What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease include cholinesterase inhibitors, memantine, and non-invasive brain stimulation techniques such as transcranial magnetic stimulation (TMS). Cholinesterase inhibitors can cause gastrointestinal side effects, while memantine is generally well-tolerated but may cause dizziness, headache, and confusion. Non-invasive brain stimulation methods like TMS have shown mild side effects, including lightheadedness, tingling, and tinnitus. Overall, these treatments are associated with manageable side effects, but individual responses can vary.

What prior FDA approvals exist?

The FDA has approved several treatments for Alzheimer's Disease that focus on modulating neuronal activity. Cholinesterase inhibitors such as donepezil and galantamine have shown promise in improving cognitive function by increasing acetylcholine levels in the brain. Memantine, another FDA-approved drug, works by regulating glutamate activity to prevent neuronal damage. These treatments aim to enhance communication between nerve cells and are somewhat related to the concept of non-invasive brain stimulation, which also seeks to modulate neuronal activity to improve cognitive function.

What other types of research exist?

Peripheral electrical nerve stimulation shows potential as a novel alternative treatment for Alzheimer's Disease patients, particularly in enhancing rest-activity rhythm. However, further research is required to confirm its effectiveness.

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Non-invasive Brain Stimulation

Brain Stimulation for Alzheimer's Disease (MemStim-lab Trial)

N/A

Waitlist Available

Led By Alvaro Pascual-Leone, Dr.

Research Sponsored by Hebrew SeniorLife

Eligibility Criteria Checklist

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

Must have

Healthy young participants: age 21-35 without any cognitive impairment (based on MoCA or TICS) and willing and capable to give informed consent for the participation in the study after it has been thoroughly explained

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 lab-visits will occur at least 2 days apart within one month

Awards & highlights

No Placebo-Only Group

Summary

This trial uses gentle electrical currents to stimulate the brain in young and older adults, including those with mild memory issues, to see if it can improve memory by making the brain more active. Electrical stimulation has been employed to boost memory training effects.

Who is the study for?

This trial is for young adults (21-35) with no cognitive issues, older adults (55+) without cognitive impairment, and older individuals (55+) diagnosed with mild Alzheimer's or Mild Cognitive Impairment. Participants must be able to consent and perform tasks required by the study. Those with severe cognitive deficits, psychiatric conditions, blindness, or who can't undergo brain stimulation are excluded.

What is being tested?

The trial is testing transcranial alternating current stimulation (tACS), a non-invasive brain stimulation technique, to see if it improves memory function in people with mild Alzheimer's Disease.

What are the potential side effects?

While not explicitly stated here, tACS may cause side effects like headache, scalp tingling or itching during application, fatigue after treatment sessions and in rare cases seizures.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 21-35 years old, mentally fit, and can consent to the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 lab-visits will occur at least 2 days apart within one month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 lab-visits will occur at least 2 days apart within one month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 lab-visits will occur at least 2 days apart within one month for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Behavioral performance measured with Montreal Cognitive Assessment (MoCA)

Spatiotemporal dynamic changes measured with electroencephalography (EEG)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: Healthy older participantsActive Control1 Intervention

A group of 20 cognitively intact older participants (age 55+)

Group II: Healthy young participantsActive Control1 Intervention

a group of 20 cognitively intact younger participants (age 21-35)

Group III: Older MCI/mild AD participantsActive Control1 Intervention

A group of 20 cognitively impaired older participants (age 55+)

0 / 1Eligibility 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 (AD) include cholinesterase inhibitors (e.g., donepezil) and NMDA receptor antagonists (e.g., memantine). Cholinesterase inhibitors work by preventing the breakdown of acetylcholine, a neurotransmitter important for learning and memory, thereby enhancing cholinergic function. Memantine regulates glutamate activity to prevent excitotoxicity, which can damage neurons. Non-invasive brain stimulation, such as transcranial magnetic stimulation (TMS), modulates neuronal activity by using magnetic fields to stimulate nerve cells in the brain. This can enhance synaptic plasticity and improve cognitive functions. These mechanisms are crucial for AD patients as they aim to slow cognitive decline, improve memory, and enhance overall brain function.