Brain Stimulation + Methylphenidate for Dementia
(PRIME Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether combining methylphenidate with Intermittent Theta Burst Stimulation can reduce apathy in individuals with Alzheimer's disease or a mix of Alzheimer's and vascular dementia. One group will receive both treatments, while another will receive only the brain stimulation. Ideal candidates for this trial are those with Alzheimer's or related dementia who frequently feel uninterested or lack motivation in daily activities. Participants should have a care partner who spends at least 10 hours a week with them. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group.
Do I have to stop taking my current medications for the trial?
The trial requires that you are on a stable dose of psychotropic medication, but you cannot be taking any dopaminergic agents other than methylphenidate. If you are on such medications, you may need to stop them to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that intermittent theta burst stimulation (iTBS) is generally easy for people to handle. Some studies found this brain stimulation method safe for those with mild memory problems. Few reports of serious side effects suggest it might be a safe choice.
Methylphenidate, often used for attention disorders, has also been researched for treating lack of motivation in Alzheimer's patients. Studies indicate it is usually safe, with side effects similar to those of a placebo. This suggests methylphenidate is a safe treatment, especially since it's already approved for other uses.
Both treatments in this trial are supported by evidence showing they are generally well-tolerated, but individual experiences can vary.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for dementia because they combine innovative brain stimulation with medication to tackle symptoms like apathy. Most treatments for dementia focus on managing memory loss and cognitive decline, often using drugs like cholinesterase inhibitors or memantine. However, this trial explores intermittent theta burst stimulation (iTBS), a type of non-invasive brain stimulation, alongside methylphenidate, known for enhancing attention and motivation. iTBS offers a novel way to potentially boost brain activity in specific regions, while methylphenidate acts quickly to energize and motivate patients. This combination could provide a faster and more effective approach to addressing some of the challenging behavioral aspects of dementia.
What evidence suggests that this trial's treatments could be effective for apathy in dementia?
Research has shown that intermittent theta burst stimulation (iTBS) can help with memory and thinking problems in Alzheimer's disease. Studies have found that iTBS might slow memory loss and improve brain function in both humans and animals. In this trial, some participants will receive only iTBS. Methylphenidate has been found to reduce lack of interest and improve mood and thinking in some Alzheimer's patients. In this trial, other participants will receive a combination of methylphenidate and iTBS. These treatments are being studied for their potential to improve the quality of life for people with dementia.16789
Who Is on the Research Team?
Krista Lanctot, PhD
Principal Investigator
Sunnybrook Research Institute
Are You a Good Fit for This Trial?
This trial is for individuals with Alzheimer's disease or mixed AD/vascular dementia who show significant apathy. They must have an MMSE score between 10-28, be on a stable dose of psychotropic medication, and have a care partner available at least 10 hours per week. People with unapproved pacemakers, metallic implants, history of epilepsy, major depression, use of certain dopaminergic agents other than methylphenidate or clinically significant CNS abnormalities are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive methylphenidate and/or iTBS to treat apathy in dementia
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Intermittent Theta Burst Stimulation
- Methylphenidate
Trial Overview
The study tests if combining methylphenidate (a stimulant) with non-invasive brain stimulation called intermittent theta burst stimulation can reduce apathy in dementia patients. It aims to see if this dual approach is more effective than current treatments.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
iTBS only, no medication for apathy
Participants are currently receiving methylphenidate and receive iTBS in this study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sunnybrook Health Sciences Centre
Lead Sponsor
Alzheimer Society of Canada
Collaborator
Sunnybrook Research Institute
Collaborator
Brain Canada
Collaborator
Citations
Effects of intermittent theta-burst stimulation on cognition ...
Repetitive transcranial magnetic stimulation (rTMS) has demonstrated efficacy in alleviating cognitive symptoms in Alzheimer's disease (AD) ...
Accelerated Intermittent Theta-burst Stimulation to Modify ...
(2019) showed that 3 days of iTBS delivered to the DLPFC led to cognitive improvements in a sample of Parkinson's disease patients with mild cognitive ...
The long-term effects of intermittent theta burst stimulation ...
These data indicate that 1 month of iTBS treatment ameliorates pathologies in the brain of AD mice for at least 2 months.
Effects of a periodic intermittent theta burst stimulation in ...
We aimed to explore whether repeating accelerated iTBS every three months could slow down the cognitive decline in patients with AD.
A randomized controlled study on intermittent theta pulse ...
Although preliminary studies suggest iTBS may enhance cognitive outcomes in stroke patients, existing trials are limited by small sample sizes, ...
NCT05327257 | iTBS rTMS in Mild Cognitive Impairment
The purposes of this research are to test whether it is feasible to administer a treatment protocol called intermittent theta burst stimulation (iTBS) ...
A pilot randomized controlled double-blind trial of intermittent ...
Our study will test the feasibility of using intermittent theta burst stimulation (iTBS) technique of rTMS in MCI, pilot test the study design, ...
Accelerated iTBS-Induced changes in resting-state ...
Published results of our Phase I safety and feasibility trial of accelerated intermittent theta burst stimulation (a-iTBS) in mild cognitive impairment (MCI) ...
A phase I trial of accelerated intermittent theta burst rTMS for ...
This study provides critical preliminary data to motivate and inform subsequent clinical trials to determine the efficacy of iTBS to improve cognition in ...
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