tACS for Alzheimer's Disease

Recruiting in Palo Alto (17 mi)

Overseen ByEmiliano Santarnecchi, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Massachusetts General Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?Alzheimer's Disease (AD) is characterized by amyloid-β (Aβ) plaque buildup and phosphorylated tau (p-tau) in the brain, as well as widespread neurodegeneration. Amyloid-β and tau are proteins that build up in the brain that may contribute to memory problems. The evidence suggests that both amyloid and tau play a critical role in AD and interventions that reliably and safely decrease the intracerebral burden of amyloid or tau could potentially be of marked clinical importance. Currently, therapeutic options are very limited and while there are pharmacologic interventions that transiently improve cognitive function, there are no treatments that alter disease progression. The purpose of this study is to see if multiple daily sessions of non-invasive brain stimulation can affect brain activity to decrease the amount of amyloid and tau in people with AD as compared to Sham (placebo) stimulation. The type of brain stimulation that will be used is called transcranial alternating current stimulation (tACS). This study will investigate different doses of tACS (2-4 weeks) and assess safety. The hope is that tACS will decrease the amount of amyloid and tau and improve memory and thinking in people with AD.

Eligibility Criteria

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.

Inclusion Criteria

I am at least 45 years old.

I have been diagnosed with early to moderate Alzheimer's disease.

Exclusion Criteria

I frequently take medication to prevent severe headaches.

I cannot have MRI scans or undergo TMS or tACS treatments.

I have a neurological condition other than dementia, or I've had neurosurgery or head trauma with lasting effects.

I don't have chronic conditions like heart issues or asthma that could worsen with a seizure.

I am not pregnant or breastfeeding.

Participant Groups

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.

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