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NCT04121858
Brain Safe: Consumer Intervention to Reduce Exposure to Drugs Linked to Alzheimer's Disease
NA trial testing Brain Safe App in Alzheimer Disease in 706 participants. Completed in 27 February 2025.
27 February 2025
Quick facts
| Lead sponsor | Indiana University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 706 |
| Start date | 16 October 2019 |
| Primary completion | 27 February 2025 |
| Estimated completion | 27 February 2025 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Brain Safe App
- Attention Control App
Conditions studied
- Alzheimer Disease — all drugs for Alzheimer Disease →
- Dementia — all drugs for Dementia →
Sponsor
Indiana University
Who can join
60 and older, any sex, with Alzheimer Disease or Dementia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Going Remote-Demonstration and Evaluation of Remote Technology Delivery and Usability Assessment With Older Adults: Survey Study.
Hill JR, Harrington AB, Adeoye P, Campbell NL, et al · · 2021 · cited 16× · PMID 33606655 · DOI 10.2196/26702 -
Deprescribing anticholinergics in primary care older adults: Experience from two models and impact on a continuous measure of exposure.
Campbell NL, Pitts C, Corvari C, Kaehr E, et al · · 2022 · cited 7× · PMID 36620097 · DOI 10.1002/jac5.1682 -
Reducing anticholinergic medication exposure among older adults using consumer technology: Protocol for a randomized clinical trial.
Abebe E, Campbell NL, Clark DO, Tu W, et al · · 2021 · cited 4× · PMID 33773639 · DOI 10.1016/j.sapharm.2020.10.010
Verify or expand the search:
- PubMed search for NCT04121858
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04121858 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Indiana University
- Last refreshed: 13 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04121858.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing