Care Delivery Protocol for Alzheimer's Disease

Overseen By Alison O'Donnell, DO, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Pittsburgh Healthcare System

Disqualifiers: None

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help Veterans with early signs of Alzheimer's or similar memory issues access care more effectively. It combines telehealth (virtual doctor visits), advanced tests, and faster processes to determine eligibility for certain Alzheimer's treatments. One group will try this new method, called the ADRD Care Delivery Protocol, while another group will receive usual care. Veterans with mild memory problems who live at home and have a phone might be a good fit for this trial. As an unphased trial, this study offers Veterans a unique opportunity to contribute to innovative care solutions and potentially improve their access to Alzheimer's treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this care delivery protocol is safe for Veterans with Alzheimer's Disease?

Research has shown that the ADRD Care Delivery Protocol aims to improve care for people with Alzheimer's and related disorders. This study uses telehealth and other tools to identify patients who might benefit from specific treatments. Although specific safety data for this protocol is unavailable, the methods used, such as telehealth and cognitive screening, are generally safe.

The study is labeled "Not Applicable" for phase, indicating it likely does not involve new drugs or high-risk procedures. This suggests the protocol focuses on improving care delivery rather than testing a new treatment. The main goal is to safely coordinate and enhance existing care practices.

In summary, there is no evidence of negative effects from the care protocol itself. The methods used are already part of standard healthcare practices and are well-tolerated by most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ADRD Care Delivery Protocol for Alzheimer's Disease because it incorporates telehealth preparedness assessments, cognitive screenings, and blood biomarker testing before consultations with specialists. Unlike the usual care, which relies on the discretion of specialists for evaluations and tests, this protocol offers a structured and proactive approach. This method aims to streamline and personalize patient care, potentially leading to more timely and tailored interventions, which could improve patient outcomes and overall management of Alzheimer's Disease.

What evidence suggests that this care delivery protocol is effective for Alzheimer's Disease?

Research has shown that early detection of Alzheimer's Disease and Related Disorders (ADRD) can greatly improve patient outcomes. One study found a 31% increase in new ADRD diagnoses when clinics used digital tools to identify dementia. This trial will compare the ADRD Care Delivery Protocol—which includes telehealth preparedness assessment, cognitive screening, and blood biomarker testing—with Usual Care, where evaluation and testing are at the specialist's discretion. Advanced technology and telehealth can facilitate earlier disease detection. Guidelines indicate that using these methods generally improves patient outcomes. This approach aims to enhance access to care for Veterans with ADRD by integrating these elements. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for Veterans with mild cognitive impairment or early dementia at VA Pittsburgh. It aims to improve care access for those with Alzheimer's Disease and Related Disorders (ADRD) using a new protocol.

Inclusion Criteria

Enrolled in VA care

Lives in a home setting (i.e., not in an institutional setting such as a nursing home, Community Living Center, or hospital)

Has a working telephone

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Telehealth Preparedness and Cognitive Screening

Participants undergo telehealth preparedness assessment, cognitive screening, and blood biomarker testing

4-6 weeks

2 visits (virtual)

Eligibility Determination

Time from randomization to determination of eligibility for monoclonal antibody therapy

Up to 12 months

Follow-up

Participants are monitored for safety and effectiveness after initial infusion

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ADRD Care Delivery Protocol

Trial Overview The study tests an ADRD Care Delivery Protocol that includes telehealth, advanced diagnostics, and efficient workflows to speed up screening for eligibility for amyloid targeting therapies in Veterans.

How Is the Trial Designed?

Group I: ADRD Care Delivery Protocol Experimental Treatment 1 Intervention

Patients will undergo telehealth preparedness assessment, cognitive screening, and blood biomarker testing prior to the initial consultation with the specialist.

Group II: Usual Care Active Control 1 Intervention

Patients will undergo usual care with all evaluation and testing at the discretion of the specialist.

Who Is Running the Clinical Trial?

VA Pittsburgh Healthcare System

Lead Sponsor

Trials

36

Recruited

15,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11953564/

Primary care preparedness to care for patients with ADRD A total of 1245 of 3498 practices (36%) responded. Most practices reported systems to detect patients with ADRD (67%) and refer patients for ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11837731/

Clinically meaningful outcomes in Alzheimer's disease and ... A workshop exploring clinically meaningful changes in the context of Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD) clinical trials.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2841183

Digital Detection of Dementia in Primary Care Findings This randomized clinical trial including 5325 patients found that the odds of new ADRD diagnoses was 31% higher in the clinics ...

4. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.14333

Alzheimer's Association clinical practice guideline for ... - Wiley If clinicians use this guideline and health-care systems provide adequate resources, outcomes should improve in most patients in most practice ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2274580725001141

Using machine learning and electronic health record (EHR ... Early detection of ADRD can significantly improve patient outcomes through timely treatment.

6. researchprotocols.org researchprotocols.org/2023/1/e45274/

Care Partner Inclusion of People Hospitalized With ... This paper describes the study protocol for the development and refinement of the ADRD Systematic Hospital Inclusion Family Toolkit (A-SHIFT).

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9308637/

A research protocol for user-centered technology to aid ... A research protocol for user-centered technology to aid caregiver management of medications for people with Alzheimer's disease and related dementias.

8. sciencedirect.com sciencedirect.com/org/science/article/pii/S1929074823001567

Care Partner Inclusion of People Hospitalized With ... Introduction. Persons living with Alzheimer disease and related dementias (ADRD) experience not only poorer health outcomes, but more hospital admissions and ...