Status:
ACTIVE_NOT_RECRUITING
Reducing Risk of Dementia Through Deprescribing
Lead Sponsor:
Indiana University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Dementia
Alzheimer Disease, Late Onset
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
A cluster-randomized controlled trial (RCT) called "Reducing Risk of Dementia through Deprescribing" (R2D2) to evaluate the impact of a deprescribing intervention on important cognitive and safety out...
Detailed Description
The R2D2 study will test whether the adverse cognitive effects of anticholinergic medications are reversible by implementing a pharmacist-based deprescribing intervention for older adults within prima...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Participants:
- Age 65 and older;
- At least one office visit to their primary care physician within the previous 12 months;
- Use of a target anticholinergic medication within the last two weeks OR medical record evidence of exposure to target anticholinergic medications at or above a cognitive risk threshold in the prior 12 months
- Able to communicate in English;
- Access to a telephone
- Exclusion Criteria for Participants:
- Permanent resident of an extended care facility (nursing home)
- Diagnosis of schizophrenia, bipolar disorder, or schizoaffective disorder defined by International Classification of Diseases (ICD) version 9/10 codes
- Diagnosis of Alzheimer's Disease or Related Dementia as determined by (a), (b), or (c) below:
- ICD-9/10 codes, or
- Current use of a medication for Alzheimer's Disease or a Related Dementia, or
- A pattern of responses to the Functional Activities Questionnaire (FAQ) that indicate dementia (i.e., ≥ 3 FAQ items are scored at "requires assistance," or if ≥ 1 FAQ item is scored at "dependent").
Exclusion
Key Trial Info
Start Date :
July 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2026
Estimated Enrollment :
344 Patients enrolled
Trial Details
Trial ID
NCT04270474
Start Date
July 20 2020
End Date
July 30 2026
Last Update
March 14 2025
Active Locations (2)
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1
Indiana University Health
Indianapolis, Indiana, United States, 46202
2
Community Health Network Foundation, Inc.
Indianapolis, Indiana, United States, 46256