PolypharmacyNCT06335953
ALIGN: Aligning Medications With What Matters Most (Demonstration)
A study testing Pharmacist-led deprescribing intervention in people with Polypharmacy and Alzheimer's Disease and Related Dementias, run by Johns Hopkins University at 1 site in United States.
Trial summary
The goal of this clinical trial is to test the effectiveness of a pharmacist-led, primary care-based de-prescribing intervention for people living with dementia (PLWD) and the person's care partners. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Polypharmacy, Alzheimer's Disease and Related Dementias, Mild Cognitive Impairment
- What is being tested?
- Pharmacist-led deprescribing intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 474 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2024to 18 Oct 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age ≥65 years
- Diagnosis of dementia from International Classification of Diseases (ICD-10) visit codes or from the EHR problem list
- Five or more medications
- Only active patients, defined as having >1 visit to the primary care clinic within the past year will be included
- Care partners:
- Family or other companions >21 years old who regularly help the patient manage medications.
Who cannot join
- As the pragmatic trial will be based on primary care, individuals residing in long-term care facilities or enrolled in hospice will be excluded.
- Participants must hear well enough to communicate by telephone in English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Community Physicians
Baltimore, Maryland, 21209
About this study
Official title: Demonstration of ALIGN: Aligning Medications With What Matters Most
The goal of this clinical trial is to test the effectiveness of a pharmacist-led, primary care-based de-prescribing intervention for people living with dementia (PLWD) and the person's care partners.
The intervention consists of the following strategies: 1) a de-prescribing educational brochure designed to activate the patient and care partner; 2) a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of the person's goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored de-prescribing recommendations designed to be useful and actionable for the PCP.
The investigators will compare the intervention group with the waitlist control group to see if there is a difference in the primary outcome, the proportion of patients who deprescribe at least one medication by 3 months.
Read the detailed description
PLWD have high rates of polypharmacy. This is due to the high degree of comorbid illnesses and challenging behavioral and psychological symptoms such as apathy and agitation. Guidelines written for individual conditions increase polypharmacy and potentially inappropriate medication (PIM) use, in which risks of medications outweigh benefits, or medications may not align with treatment goals. PIM in PLWD include anticholingerics, psychotropics and opioids, which are prescribed to PLWD in rates that far exceed use in the general older adult population, in spite of the association with harms such as falls, negative cognitive effects, cardiac conduction abnormalities, respiratory suppression and death. Polypharmacy and PIM use among PLWD is associated with adverse drug events, emergency department visits, hospitalizations, and treatment burden, suggesting that in some situations, "the cure may have become the disease."
The use of these and other medications requires nuanced decision-making to balance potential benefits and harms for PLWD. In keeping with principles of person-centered care, people should be on the medicines that will help achieve the persons goals, but not medicines that are likely to be harmful or unhelpful.
Deprescribing statins, antihypertensives, and psychotropic medications in older adults has been shown to be safe, and may lead to improved quality of life, reductions in falls, and improvements in cognitive and psychomotor function. Lessons from successful interventions include the need to target primary care clinicians and patients, and to target more than one class of medications. Most deprescribing interventions have occurred in hospitals, long-term care facilities, or home healthcare, not in primary care - typically the first point of contact with the health care system for PLWD. Few deprescribing studies have addressed care partners of PLWD, despite the enormous strain faced due to medication-related tasks and the person's specific informational and decisional needs and conflicts. These are gaps that the proposed research would address.
The investigator's previous research has shown that care partners want primary care providers (PCPs) to discuss medication-related goals of care as dementia progresses, and to acknowledge the tradeoffs implicit in using medications for symptom management in PLWD. But PCPs cite time pressure and lack of guidance of when and how to stop medications for PLWD as barriers to having these conversations. Pharmacists are ideally suited to help address these problems by providing evidence-based, individualized deprescribing recommendations without increasing demands on PCP time.
The clinical trial consists of the following strategies: 1) direct-to-consumer deprescribing educational materials designed to activate the care partner and PLWD; 2) telehealth visit in which a pharmacist discusses benefits and harms of the medications with the patient and care partner in the context of the person's goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations that are actionable for the PCP. Pharmacists will receive a laminated tip sheet and participate in a 20-minute webinar. Decisions about discontinuation or continuation of medications will ultimately be made by the PCP and patient/care partner.
