Gamma Induction for Amyloid Clearance in Alzheimer's Disease

Who is this study for? Older adult patients with Alzheimer's Disease
What treatments are being studied? Transcranial Alternating Current Stimulation
Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: f
View:

• Clinical Diagnosis of early to moderate AD\*

‣ Mini Mental State Examination (MMSE) ≥ 18

⁃ Clinical Dementia Rating (CDR) ≥ 0.5

⁃ Demonstration or history of memory impairments.

∙ Confirmation of diagnosis will be made by the study MD based on a holistic consideration of the participant's cognitive evaluation and history.

• Amyloid positive PET imaging

• At least 45 years old

• On a stable dose of medications for memory loss including cholinesterase inhibitors (e.g. donepezil, rivastigmine or memantine) as defined as 6 consecutive weeks of treatment at an unchanging dose

• Minimum of completed 8th grade education

• No history of intellectual disability

Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Contact Information
Primary
Stacey Monsell
smonsell@bidmc.harvard.edu
617-667-9088
Backup
Julianne Reilly
jrreilly@mgh.harvard.edu
Time Frame
Start Date: 2019-08-05
Estimated Completion Date: 2024-11
Participants
Target number of participants: 55
Treatments
Experimental: 2 weeks of daily tACS sessions
10 daily (Monday-Friday) 1-hour sessions of tACS stimulation
Experimental: 4 weeks of daily tACS sessions
20 daily (Monday-Friday) 1-hour sessions of tACS stimulation
Experimental: 4 weeks of twice daily tACS sessions
20 days (Monday-Friday) of 1-hour sessions of tACS twice per day
Sham_comparator: 2/4 weeks of Sham tACS sessions
10/20 days (Monday-Friday) of 1-hour sessions of tACS once/twice per day
Authors
Emiliano Santarnecchi
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital
Collaborators: National Institute on Aging (NIA), Beth Israel Deaconess Medical Center, National Institutes of Health (NIH)

This content was sourced from clinicaltrials.gov