Gamma Induction for Alzheimer's Disease

Summary

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.

Conditions

• Alzheimer Disease
• Mild Cognitive Impairment

Interventions

DEVICE

Transcranial Alternating Current Stimulation (tACS)

tACS is a non-invasive way of stimulating the brain externally using weak electric currents. Electrodes are placed into a cap that you wear on your head. A weak electrical current travels back and forth through the electrodes to your head. tACS will be applied at a frequency of 40Hz and targeting the area of maximal tracer uptake on amyloid PET imaging using an individualized multielectrode design to maximize the induced electrical current to the target region.

OTHER

Sham Transcranial Alternating Current Stimulation

Placebo Control, simulation of transcranial alternating current stimulation without receiving any stimulation

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center

  collaborator OTHER

• National Institutes of Health (NIH)

  collaborator NIH

• National Institute on Aging (NIA)

  collaborator NIH

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Emiliano Santarnecchi, PhD · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-05

Primary Completion

2024-11-30

Completion

2024-11-30

FDA Device

Yes

Countries

• United States

Study Locations