The trial is designed as a cluster-randomized trial with a delayed (waitlist) control where the unit of randomization will be the clinic. The investigators will enroll 280 patients with 140 per group (intervention group and waitlist control group). PLWD may enroll independently or together with a care partner. Care partners are not required to participate but may do so independently or with the PLWD if desired. Each participant will be in the study approximately 3 months (intervention period and additional follow-up).
This protocol employs a pragmatic design. The intervention is delivered by clinical pharmacists who are integrated in primary care clinics or practice through a centralized telemedicine model.
- Being tested
- Pharmacist-led deprescribing intervention
- Keywords
- Deprescribing
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-led deprescribing interventionBehavioural
The intervention consists of the following strategies: 1) Pharmacists will participate in a 20-minute webinar and receive a laminated tip sheet about the study; 2) Eligible patients and their care partners will receive a single deprescribing educational brochure by mail; 3) Patients and their care partners will have a single telemedicine visit in which the pharmacist will perform medication reconciliation and identify potential adverse effects and concerns related to medicines; 4) The pharmacist will send the PCP up to 3 deprescribing recommendations in the EHR using a standardized template; 5) With the PCP's approval, the pharmacist will call the patient or care partner to implement the deprescribing recommendations and document changes in the EHR.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention consists of the following:
1. Mailing a deprescribing educational brochure to PLWD and care partners;
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP. Receives: Behavioral: Pharmacist-led deprescribing intervention |
| Delayed intervention (wait list control) | Active comparator | The intervention consists of the following:
1. Mailing a deprescribing educational brochure to PLWD and care partners;
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP. Receives: Behavioral: Pharmacist-led deprescribing intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients Who Stop One or More Medications - Per Protocol
The primary outcome for the study will be the patients who stop ≥1 medication, assessed at 3 months, analyzed per protocol and reported as count of participants. Discontinuation will be defined as a medication that is listed on the medication list at one time point and not listed at the subsequent time point. Discontinued medications will be measured using data obtained from the Electronic Health Record (EHR).
Measured: 3 months
Patients Who Stop One or More Medications - Intention-to-Treat
The primary outcome for the study will be the patients who stop ≥1 medication, assessed at 3 months, analyzed by intention-to-treat and reported as count of participants. Discontinuation will be defined as a medication that is listed on the medication list at one time point and not listed at the subsequent time point. Discontinued medications will be measured using data obtained from the Electronic Health Record (EHR).
Measured: 3 months
Secondary outcomes (8)
Patients Who Start One or More New Medications - Per Protocol
The secondary outcome of patients who start ≥1 medication will be assessed at 3 months, analyzed per protocol and reported as count of participants. The start of a medication will be defined as a medication that is not listed on the medication list at one time point and listed at the subsequent time point. New medications started will be measured using data obtained from the EHR.
Measured: 3 months
Patients Who Start One or More New Medications - Intention-to-Treat
The secondary outcome of patients who start ≥1 medication will be assessed at 3 months, analyzed by intention-to-treat and reported as count of participants. The start of a medication will be defined as a medication that is not listed on the medication list at one time point and listed at the subsequent time point. New medications started will be measured using data obtained from the EHR.
Measured: 3 months
Patients Who Stop One or More Potentially Inappropriate Medication (PIM) - Per Protocol
The secondary outcome of patients who stop ≥1 potentially inappropriate medication (PIM) will be assessed at 3 months, analyzed per protocol and reported as count of participants. Discontinuation of a PIM will be defined as a PIM that is listed on the medication list at one time point and not listed at the subsequent time point. Discontinued PIM will be measured using data obtained from the EHR.
Measured: 3 months
Patients Who Stop One or More Potentially Inappropriate Medication (PIM) - Intention-to-Treat
The secondary outcome of patients who stop ≥1 potentially inappropriate medication (PIM) will be assessed at 3 months, analyzed by intention-to-treat and reported as count of participants. Discontinuation of a PIM will be defined as a PIM that is listed on the medication list at one time point and not listed at the subsequent time point. Discontinued PIM will be measured using data obtained from the EHR.
Measured: 3 months
Patients Who Start One or More Potentially Inappropriate Medication (PIM) - Per Protocol
The secondary outcome of patients who start ≥1 potentially inappropriate medication (PIM) will be assessed at 3 months, analyzed per protocol and reported as count of participants. The start of a PIM will be defined as a PIM that is not listed on the medication list at one time point and listed at the subsequent time point. Discontinued PIM will be measured using data obtained from the EHR.
