Status:
COMPLETED
tACS for Amyloid-β Reduction in Alzheimer's Disease
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Alzheimer Disease
Eligibility:
All Genders
45+ years
Phase:
NA
Brief 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. The evidence suggests that both amyloid...
Detailed Description
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 alt...
Eligibility Criteria
Inclusion
- Clinical Diagnosis of mild AD defined by: Clinical Dementia Rating (CDR) = 0.5-1, Mini Mental State Examination (MMSE) \>/= 20, Demonstration or history of memory impairments
- 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
- Intelligence Quotient (IQ) \> 85 as determined by the Wechsler Test of Adult Reading (WTAR) and no history of intellectual disability
Exclusion
- Current history of poorly controlled migraines including chronic medication for migraine prevention
- Current or past history of any neurological disorder other than dementia, such as epilepsy, stroke, progressive neurologic disease (e.g. multiple sclerosis) or intracranial brain lesions; and history of previous neurosurgery or head trauma that resulted in residual neurologic impairment.
- Past or current history of major depression, bipolar disorder or psychotic disorders, or any other major psychiatric condition.
- Contraindication for undergoing MRI or receiving Transcranial Magnetic Stimulation (TMS) or tACS,
- • History of fainting spells of unknown or undetermined etiology that might constitute seizures.
- History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG or immediate (1st degree relative) family history of epilepsy; with the exception of a single seizure of benign etiology (e.g. febrile seizure) in the judgment of the investigator.
- Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.).
- Metal implants (excluding dental fillings) or devices such as pacemaker, medication pump, nerve stimulator, Transcutaneous Electrical Nerve Stimulator (TENS) unit, ventriculo-peritoneal shunt, cochlear implant, unless cleared by the study MD.
- Substance abuse or dependence within the past six months.
- Medications will be reviewed by the responsible MD and a decision about inclusion will be made based on the following: The patient's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination of Central Nervous System (CNS) active drugs.
- All female participants that are pre-menopausal will be required to have a pregnancy test; any participant who is pregnant will not be enrolled in the study.
- BMI \> 40 kg/m2. We will limit the BMI to \<40 kg/m2 because of weight limits of the scanner bed and width limits of the MRI.
- Subjects who, in the investigator's opinion, might not be suitable for the study
- A hair style or head dress that prevents electrode contact with the scalp or would interfere with the stimulation (for example: thick braids, hair weave, afro, wig)
Key Trial Info
Start Date :
November 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2019
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03290326
Start Date
November 27 2017
End Date
May 14 2019
Last Update
August 22 2022
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215