What is the mechanism of action of this treatment?

The most common treatments for Alzheimer's Disease include cholinesterase inhibitors (donepezil, rivastigmine, and galantamine) and memantine. Cholinesterase inhibitors work by increasing levels of acetylcholine, a neurotransmitter crucial for memory and learning, by inhibiting the enzyme that breaks it down. Memantine regulates glutamate activity, another neurotransmitter involved in cognitive functions, by acting as an NMDA receptor antagonist. These treatments are significant for Alzheimer's patients as they help manage symptoms and improve cognitive and global functioning, thereby enhancing quality of life despite not altering the disease's progression.

What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease, such as cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and memantine, have several known side effects. Cholinesterase inhibitors often cause gastrointestinal issues like nausea, vomiting, and diarrhea, as well as muscle cramps, fatigue, and insomnia. Memantine, used for moderate to severe cases, is generally better tolerated but can lead to dizziness, headache, confusion, and constipation. These treatments focus on symptom management and require careful monitoring to handle side effects.

What prior FDA approvals exist?

The FDA has approved several cholinesterase inhibitors for the treatment of Alzheimer's Disease, including donepezil, rivastigmine, and galantamine. These drugs work by increasing cholinergic transmission and provide modest symptomatic benefits in cognition and global functioning. Another approved drug is memantine, which is used for moderate to severe Alzheimer's and can be combined with cholinesterase inhibitors. These treatments align with the Virtual Care Coordination trial's focus on tailored assessment and standardized protocols for managing dementia symptoms.

What other types of research exist?

Promising alternatives to Virtual Care Coordination for Alzheimer's Disease patients include Augmented Video Consultations (AVC) and Cognitive Behavioral Therapy for Insomnia (CBT-I). AVC enables real-time patient examinations and promotes person-centered care, which can be particularly beneficial for older adults in care homes. CBT-I, especially when delivered digitally, can help manage insomnia and reduce reliance on sedative-hypnotic medications, improving overall well-being. Additionally, the use of virtual reality (VR) in dementia care education shows potential in enhancing caregiver training and empathy, which could indirectly benefit patient care.

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Behavioural Intervention

Virtual Support Program for Dementia (ABCV Trial)

N/A

Recruiting

Led By Alexia M Torke, MD, MS

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients aged 65 and older

Diagnosis of Alzheimer's disease and related dementias (ADRD) based on ICD criteria in primary care problems list

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months after the 12 month intervention period

Awards & highlights

Summary

This trial involves frequent online meetings with nurses or social workers to help patients with dementia and their caregivers. The care coordinators assess needs and provide support to manage symptoms, stress, medications, other health issues, and future care planning.

Who is the study for?

This trial is for individuals with dementia or Alzheimer's Disease. Participants will engage in a virtual care program over one year, managed by nurses or social workers. The program includes regular check-ins and personalized plans to manage symptoms and caregiver stress.

What is being tested?

The Aging Brain Care Virtual Program is being tested to see if it can help manage dementia and Alzheimer's symptoms through monthly virtual visits initially, then quarterly as needed. It focuses on behavioral management, stress relief for caregivers, medication oversight, comorbidity handling, and future care planning.

What are the potential side effects?

Since this intervention is non-medical and involves virtual support sessions rather than drugs or medical procedures, there are no traditional side effects; however participants may experience varying levels of emotional response to the support provided.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 65 years old or older.

Select...

I have been diagnosed with Alzheimer's or a similar dementia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months after the 12 month intervention period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months after the 12 month intervention period

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months after the 12 month intervention period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Emergency Department Utilization

Secondary study objectives

Acceptability of the intervention score

Anticholinergic Cognitive Burden Scale score

Appropriateness of the intervention score

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

Care Partners in the intervention group will be approached and offered care coordination through the Aging Brain Care Virtual program

Group II: ControlActive Control1 Intervention

Care partners in the control group will not be approached, but outcomes data will be collected from the EMR for comparison with the intervention group.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Alzheimer's Disease include cholinesterase inhibitors (donepezil, rivastigmine, and galantamine) and memantine. Cholinesterase inhibitors work by increasing levels of acetylcholine, a neurotransmitter crucial for memory and learning, by inhibiting the enzyme that breaks it down. Memantine regulates glutamate activity, another neurotransmitter involved in cognitive functions, by acting as an NMDA receptor antagonist. These treatments are significant for Alzheimer's patients as they help manage symptoms and improve cognitive and global functioning, thereby enhancing quality of life despite not altering the disease's progression.

Find a Location

Who is running the clinical trial?

Regenstrief Institute, Inc.OTHER

26 Previous Clinical Trials

97,657 Total Patients Enrolled

Indiana University HealthOTHER

30 Previous Clinical Trials

14,928 Total Patients Enrolled

Indiana UniversityLead Sponsor

1,019 Previous Clinical Trials

1,113,355 Total Patients Enrolled

~459 spots leftby Jun 2025

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