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tACS for Alzheimer's Disease
Phase 1 & 2
Recruiting
Led By Emiliano Santarnecchi, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 45 years old
Clinical Diagnosis of early to moderate AD*
Must not have
Current history of poorly controlled migraines including chronic medication for migraine prevention
Contraindication for undergoing MRI or receiving TMS or tACS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 16 weeks
Awards & highlights
Summary
This trial will investigate whether transcranial alternating current stimulation (tACS) can decrease the amount of amyloid and tau in people with Alzheimer's Disease (AD), as compared to Sham (placebo) stimulation.
Who is the study for?
This trial is for adults over 45 with early to moderate Alzheimer's Disease, confirmed by a doctor and positive amyloid PET imaging. Participants must have memory issues, an MMSE score of at least 18, be on stable memory loss medication for six weeks, and not have major psychiatric conditions or contraindications like metal implants or history of seizures.
What is being tested?
The study tests if brain stimulation using transcranial alternating current stimulation (tACS) can reduce amyloid and tau proteins in the brain compared to placebo. It explores different tACS doses over 2-4 weeks to see if it improves memory and thinking in Alzheimer's patients.
What are the potential side effects?
Potential side effects may include discomfort at the electrode sites on the scalp, headache, dizziness, nausea or other mild physical sensations during or after treatment. There might also be a small risk of seizure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at least 45 years old.
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I have been diagnosed with early to moderate Alzheimer's disease.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I frequently take medication to prevent severe headaches.
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I cannot have MRI scans or undergo TMS or tACS treatments.
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I have a neurological condition other than dementia, or I've had neurosurgery or head trauma with lasting effects.
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I don't have chronic conditions like heart issues or asthma that could worsen with a seizure.
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I am not pregnant or breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Alzheimer's Disease Assessment Scale -Cog Score
Change in Gamma activity
Incidence of Treatment-Emergent Adverse Events
+2 moreSecondary study objectives
Amyloid
Follow-up Cognitive Evaluation
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: 4 weeks of twice daily tACS sessionsExperimental Treatment1 Intervention
20 days (Monday-Friday) of 1-hour sessions of tACS twice per day
Group II: 4 weeks of daily tACS sessionsExperimental Treatment1 Intervention
20 daily (Monday-Friday) 1-hour sessions of tACS stimulation
Group III: 2 weeks of daily tACS sessionsExperimental Treatment1 Intervention
10 daily (Monday-Friday) 1-hour sessions of tACS stimulation
Group IV: 2/4 weeks of Sham tACS sessionsPlacebo Group1 Intervention
10/20 days (Monday-Friday) of 1-hour sessions of tACS once/twice per day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Alternating Current Stimulation (tACS)
2019
N/A
~130
Find a Location
Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,733 Previous Clinical Trials
28,054,948 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,993 Previous Clinical Trials
13,230,666 Total Patients Enrolled
Beth Israel Deaconess Medical CenterOTHER
848 Previous Clinical Trials
12,930,049 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I frequently take medication to prevent severe headaches.I cannot have MRI scans or undergo TMS or tACS treatments.You have had problems with drugs or alcohol in the past six months.I am at least 45 years old.I have a history of seizures or epilepsy, except for a single benign seizure.My doctor will review my medications to decide if I can join the trial.I have been on a steady dose of memory loss medication for at least 6 weeks.I have a neurological condition other than dementia, or I've had neurosurgery or head trauma with lasting effects.You have a history of severe mental health conditions like depression, bipolar disorder, or psychosis.You have been diagnosed with mild to severe dementia.I have been diagnosed with early to moderate Alzheimer's disease.I have had fainting spells that might be seizures.My brain scan shows changes or small strokes that don't affect my thinking or movement.I don't have chronic conditions like heart issues or asthma that could worsen with a seizure.I am not pregnant or breastfeeding.The study doctor will confirm the diagnosis by considering the participant's cognitive evaluation and personal history.You have problems with your memory or have had memory issues in the past.You do not have a history of intellectual disability.
Research Study Groups:
This trial has the following groups:- Group 1: 4 weeks of daily tACS sessions
- Group 2: 4 weeks of twice daily tACS sessions
- Group 3: 2/4 weeks of Sham tACS sessions
- Group 4: 2 weeks of daily tACS sessions
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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