Reducing Risk of Dementia through Deprescribing: Cognitive Outcomes After AntiCholinergic Reduction (R2D2: COACH)

Studying the Effects of Reducing Certain Medications on Memory

M
Malaz Boustani, MD

Primary Investigator

Enrolling By Invitation
65 years or above
All
Phase N/A
2 Locations

Brief description of study

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 outcomes.  This study will evaluate the effects of the use of a program to reduce prescribing of a group of commonly prescribed medications called anticholingerics that may adversely effect cognitive functioning in older adults.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - ResNet data managers will identify physicians from the medical records of Community Health Network, and these participating physicians' patients will be approached for recruitment.' They may be contacted by phone or during clinic visits upon referral from physician.  Physicians agreeing to participate in the study will be randomized to intervention or usual care in random blocks of two or four and stratified by clinic site. Physician randomization status will determine participants’ study groups. Physicians randomized to usual care will not have access to the intervention. Physicians are not the subjects of the study. The subjects are the patients of the physicians. Physicians will not be aware of how or when their patients are being recruited or for what studies they will be offered.

Detailed description of study

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 primary care practices. Two groups will be recruited: providers (physicians and advanced practice providers including nurse practitioners), and patients. Primary care providers of those prescribed eligible anticholinergic medications will be recruited for participation in the study, and their patients who also meet eligible criteria will be subsequently approached and recruited. Participants will be randomized to one of two groups: the deprescribing intervention group or usual care; the intervention group will receive a pharmacist-based deprescribing intervention, while the usual care group will receive care as usually provided by their primary and/or specialty care providers. The intervention and follow-up data collection will occur over 24 months in order to test the long-term impact of the intervention on the planned clinical outcomes. Study outcomes include cognition (primary) and safety (secondary) through validated self-reported scales.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Dementia, Alzheiimer's Disease, ADRD
  • Age: 65 years or above
  • Gender: All

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:
    1. ICD-9/10 codes, or
    2. Current use of a medication for Alzheimer's Disease or a Related Dementia, or
    3. 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").

This study investigates the impact of reducing certain medications on cognitive function in older adults. These medications, known as anticholinergics, are commonly prescribed but may negatively affect thinking and memory. The purpose of this study is to see if stopping or lowering these medications can improve cognitive health in older adults.

Participants will be divided into two study arms. One group will receive a special program led by pharmacists to help reduce their use of anticholinergic medications, while the other group will continue with their usual care. The study will collect information on participants' thinking, memory, and safety over a period of time to understand the effects of the program.

  • Who can participate: People aged 65 and older who have visited their primary care doctor in the last year and have used certain medications that might affect memory can participate. They must speak English and have access to a telephone. People living in nursing homes or those with certain mental health conditions or dementia cannot join.
  • Study details: Participants will either take part in a pharmacist-led program to reduce certain medications or continue their usual care. The study will observe their cognitive health and safety over time to see the effects of the medication changes.
  • Study timelines: The study will last 24 months.
Updated on 09 Mar 2026. Study ID: CTSI-IIR-R2D2, 1706800075
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only