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Deprescribing for Dementia (R2D2 Trial)

N/A
Recruiting
Led By Noll L Campbell, PharmD, MS
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 65 and older
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
Must not have
Diagnosis of schizophrenia, bipolar disorder, or schizoaffective disorder defined by International Classification of Diseases (ICD) version 9/10 codes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6, 12, 18, and 24 months

Summary

This trial will test whether reducing the number of medications people take will improve cognitive function and safety.

Who is the study for?
This trial is for people aged 65 or older who have seen their primary care doctor in the past year, are currently using certain anticholinergic medications known to affect memory, can speak English, and have a phone. It's not for those living in nursing homes or with schizophrenia, bipolar disorder, Alzheimer's Disease or related dementias.
What is being tested?
The study tests if stopping the use of specific anticholinergic drugs (deprescribing) can improve cognitive function compared to usual care without deprescribing. Participants will be grouped by their healthcare provider and randomly assigned to either continue usual care or start the deprescribing process.
What are the potential side effects?
Potential side effects from deprescribing may include withdrawal symptoms like nausea, sweating, restlessness; changes in blood pressure; confusion; heart rate changes; and possible worsening of conditions previously managed by these medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 65 years old or older.
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I have used specific memory-affecting medications recently or in the past year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with schizophrenia, bipolar disorder, or schizoaffective disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6, 12, 18, and 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6, 12, 18, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Cognitive Composite Score
Change in Health Utilities Index (HUI)
Change in Patient Reported Outcome Measurement Information System (PROMIS)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Intervention (ACT)Experimental Treatment1 Intervention
Pharmacist-based Deprescribing
Group II: Usual Care (UC)Placebo Group1 Intervention
Usual Care

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
1,044 Previous Clinical Trials
1,316,525 Total Patients Enrolled
18 Trials studying Dementia
56,810 Patients Enrolled for Dementia
National Institute on Aging (NIA)NIH
1,802 Previous Clinical Trials
28,193,637 Total Patients Enrolled
296 Trials studying Dementia
23,635,196 Patients Enrolled for Dementia
Noll L Campbell, PharmD, MSPrincipal InvestigatorIndiana University/Purdue University

Media Library

Deprescribing of target anticholinergics (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04270474 — N/A
Dementia Research Study Groups: Active Intervention (ACT), Usual Care (UC)
Dementia Clinical Trial 2023: Deprescribing of target anticholinergics Highlights & Side Effects. Trial Name: NCT04270474 — N/A
Deprescribing of target anticholinergics (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04270474 — N/A
~87 spots leftby Jun 2026
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