical Records
Construct: Measures natural log-transformed average daily exposure to medications with an Anticholinergic Cognitive Burden (ACB) score of 2 or 3 to normalize data distribution.How Computed: Medication Standardized Daily Dose (SDD) = (strength × units/dose × frequency/day × refills) / minimum effective daily or geriatric dose. The SDD for all eligible drugs is summed over 6 months, divided by the number of days in that period to find raw TSDD, and natural log-transformed ($\ln(x+1)$ or similar) for the final score.Scale Range: Minimum value is 0 (representing 0 raw TSDD, or zero exposure). There is no fixed theoretical maximum, as it is mathematically determined by the volume of medications prescribed.Interpretation: A value of 0 is the optimal outcome (no exposure). Higher values represent greater exposure (worse outcome).
Measured: Baseline, 6, and 12 Months
Secondary outcomes (8)
Overall Cognitive Score
An overall cognitive score evaluating three domains: memory/new learning, executive function, and processing speed. Calculated by taking the mean of standardized Z-scores from the following specific tests: Hopkins Verbal Learning Test-Revised (HVLT-R) total and delayed recall; Trail Making Test Parts A and B; Phonetic Fluency; Semantic Fluency (adjusted); and Symbol Digit Modalities Test (correct).
A Z-score of 0 represents the baseline study population mean.
Standardized scores theoretically range from -3.0 to +3.0. Higher positive Z-scores (standard deviations above the mean) represent better cognitive performance (better outcome). Lower negative Z-scores represent worse cognitive performance (worse outcome). No clinical threshold is defined. Z-scores were derived using baseline means, with timed tests (e.g., Trails) inverted prior to averaging so higher always means better performance.
Measured: Baseline, 6 months, and 12 months
Choice Reaction Time (CRT)
Computer-based assessment of Choice Reaction Time (CRT). It is used to evaluate executive function, attention, and psychomotor speed by measuring the time elapsed between the presentation of one of multiple possible stimuli and the participant's correct response.
The final score represents the average response time (in milliseconds/seconds) across all valid test trials.
The minimum value is 0. There is no fixed theoretical maximum, as the upper limit is bounded only by the participant's maximum delay.
Lower values represent faster reaction times, indicating better executive functioning and psychomotor speed (a better outcome). Higher values indicate slower reaction times (a worse outcome).
Measured: Baseline
Health Utilities Index (HUI) Mark 3
The Health Utilities Index Mark 3 (HUI3) is a self-reported, multi-attribute health status classification system used to measure overall health-related quality of life and functional capacity.
The score is calculated using responses across eight dimensions of health (vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain). These subscales are combined using a mathematically weighted scoring algorithm to compute a single total utility index score.
The total utility score ranges from a minimum of -0.36 (representing a health state considered worse than death) to a maximum of 1.00 (representing perfect health). A score of 0.00 represents death.
Higher values represent a better health-related quality of life (a better outcome). Lower values represent worse health status (a worse outcome).
Measured: Baseline, 6 months, and 12 months
Hopkins Verbal Learning Test (HVLT) Total Recall
Hopkins Verbal Learning Test (HVLT) Total Recall. It is a paper-based list learning and recall assessment used to evaluate verbal memory and new learning capacity.
Participants are read a list of 12 words and asked to freely recall as many as possible across three consecutive learning trials. The total recall score is calculated by summing the number of correctly recalled words across all three trials.
The total recall score ranges from a minimum of 0 to a maximum of 36.
Higher values represent a greater number of words correctly recalled, indicating better memory and verbal learning function (a better outcome). Lower scores indicate worse memory function (a worse outcome).
Measured: Baseline, 6 months, and 12 months
Hopkins Verbal Learning Test (HVLT) Delayed Recall
Hopkins Verbal Learning Test (HVLT) Delayed Recall. It is a paper-based assessment used to evaluate delayed verbal memory retention and recall capacity.
After a standard delay interval (typically 20 to 25 minutes) following the initial learning trials, participants are asked to freely recall the original list of 12 words. The delayed recall score is the total number of words correctly recalled from memory.
The score ranges from a minimum of 0 to a maximum of 12.
Higher values represent a greater number of words retained and recalled after the delay, indicating better memory retention (a better outcome). Lower scores indicate worse memory retention (a worse outcome).
Measured: Baseline, 6 months, 12 months
Trail Making Test (TMT) Parts A
Number Correct Line Segments. This is a performance-based metric derived from the Trail Making Test (TMT) used to assess visual search, scanning, processing speed, and executive function, particularly when a participant is unable to complete the full timed test.
The score is calculated by counting the total number of correct line segments a participant successfully draws connecting the sequences of encircled numbers (or numbers and letters) within the allotted test parameters.
The score ranges from a minimum of 0 to a maximum of 25.
