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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6, 12, 18, and 24 months

Awards & highlights

R2D2 Trial 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.Check my eligibility

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.See study design

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.

R2D2 Trial 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.

R2D2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6, 12, 18, and 24 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Cognitive Composite Score

Change in Health Utilities Index (HUI)

Change in Patient Reported Outcome Measurement Information System (PROMIS)

R2D2 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

982,959 Total Patients Enrolled

17 Trials studying Dementia

53,381 Patients Enrolled for Dementia

National Institute on Aging (NIA)NIH

1,671 Previous Clinical Trials

28,016,719 Total Patients Enrolled

266 Trials studying Dementia

23,625,016 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are eligible to be recruited for this clinical experiment?

"Yes, clinicaltrials.gov reveals that this medical trial has been actively recruiting since July 20th 2020 and is still accepting patients as of February 23rd 2022. The current goal of the study is to recruit 344 individuals from 2 particular locations."

Answered by AI

Are individuals still being enrolled in this research program?

"According to clinicaltrials.gov, this study is presently enrolling applicable candidates. It was initially posted on July 20th 2020 and the latest update occurred on February 23rd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reducing Risk of Dementia Through Deprescribing

Noll Campbell 2020. "Reducing Risk of Dementia Through Deprescribing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04270474.

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