Status:
COMPLETED
Deep Brain Stimulation with LIFUP for Mild Cognitive Impairment and Mild Alzheimer's Disease
Lead Sponsor:
University of California, Los Angeles
Conditions:
Brain Imaging
Mild Cognitive Impairment
Eligibility:
All Genders
55+ years
Phase:
NA
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 ...
Detailed Description
Alzheimer disease (AD) is a neurodegenerative condition and the most common cause of dementia or a functional impairment in memory and other cognitive abilities. Prior to developing the functional imp...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
November 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2023
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03347084
Start Date
November 10 2018
End Date
October 1 2023
Last Update
September 5 2024
Active Locations (1)
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1
UCLA Semel Institute
Los Angeles, California, United States, 90095