Higher values represent a greater number of correctly drawn segments, indicating better cognitive processing speed and executive functioning (a better outcome). Lower values indicate worse cognitive performance (a worse outcome).
Measured: Baseline, 6 months, and 12 months
Trail Making Test (TMT) Parts B
Number Correct Line Segments (TMT Part B). This is a performance-based metric derived from the Trail Making Test Part B used to assess executive function, cognitive flexibility, and visual-motor tracking. It is particularly useful for quantifying performance when a participant is unable to complete the full timed test.
The score is calculated by counting the total number of correct line segments a participant successfully draws connecting the 25 encircled numbers and letters in an alternating sequence (1, A, 2, B, 3, C...) within the allotted test parameters.
The score ranges from a minimum of 0 to a maximum of 25.
Higher values represent a greater number of correctly drawn segments, indicating better cognitive flexibility and executive functioning (a better outcome). Lower values indicate worse cognitive performance (a worse outcome).
Measured: Baseline, 6 months, and 12 months
Digit-Symbol Substitution Test (DSST) Number of Correct Responses
Digit-Symbol Substitution Test (DSST), utilizing the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding subtest. It is a paper-based assessment used to evaluate processing speed, visual-motor coordination, and sustained attention.
Participants are provided a key pairing numbers (1 through 9) with simple geometric symbols. They are given a strict time limit (120 seconds) to draw the correct corresponding symbols beneath a series of randomized numbers. The final score is the total number of correctly drawn symbols within the time limit.
The score ranges from a minimum of 0 to a maximum of 135 (the maximum possible items on the WAIS-IV Coding form).
Higher values represent a greater number of correctly matched symbols, indicating faster processing speed and better cognitive performance (a better outcome). Lower scores indicate slower processing speed (a worse outcome).
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start16 Oct 2019
- Primary completion27 Feb 2025
- Study completion27 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 706 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Richard Holden, Indiana University
- Investigators
- Richard J Holden, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121858
- Sponsor's protocol ID
- 1811254189
- Other IDs
- R01AG056926
- Status last verified
- May 2026
- First submitted
- 2 Oct 2019
- Last updated
- 20 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers
Publications
Abebe E, Campbell NL, Clark DO, Tu W, Hill JR, Harrington AB, O'Neal G, Trowbridge KS, Vallejo C, Yang Z, Bo N, Knight A, Alamer KA, Carter A, Valenzuela R, Adeoye P, Boustani MA, Holden RJ. Reducing anticholinergic medication exposure among older adults using consumer technology: Protocol for a randomized clinical trial. Res Social Adm Pharm. 2021 May;17(5):986-992. doi: 10.1016/j.sapharm.2020.10.010. Epub 2020 Oct 22.
PubMed 33773639Hill JR, Harrington AB, Adeoye P, Campbell NL, Holden RJ. Going Remote-Demonstration and Evaluation of Remote Technology Delivery and Usability Assessment With Older Adults: Survey Study. JMIR Mhealth Uhealth. 2021 Mar 4;9(3):e26702. doi: 10.2196/26702.
PubMed 33606655
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Safe: Consumer Intervention to Reduce Exposure to Drugs Linked to Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04121858
- Acronym / sponsor ID
- 1811254189
- Conditions
- Alzheimer Disease, Dementia
- Keywords
- anticholinergic, cognitive function, brain, aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 706 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Posted 20 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a randomized clinical trial (RCT) of the efficacy of a direct-to-consumer intervention called Brain Safe to primarily reduce older adults' exposure to prescription anticholinergics and secondarily improve cognitive function and health-related quality of life. 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.
The primary objective is to test the effect of Brain Safe on anticholinergic exposure at 12 months. We hypothesize that anticholinergic exposure will be lower among those randomized to the Brain Safe intervention compared to those randomized to the attention control app at 12 months. 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 months of prescription data. We will electronically capture prescription data monthly and compute TSDD at baseline, 6, and 12 months.
The secondary objective is to test the effect of Brain Safe on: (a) cognitive function and (b) health-related quality of life at 12 months. We hypothesize older adults randomized to Brain Safe will have higher (a) cognitive function, measured by using an objective, performance-based composite, and (b) health-related quality of life (HRQOL), compared to those randomized to the attention control app, at 12 months.
Exploratory objectives are to test the effect of Brain Safe on anticholinergic exposure, cognitive function, and HRQOL at 6 months. This aim will explore the presence of early effects of Brain Safe at 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Brain Safe App | Experimental | Other: Brain Safe App1)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. |
| Attention Control App | Sham comparator | Other: Attention Control App1) 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 may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥ 1 primary care visit at Eskenazi Health or IU Health in past 12 months
- Age ≥ 60 years
- Written informed consent and HIPAA authorization for the release of personal health information.