Measured: 3 months
Patients Who Start One or More Potentially Inappropriate Medication (PIM) - Intention-to-Treat
The secondary outcome of patients who start ≥1 potentially inappropriate medication (PIM) will be assessed at 3 months, analyzed by intention-to-treat and reported as count of participants. The start of a PIM will be defined as a PIM that is not listed on the medication list at one time point and listed at the subsequent time point. Discontinued PIM will be measured using data obtained from the EHR.
Measured: 3 months
Total Number of Medications - Per Protocol
Total medication count will be measured using data obtained from the EHR, analyzed per protocol and reported as mean and standard deviation.
Measured: 3 months
Total Number of Medications - Intention-to-Treat
Total medication count will be measured using data obtained from the EHR, analyzed by intention-to-treat and reported as mean and standard deviation.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start7 May 2024
- Primary completion16 Sep 2025
- Study completion18 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for PolypharmacyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 474 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Ariel Green, MD, MPH, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335953
- Sponsor's protocol ID
- IRB00418404
- Other IDs
- U54AG063546
- Status last verified
- Jul 2026
- First submitted
- 22 Mar 2024
- Last updated
- 6 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alzheimer's Association. 2015 Alzheimer's disease facts and figures. Alzheimers Dement. 2015 Mar;11(3):332-84. doi: 10.1016/j.jalz.2015.02.003.
PubMed 25984581Davydow DS, Zivin K, Katon WJ, Pontone GM, Chwastiak L, Langa KM, Iwashyna TJ. Neuropsychiatric disorders and potentially preventable hospitalizations in a prospective cohort study of older Americans. J Gen Intern Med. 2014 Oct;29(10):1362-71. doi: 10.1007/s11606-014-2916-8.
PubMed 24939712Boyd CM, Darer J, Boult C, Fried LP, Boult L, Wu AW. Clinical practice guidelines and quality of care for older patients with multiple comorbid diseases: implications for pay for performance. JAMA. 2005 Aug 10;294(6):716-24. doi: 10.1001/jama.294.6.716.
PubMed 16091574Maust DT, Strominger J, Kim HM, Langa KM, Bynum JPW, Chang CH, Kales HC, Zivin K, Solway E, Marcus SC. Prevalence of Central Nervous System-Active Polypharmacy Among Older Adults With Dementia in the US. JAMA. 2021 Mar 9;325(10):952-961. doi: 10.1001/jama.2021.1195.
PubMed 33687462Carnahan RM, Lund BC, Perry PJ, Chrischilles EA. The concurrent use of anticholinergics and cholinesterase inhibitors: rare event or common practice? J Am Geriatr Soc. 2004 Dec;52(12):2082-7. doi: 10.1111/j.1532-5415.2004.52563.x.
PubMed 15571547Hill-Taylor B, Sketris I, Hayden J, Byrne S, O'Sullivan D, Christie R. Application of the STOPP/START criteria: a systematic review of the prevalence of potentially inappropriate prescribing in older adults, and evidence of clinical, humanistic and economic impact. J Clin Pharm Ther. 2013 Oct;38(5):360-72. doi: 10.1111/jcpt.12059. Epub 2013 Apr 2.
PubMed 23550814Castelino RL, Hilmer SN, Bajorek BV, Nishtala P, Chen TF. Drug Burden Index and potentially inappropriate medications in community-dwelling older people: the impact of Home Medicines Review. Drugs Aging. 2010 Feb 1;27(2):135-48. doi: 10.2165/11531560-000000000-00000.
PubMed 20104939Brown JD, Hutchison LC, Li C, Painter JT, Martin BC. Predictive Validity of the Beers and Screening Tool of Older Persons' Potentially Inappropriate Prescriptions (STOPP) Criteria to Detect Adverse Drug Events, Hospitalizations, and Emergency Department Visits in the United States. J Am Geriatr Soc. 2016 Jan;64(1):22-30. doi: 10.1111/jgs.13884.
