tACS for Amyloid-β Reduction in Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT03290326|
Recruitment Status : Recruiting
First Posted : September 21, 2017
Last Update Posted : December 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Device: Transcranial Alternating Current Stimulation (tACS)||Not Applicable|
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. There is no current treatments that alter disease progression.
Investigators will recruit 20 individuals with AD with evidence of amyloid placques in the brain through Positron Emission Tomography (PET) imaging. Investigators will use a novel approach, transcranial alternating current stimulation (tACS), to target the region of maximum amyloid burden in the brain. All participants will receive tACS. Each individual's participation in the study will consist of approximately 16 visits: 3 days for screening/baseline procedures as described below, 10 tACS study visits, and 3 days for follow-up assessments. Subjects will undergo baseline cognitive assessment, structural and functional MRI characterization, and resting-state EEG measurement. Additionally, patients will undergo a tACS-EEG recording session to assess brain plasticity levels and identify markers of response to stimulation. All subjects will then undergo 10 1-hour sessions of gamma-frequency (40 Hz) tACS, targeted to the region of maximal tracer uptake on the amyloid PET study. Subjects will take a standardized adverse effect questionnaire before and after each session and complete a short cognitive test after each session to demonstrate safety and tolerability. At the end of the 10 sessions, subjects will then repeat the baseline assessments, followed by repeat amyloid PET imaging to assess for changes in amyloid burden.
Investigators anticipate that targeting the region of amyloid burden in the brain with tACS will reduce the amyloid burden as evidence by the follow up PET imaging and show improvement on electrophysiological measures of brain function and on cognitive testing. If our prediction is correct, this will will provide a critical first step in the development of a novel intervention to prevent and treat AD.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility and Safety of a High-Frequency Transcranial Alternating Current Stimulation Intervention for Amyloid-β Reduction in Alzheimer's Disease|
|Actual Study Start Date :||November 27, 2017|
|Estimated Primary Completion Date :||August 26, 2019|
|Estimated Study Completion Date :||September 1, 2019|
Transcranial alternating current stimulation (tACS) tuned at the frequency of 40Hz (gamma frequency) will be applied for 1 hour in 10 sessions on consecutive weekdays. The tACS intervention (10 sessions) will be preceded and followed by amyloid PET imaging as well as a clinical/cognitive evaluation. The assessment of adverse effects will constitute a Primary outcome measure. Changes in amyloid load in the stimulated brain region will be evaluated and constitute a secondary outcome of the study. Clinically relevant changes in cognitive and clinical scores will be also evaluated as secondary outcomes. Stimulation will be also preceded and followed by electroencephalography (EEG) recording aimed at assessing changes in spectral power in the gamma band.
Device: Transcranial Alternating Current Stimulation (tACS)
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.
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: Up to six weeks ]Adverse Events as a result of tACS stimulation will be reported
- PET Amyloid burden [ Time Frame: Up to six weeks ]Changes in the amyloid load observed via PET imaging will be evaluated by comparing PET data acquired before and after the 10 tACS sessions.
- EEG gamma-band spectral power [ Time Frame: Up to six weeks ]Changes in the spectral power in the low-mid gamma band (35-80Hz) will be measured using electroencephalography (EEG) and reported in term of Pre-Post tACS differences.
- Adas-Cog score [ Time Frame: Up to six weeks ]Change in Adas-Cog score will be reported, to document a potential clinical benefit of tACS.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290326
|Contact: Emiliano Santarnecchifirstname.lastname@example.org|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Rachel Paciorek 617-667-9088 email@example.com|
|Principal Investigator:||Emiliano Santarnecchi||Beth Israel Deaconess Medical Center|