Study of Non-Invasive Deep Brain Stimulation With Low Intensity Focused Ultrasound Pulse (LIFUP) for Mild Cognitive Impairment (MCI) and Mild Alzheimer’s Disease (AD)
Sponsor:
Brief Summary:
using a device called Low Intensity Focused Ultrasound Pulsation (LIFUP), for persons with
mild cognitive impairment (MCI) or mild (early-stage) Alzheimer’s disease (AD). As a
secondary aim, the investigators will explore whether this brief intervention is associated
with improvements in cognitive functioning immediately and one week following the
intervention.
Subjects will be randomly assigned to one of two experimental groups: either the LIFUP
administration will be designed to increase the activity of neurons in a certain part of the
brain or decrease the activity of neurons.
The investigators will study up to 8 subjects with MCI or mild AD. Initially, subjects will
undergo a screening assessment with a study physician to determine medical and psychiatric
history, establish AD diagnosis, and undergo a blood draw, if standard recent labs for
dementia and EKG are unavailable. Subjects that meet criteria and agree to participate in the
study will undergo a follow-up visit. In the baseline measurement visit, participants will
first undergo neuropsychological testing. Participants will be randomly assigned to one of
two LIFUP pulsing paradigms. Participants will then be administered four successive LIFUP
treatments while the participants are in a functional magnetic resonance imaging (MRI). Sixty
minutes following the administration, participants will undergo a second neuropsychological
test. A final follow-up assessment will be administered at one week.
Criteria
– Mild cognitive impairment or mild (early-stage) AD diagnosis through medical record
review
– Agreement to participate in a clinical and brain imaging study.
– Age 55 years or older.
– No significant cerebrovascular disease as determined by a modified Ischemic Score of ≤
4.
– Availability of a study partner (next of kin, family member) to attend all visits and
to provide surrogate consent should it be determined that the participant does not
have capacity.
– Adequate visual and auditory acuity to allow neuropsychological testing.
– Screening laboratory tests and ECG without significant abnormalities that might
interfere with the study.
– Use of cholinesterase inhibitors for AD (Aricept, Namenda, etc.) will be allowed as
long as the participant has been on a stable dose for at least two months.
– There must be a family member or caregiver available to make sure the participant
gives informed consent, and in case the participant develops cognitive impairment that
interferes with independent study participation.
Exclusion Criteria:
– Evidence of any other major neurologic or other physical illness that could produce
cognitive deterioration, except for mild cognitive impairment (MCI) and any history of
stroke or diabetes.
– History of myocardial infarction within the previous year or unstable cardiac disease.
– Uncontrolled hypertension (systolic BP > 170 or diastolic BP > 100), history of
significant liver disease, clinically significant pulmonary disease, diabetes, or
cancer.
– Major psychiatric disorders, such as bipolar disorder or schizophrenia, or persons
with current untreated major depression
– Current diagnosis or significant history of alcoholism or drug dependence.
– Participants taking medications known to influence cognitive functioning will be
excluded. Medications that will be excluded include: centrally active beta-blockers,
narcotics, clonidine, anti-Parkinsonian medications, benzodiazepines, systemic
corticosteroids, and medications with significant anticholinergic effects,
anti-convulsants, or warfarin. During the screening visit, physicians will review all
medications and determine whether the type, dose, and interaction of medications are
likely to impact cognition and determine exclusion based on these factors.
– Use of any investigational drugs within the previous month or longer, depending on the
drug’s half-life.
– Contraindication for fMRI scan (e.g. metal in body, claustrophobia).
Locations
- UCLA Longevity Center, Los Angeles, California, United States, 90095