PubMed 26782849Gray SL, Anderson ML, Dublin S, Hanlon JT, Hubbard R, Walker R, Yu O, Crane PK, Larson EB. Cumulative use of strong anticholinergics and incident dementia: a prospective cohort study. JAMA Intern Med. 2015 Mar;175(3):401-7. doi: 10.1001/jamainternmed.2014.7663.
PubMed 25621434Wimmer BC, Cross AJ, Jokanovic N, Wiese MD, George J, Johnell K, Diug B, Bell JS. Clinical Outcomes Associated with Medication Regimen Complexity in Older People: A Systematic Review. J Am Geriatr Soc. 2017 Apr;65(4):747-753. doi: 10.1111/jgs.14682. Epub 2016 Dec 19.
PubMed 27991653Page AT, Clifford RM, Potter K, Schwartz D, Etherton-Beer CD. The feasibility and effect of deprescribing in older adults on mortality and health: a systematic review and meta-analysis. Br J Clin Pharmacol. 2016 Sep;82(3):583-623. doi: 10.1111/bcp.12975. Epub 2016 Jun 13.
PubMed 27077231Jansen J, Naganathan V, Carter SM, McLachlan AJ, Nickel B, Irwig L, Bonner C, Doust J, Colvin J, Heaney A, Turner R, McCaffery K. Too much medicine in older people? Deprescribing through shared decision making. BMJ. 2016 Jun 3;353:i2893. doi: 10.1136/bmj.i2893. No abstract available.
PubMed 27260319Scott IA, Hilmer SN, Reeve E, Potter K, Le Couteur D, Rigby D, Gnjidic D, Del Mar CB, Roughead EE, Page A, Jansen J, Martin JH. Reducing inappropriate polypharmacy: the process of deprescribing. JAMA Intern Med. 2015 May;175(5):827-34. doi: 10.1001/jamainternmed.2015.0324.
PubMed 25798731Kutner JS, Blatchford PJ, Taylor DH Jr, Ritchie CS, Bull JH, Fairclough DL, Hanson LC, LeBlanc TW, Samsa GP, Wolf S, Aziz NM, Currow DC, Ferrell B, Wagner-Johnston N, Zafar SY, Cleary JF, Dev S, Goode PS, Kamal AH, Kassner C, Kvale EA, McCallum JG, Ogunseitan AB, Pantilat SZ, Portenoy RK, Prince-Paul M, Sloan JA, Swetz KM, Von Gunten CF, Abernethy AP. Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial. JAMA Intern Med. 2015 May;175(5):691-700. doi: 10.1001/jamainternmed.2015.0289.
PubMed 25798575Iyer S, Naganathan V, McLachlan AJ, Le Couteur DG. Medication withdrawal trials in people aged 65 years and older: a systematic review. Drugs Aging. 2008;25(12):1021-31. doi: 10.2165/0002512-200825120-00004.
PubMed 19021301
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration of ALIGN: Aligning Medications With What Matters Most
- ClinicalTrials.gov ID
- NCT06335953
- Acronym / sponsor ID
- IRB00418404
- Keywords
- Deprescribing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 474 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 7 May 2024 (actual)
- Primary completion
- 16 Sep 2025 (actual)
- Study completion
- 18 Oct 2025 (actual)
- First posted
- 28 Mar 2024 (actual)
- Results
- Posted 6 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test the effectiveness of a pharmacist-led, primary care-based de-prescribing intervention for people living with dementia (PLWD) and the person's care partners.
The intervention consists of the following strategies: 1) a de-prescribing educational brochure designed to activate the patient and care partner; 2) a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of the person's goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored de-prescribing recommendations designed to be useful and actionable for the PCP.
The investigators will compare the intervention group with the waitlist control group to see if there is a difference in the primary outcome, the proportion of patients who deprescribe at least one medication by 3 months.
Detailed description
PLWD have high rates of polypharmacy. This is due to the high degree of comorbid illnesses and challenging behavioral and psychological symptoms such as apathy and agitation. Guidelines written for individual conditions increase polypharmacy and potentially inappropriate medication (PIM) use, in which risks of medications outweigh benefits, or medications may not align with treatment goals. PIM in PLWD include anticholingerics, psychotropics and opioids, which are prescribed to PLWD in rates that far exceed use in the general older adult population, in spite of the association with harms such as falls, negative cognitive effects, cardiac conduction abnormalities, respiratory suppression and death. Polypharmacy and PIM use among PLWD is associated with adverse drug events, emergency department visits, hospitalizations, and treatment burden, suggesting that in some situations, "the cure may have become the disease."
