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Deep Brain Stimulation With LIFUP for Mild Cognitive Impairment and Mild Alzheimer's Disease

About

Brief Summary

The purpose of the proposed study is to determine the feasibility of brief brain stimulation, 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.

Primary Purpose
Device Feasibility
Study Type
Interventional
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
55 Years
Maximum Age
N/A

Inclusion 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).

Join this Trial

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Study Stats
Protocol No.
16-001314
Category
Semel Institute (Psychiatry)
Contact
BIANCA DANG
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03347084
For detailed technical eligibility, visit ClinicalTrials.gov.