- English-speaking
- At least one prescription for a strong anticholinergic medication with Anticholinergic Cognitive Burden (ACB) score 2 or 3 in prior 12 months, and currently using it
Key exclusion criteria (6 listed)
- Permanent resident of an extended care facility (nursing home); independent or assisted senior care living is allowed if managing own medications.
- Diagnosis of Alzheimer's disease or related dementia (ADRD), determined by International Classification of Diseases (ICD)-9/ICD-10 codes or current use of a medication for ADRD
- Diagnosis of schizophrenia, bipolar disorder, or schizoaffective disorder defined by ICD-9/ICD-10 codes
- Involvement in another clinical trial that would prevent or interfere with study objectives
- Sensory or other impairment prohibiting the use of a mobile touchscreen device or other study activity (after correction)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain Safe AppThe Brain Safe app includes the medication list, a personalized risk calculator, multimedia educational content, and a conversation starter/doctor's report. | Other | Brain Safe App |
| Attention Control AppThe attention control app, called Med Safe, includes only the medication list feature. | Other | Attention Control App |
Primary outcome
Total Standardized Daily Dose (TSDD) - From Medical Records
Time frame: Baseline, 6 months, 12 Months
To calculate the Total Standardized Daily Dose (TSDD), we first calculated the Standardized Daily Dose (SDD) for each anticholinergic medication with an ACB Score of 2 or 3. SDD was calculated by multiplying the strength by the units per dose and frequency per day and number of refills. The product was divided by the minimum effective daily dose (where available) or the minimum effective geriatric dose to standardize the quantity across multiple classes of medications. The SDD for all anticholinergics with an ACB score 2 or 3 was then summed for each participant for each 6-month period, and divided by the number of days in the relevant six month period to arrive at a TSDD. Range: The minimum possible value is 0 (optimal outcome; indicating zero exposure to ACB 2 or 3 medications). There is no fixed theoretical maximum score(higher value more exposure), as the upper limit is mathematically determined by the total volume and combination of medications a participant is prescribed.
Log Transformed Total Standardized Daily Dose (TSDD) - From Medical Records
Time frame: Baseline, 6, and 12 Months
Construct: Measures natural log-transformed average daily exposure to medications with an Anticholinergic Cognitive Burden (ACB) score of 2 or 3 to normalize data distribution.How Computed: Medication Standardized Daily Dose (SDD) = (strength × units/dose × frequency/day × refills) / minimum effective daily or geriatric dose. The SDD for all eligible drugs is summed over 6 months, divided by the number of days in that period to find raw TSDD, and natural log-transformed ($\ln(x+1)$ or similar) for the final score.Scale Range: Minimum value is 0 (representing 0 raw TSDD, or zero exposure). There is no fixed theoretical maximum, as it is mathematically determined by the volume of medications prescribed.Interpretation: A value of 0 is the optimal outcome (no exposure). Higher values represent greater exposure (worse outcome).
8 secondary outcomes
Overall Cognitive Score
Time frame: Baseline, 6 months, and 12 months
Choice Reaction Time (CRT)
Time frame: Baseline
Health Utilities Index (HUI) Mark 3
Time frame: Baseline, 6 months, and 12 months
Hopkins Verbal Learning Test (HVLT) Total Recall
Time frame: Baseline, 6 months, and 12 months
Hopkins Verbal Learning Test (HVLT) Delayed Recall
Time frame: Baseline, 6 months, 12 months
Trail Making Test (TMT) Parts A
Time frame: Baseline, 6 months, and 12 months
Trail Making Test (TMT) Parts B
Time frame: Baseline, 6 months, and 12 months
Digit-Symbol Substitution Test (DSST) Number of Correct Responses
Time frame: Baseline, 6 months, and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33773639Abebe E, Campbell NL, Clark DO, Tu W, Hill JR, Harrington AB, O'Neal G, Trowbridge KS, Vallejo C, Yang Z, Bo N, Knight A, Alamer KA, Carter A, Valenzuela R, Adeoye P, Boustani MA, Holden RJ. Reducing anticholinergic medication exposure among older adults using consumer technology: Protocol for a randomized clinical trial. Res Social Adm Pharm. 2021 May;17(5):986-992. doi: 10.1016/j.sapharm.2020.10.010. Epub 2020 Oct 22.
- Derived from this study: PubMed 33606655Hill JR, Harrington AB, Adeoye P, Campbell NL, Holden RJ. Going Remote-Demonstration and Evaluation of Remote Technology Delivery and Usability Assessment With Older Adults: Survey Study. JMIR Mhealth Uhealth. 2021 Mar 4;9(3):e26702. doi: 10.2196/26702.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard J Holden, PhD principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Safe App in people with Alzheimer Disease and Dementia, run by Indiana University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Standardized Daily Dose (TSDD) - From Medical Records (time frame: Baseline, 6 months, 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04121858, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.