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(352) 733-0111

AL002 Feasibility Study for Treatment of Alzheimer s Disease

  • Status
    Accepting Candidates
  • Age
    50 Years - 85 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

The purpose of this study is to evaluate the safety and efficacy of the ExAblate Model 4000 Type 2.0 System as a tool to disrupt the blood-brain barrier (BBB) in patients with probable Alzheimer's Disease (AD).

Description

This is a prospective, multi-center, single-arm study to evaluate the safety and efficacy of BBB disruption using the ExAblate Model 4000 Type 2.0 (220 kHz) system. Patients with diagnosis of Probable Alzheimer's Disease may qualify for a clinical trial to have three serial ExAblate BBB disruption procedures in specific areas in the brain. This study will be conducted at up to 8 sites in the United States and will enroll up to 30 patients.

Details

Full study title Assessment of Safety and Efficacy of Exablate Blood-Brain Barrier Disruption for the Treatment of Patients with Probable Alzheimer's Disease
Protocol number OCR42999
ClinicalTrials.gov ID NCT03671889
Phase N/A

Eligibility

Inclusion Criteria:

  1. Male or Female between 50-85 years of age

  2. Probable Alzheimer's Disease (AD)

  3. If taking concurrent Alzheimer's medication, has been on the medication for at least 2 months with a stable dose for at least 3 months

  4. Able to communicate sensations during the ExAblate MRgFUS procedure

  5. Ambulatory

Exclusion Criteria:

  1. MRI Findings

  2. Presence of unknown or MR unsafe devices anywhere in the body

  3. Significant cardiac disease or unstable hemodynamic status

  4. Relative contraindications to ultrasound contrast agent or PET amyloid tracer

  5. History of a bleeding disorder

  6. History of liver disease

  7. Known cerebral or systemic vasculopathy

  8. Significant depression and at potential risk of suicide

  9. Any contraindications to MRI scanning

  10. Any contraindication to lumbar puncture for collection of cerebral spinal fluid

  11. Untreated, uncontrolled sleep apnea

  12. History of seizure disorder or epilepsy

  13. Severely Impaired renal function

  14. Currently in a clinical trial involving an investigational product or non-approved use

of a drug or device or in any other type of medical research

  1. Chronic pulmonary disorders

  2. Positive human immunodeficiency virus (HIV)

  3. Known apolipoprotein E allele (ApoE4) homozygosity

Lead researcher

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.