North Coast Medical Activadose II for Alzheimer's Disease

(MEMORI Trial)

RA
Overseen ByResearch Assistant
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The Mind Research Network

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called transcranial Electrical Stimulation (tES) to determine its effectiveness in improving memory in older adults who are healthy or have mild cognitive impairment (MCI) or early-stage Alzheimer's disease. The treatment applies electrical stimulation to the right temple and left arm for up to 40 minutes using a device called the North Coast Medical Activadose II. Participants may qualify if they are right-handed, learned English by age seven, and have no history of severe mental health issues or excessive substance use. If successful, this treatment could enhance the quality of life for individuals with Alzheimer's and their families. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to significant advancements in Alzheimer's treatment.

Will I have to stop taking my current medications?

You may need to stop taking medications with significant psychotropic effects (drugs that affect mood, perception, or behavior) to participate in this trial. The protocol does not specify other medication restrictions.

What prior data suggests that this tES protocol is safe for older adults?

Research shows that transcranial Electrical Stimulation (tES) is generally safe. In past studies, this method improved learning and performance in young adults. The treatment applies a small electrical current to specific areas, such as the right temple and left arm.

Although exact safety data for this trial is unavailable, using tES with devices like the North Coast Medical Activadose II is considered low-risk. The device monitors and controls the electrical current in real-time to ensure safety. Side effects are usually mild, such as slight tingling or skin irritation at electrode sites.

Overall, various studies have safely used tES, suggesting it is a low-risk option for improving memory in older adults with mild cognitive impairment or early Alzheimer's disease.12345

Why are researchers excited about this trial?

Most treatments for mild cognitive impairment and early-stage Alzheimer’s, like cholinesterase inhibitors and memantine, focus on managing symptoms by affecting neurotransmitter systems. However, the North Coast Medical Activadose II uses a technique called transcranial electrical stimulation (tES), which is unique because it directly stimulates brain activity through electrodes placed on the scalp. Researchers are excited about this method because it offers a non-invasive way to potentially enhance memory by directly influencing neural circuits. The experimental arm applies a higher current, which could amplify the therapeutic effects, while the placebo comparator ensures rigorous testing of its true impact. This approach opens new possibilities for memory enhancement with fewer side effects compared to traditional medications.

What evidence suggests that this tES protocol is effective for improving memory in older adults?

Research has shown that transcranial electrical stimulation (tES) can significantly enhance learning and performance. In young adults, tES improved learning nearly fourfold compared to an inactive treatment. This trial will test two different tES approaches: Full Current tES, delivering up to 4 milliamps, and Partial Current tES, delivering 0.1 milliamp as a placebo comparator. This suggests that tES might enhance memory in older adults, including those with mild memory problems or early Alzheimer's disease. The treatment applies a small electrical current to specific body areas, which is believed to enhance brain function. Early results from other studies indicate that tES positively affects brain activity and cognitive skills. While these findings are promising, further research is needed to confirm these effects in older adults with memory issues.678910

Who Is on the Research Team?

VC

Vincent Clark, PhD

Principal Investigator

University of New Mexico

Are You a Good Fit for This Trial?

Inclusion Criteria

You have someone who can help you remember and report your medical history.
You must be between 50 and 90 years old and have a photo ID that shows your date of birth.
You are required to be right-handed and learned to speak English before the age of seven.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial Electrical Stimulation (tES) treatment applied to the right temple and left arm for up to 40 minutes

1 session
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including performance accuracy on a complex visual learning and categorization task

Within one hour after treatment

What Are the Treatments Tested in This Trial?

Interventions

  • North Coast Medical Activadose II
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Full Current tESExperimental Treatment1 Intervention
Group II: Partial Current tESPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Mind Research Network

Lead Sponsor

Trials
27
Recruited
2,300+

Citations

PMC - PubMed CentralParticipants received four interventions in a randomized order: (1) transcranial pulsed current stimulation (tPCS) and active transcranial ...
NCT06966128No information is available for this page.
Transcranial electrical stimulation (tES) mechanisms and its ...In this review, we describe transcranial electrical stimulation (tES) techniques currently being used in neuroscientific research, ...
Systematic Review and Meta-analysis of the Effects ...Although tES does not appear to have a substantial overall effect on sleep, tACS may improve total sleep time, and pre-sleep offline tES may prolong sleep ...
The Effects of Transcranial Electrical Stimulation on Human ...Here, a comprehensive review was undertaken to summarize the neuroimaging evidence of how tES affects human motor skills.
ActivaDose IIUpgraded features for better performance. The ActivaDose® II has two controls to operate dose and current, with optional push-knob or turn capabilities.
ActivaDose®IIComes with a Single Channel Controller, lead wires, batteries, an instruction manual, and is backed by a one-year warranty.
ActivaDose IIFeatures 2 controls to operate dose and current, with optional push-knob or turn capabilities; High-contrast display indicates dose, time and current
ActivaDose IICan be used for Iontophoresis or for tDCS; Equipped with dose and timer knobs; Real time current output display; Real time resistance/impedance monitoring ...
North Coast ActivaDose® IIIncludes visual indicators and audible alerts for resistance limit, dose and current limits, and electrode reject. Time calculations are performed automatically ...
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