The use of these and other medications requires nuanced decision-making to balance potential benefits and harms for PLWD. In keeping with principles of person-centered care, people should be on the medicines that will help achieve the persons goals, but not medicines that are likely to be harmful or unhelpful.
Deprescribing statins, antihypertensives, and psychotropic medications in older adults has been shown to be safe, and may lead to improved quality of life, reductions in falls, and improvements in cognitive and psychomotor function. Lessons from successful interventions include the need to target primary care clinicians and patients, and to target more than one class of medications. Most deprescribing interventions have occurred in hospitals, long-term care facilities, or home healthcare, not in primary care - typically the first point of contact with the health care system for PLWD. Few deprescribing studies have addressed care partners of PLWD, despite the enormous strain faced due to medication-related tasks and the person's specific informational and decisional needs and conflicts. These are gaps that the proposed research would address.
The investigator's previous research has shown that care partners want primary care providers (PCPs) to discuss medication-related goals of care as dementia progresses, and to acknowledge the tradeoffs implicit in using medications for symptom management in PLWD. But PCPs cite time pressure and lack of guidance of when and how to stop medications for PLWD as barriers to having these conversations. Pharmacists are ideally suited to help address these problems by providing evidence-based, individualized deprescribing recommendations without increasing demands on PCP time.
The clinical trial consists of the following strategies: 1) direct-to-consumer deprescribing educational materials designed to activate the care partner and PLWD; 2) telehealth visit in which a pharmacist discusses benefits and harms of the medications with the patient and care partner in the context of the person's goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations that are actionable for the PCP. Pharmacists will receive a laminated tip sheet and participate in a 20-minute webinar. Decisions about discontinuation or continuation of medications will ultimately be made by the PCP and patient/care partner.
The trial is designed as a cluster-randomized trial with a delayed (waitlist) control where the unit of randomization will be the clinic. The investigators will enroll 280 patients with 140 per group (intervention group and waitlist control group). PLWD may enroll independently or together with a care partner. Care partners are not required to participate but may do so independently or with the PLWD if desired. Each participant will be in the study approximately 3 months (intervention period and additional follow-up).
This protocol employs a pragmatic design. The intervention is delivered by clinical pharmacists who are integrated in primary care clinics or practice through a centralized telemedicine model.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Pharmacist-led deprescribing interventionThe intervention consists of the following: 1. Mailing a deprescribing educational brochure to PLWD and care partners; 2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; 3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP. |
| Delayed intervention (wait list control) | Active comparator | Behavioral: Pharmacist-led deprescribing interventionThe intervention consists of the following: 1. Mailing a deprescribing educational brochure to PLWD and care partners; 2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; 3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age ≥65 years
- Diagnosis of dementia from International Classification of Diseases (ICD-10) visit codes or from the EHR problem list
- Five or more medications
- Only active patients, defined as having >1 visit to the primary care clinic within the past year will be included
- Family or other companions >21 years old who regularly help the patient manage medications.
Key exclusion criteria (2 listed)
- As the pragmatic trial will be based on primary care, individuals residing in long-term care facilities or enrolled in hospice will be excluded.
- Participants must hear well enough to communicate by telephone in English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist-led deprescribing interventionThe intervention consists of the following strategies: 1) Pharmacists will participate in a 20-minute webinar and receive a laminated tip sheet about the study; 2) Eligible patients and their care partners will receive a single deprescribing educational brochure by mail; 3) Patients and their care partners will have a single telemedicine visit in which the pharmacist will perform medication reconciliation and identify potential adverse effects and concerns related to medicines; 4) The pharmacist will send the PCP up to 3 deprescribing recommendations in the EHR using a standardized template; 5) With the PCP's approval, the pharmacist will call the patient or care partner to implement the deprescribing recommendations and document changes in the EHR. | Behavioural | Delayed intervention (wait list control), Intervention |
Primary outcome
Patients Who Stop One or More Medications - Per Protocol
Time frame: 3 months
The primary outcome for the study will be the patients who stop ≥1 medication, assessed at 3 months, analyzed per protocol and reported as count of participants. Discontinuation will be defined as a medication that is listed on the medication list at one time point and not listed at the subsequent time point. Discontinued medications will be measured using data obtained from the Electronic Health Record (EHR).
