Start: August 5, 2019
End: November 2023
What Is This Study About?
Transcranial alternating current stimulation (tACS) is a noninvasive method of applying weak electrical current to the brain through electrodes placed into a cap worn on the head. This study will test the effects of tACS on levels of Alzheimer's-related proteins in adults with mild to moderate Alzheimer's disease. Participants will be randomly assigned to multiple one-hour sessions daily of either active or sham stimulation for two or four weeks. Before and after the stimulation, participants will undergo assessments and tests to gauge their physical health, memory and thinking skills, and biomarkers associated with Alzheimer's disease, including positron emission tomography (PET) scans for amyloid and tau.
Do I Qualify To Participate in This Study?
- Diagnosis of mild to moderate Alzheimer's disease
- Mini-Mental State Examination score of 18 or more
- Clinical Dementia Rating score of 0.5 or more
- Demonstration or history of memory impairments
- PET scan showing positive amyloid status
- If on medications for memory loss (e.g., donepezil, rivastigmine, galantamine, memantine), must be on same dose for at least six weeks
- Minimum eighth grade education
- No history of intellectual disability
Must NOT have:
- Poorly controlled migraines, including taking medication regularly for migraine prevention
- History of neurological disorder other than dementia, such as epilepsy, stroke, progressive neurologic disease (e.g., multiple sclerosis), or intracranial brain lesions
- Previous neurosurgery or head trauma that resulted in neurologic impairment
- Noncortical disease such as confluence white matter changes (including lacunar infarcts less than 1 cm)
- History of major depression, bipolar disorder, or any other psychotic or major psychiatric condition
- Unable to receive transcranial stimulation or undergo magnetic resonance imaging, including metal implants, pacemaker, medication pump, nerve stimulator, ventriculoperitoneal shunt, and cochlear implant
- Radiation exposure for research within past year that, with PET imaging, would be above allowable limits
- History of fainting spells of unknown or undetermined cause
- History of seizures, diagnosis of epilepsy, abnormal electroencephalogram, or first-degree relative with epilepsy
- Uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (e.g., heart malformation or dysrhythmia, asthma)
- Substance abuse or dependence in past six months
- Medications will be reviewed by the study doctor
- Pregnant or breastfeeding (premenopausal females must have a pregnancy test)
- Hair style or head dress that prevents electrode contact with the scalp or would interfere with the stimulation
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Lead: Beth Israel Deaconess Medical Center
Massachusetts General Hospital
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Source: ClinicalTrials.gov ID: NCT03880240