Patients Who Stop One or More Medications - Intention-to-Treat
Time frame: 3 months
The primary outcome for the study will be the patients who stop ≥1 medication, assessed at 3 months, analyzed by intention-to-treat and reported as count of participants. Discontinuation will be defined as a medication that is listed on the medication list at one time point and not listed at the subsequent time point. Discontinued medications will be measured using data obtained from the Electronic Health Record (EHR).
8 secondary outcomes
Patients Who Start One or More New Medications - Per Protocol
Time frame: 3 months
Patients Who Start One or More New Medications - Intention-to-Treat
Time frame: 3 months
Patients Who Stop One or More Potentially Inappropriate Medication (PIM) - Per Protocol
Time frame: 3 months
Patients Who Stop One or More Potentially Inappropriate Medication (PIM) - Intention-to-Treat
Time frame: 3 months
Patients Who Start One or More Potentially Inappropriate Medication (PIM) - Per Protocol
Time frame: 3 months
Patients Who Start One or More Potentially Inappropriate Medication (PIM) - Intention-to-Treat
Time frame: 3 months
Total Number of Medications - Per Protocol
Time frame: 3 months
Total Number of Medications - Intention-to-Treat
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25984581Alzheimer's Association. 2015 Alzheimer's disease facts and figures. Alzheimers Dement. 2015 Mar;11(3):332-84. doi: 10.1016/j.jalz.2015.02.003.
- Background: PubMed 24939712Davydow DS, Zivin K, Katon WJ, Pontone GM, Chwastiak L, Langa KM, Iwashyna TJ. Neuropsychiatric disorders and potentially preventable hospitalizations in a prospective cohort study of older Americans. J Gen Intern Med. 2014 Oct;29(10):1362-71. doi: 10.1007/s11606-014-2916-8.
- Background: PubMed 16091574Boyd CM, Darer J, Boult C, Fried LP, Boult L, Wu AW. Clinical practice guidelines and quality of care for older patients with multiple comorbid diseases: implications for pay for performance. JAMA. 2005 Aug 10;294(6):716-24. doi: 10.1001/jama.294.6.716.
- Background: PubMed 33687462Maust DT, Strominger J, Kim HM, Langa KM, Bynum JPW, Chang CH, Kales HC, Zivin K, Solway E, Marcus SC. Prevalence of Central Nervous System-Active Polypharmacy Among Older Adults With Dementia in the US. JAMA. 2021 Mar 9;325(10):952-961. doi: 10.1001/jama.2021.1195.
- Background: PubMed 15571547Carnahan RM, Lund BC, Perry PJ, Chrischilles EA. The concurrent use of anticholinergics and cholinesterase inhibitors: rare event or common practice? J Am Geriatr Soc. 2004 Dec;52(12):2082-7. doi: 10.1111/j.1532-5415.2004.52563.x.
- Background: PubMed 23550814Hill-Taylor B, Sketris I, Hayden J, Byrne S, O'Sullivan D, Christie R. Application of the STOPP/START criteria: a systematic review of the prevalence of potentially inappropriate prescribing in older adults, and evidence of clinical, humanistic and economic impact. J Clin Pharm Ther. 2013 Oct;38(5):360-72. doi: 10.1111/jcpt.12059. Epub 2013 Apr 2.
- Background: PubMed 20104939Castelino RL, Hilmer SN, Bajorek BV, Nishtala P, Chen TF. Drug Burden Index and potentially inappropriate medications in community-dwelling older people: the impact of Home Medicines Review. Drugs Aging. 2010 Feb 1;27(2):135-48. doi: 10.2165/11531560-000000000-00000.
- Background: PubMed 26782849Brown JD, Hutchison LC, Li C, Painter JT, Martin BC. Predictive Validity of the Beers and Screening Tool of Older Persons' Potentially Inappropriate Prescriptions (STOPP) Criteria to Detect Adverse Drug Events, Hospitalizations, and Emergency Department Visits in the United States. J Am Geriatr Soc. 2016 Jan;64(1):22-30. doi: 10.1111/jgs.13884.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariel Green, MD, MPH, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist-led deprescribing intervention in people with Polypharmacy and Alzheimer's Disease and Related Dementias, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients Who Stop One or More Medications - Per Protocol (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06335953, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.