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Participating in ADvance

Qualifying for ADvance

The ADvance Study will initially involve about 20 people that have been diagnosed with mild Alzheimer’s disease.

You may be eligible for the ADvance study
if you meet several criteria, including:

advance
  • Are 45-80 years old
  • Have been diagnosed with mild Alzheimer’s
  • Have a reliable informant (spouse, relative, caregiver) who can attend all study visits and report on your daily activities and function
  • Live at home and are likely to remain at home for the study duration
  • Are in good general health
  • Are on a stable dose for at least two months of an FDA approved drug for Alzheimer’s  -- Aricept (donepezil), Razadyne (galantamine), or  Exelon (rivastigmine)

You will be interviewed and standard screening tests will be performed to ensure that you are an appropriate candidate for this study.

What Are Volunteers Asked to Do During This Study?

The research staff will meet with you and your caregiver/family member to review the process for the study in detail. If you choose to participate, there are a few steps involved in the study, including:

Screening Visit

You and your caregiver/family member will participate in a screening visit that involves a physical exam along with several memory tests and psychological assessments to determine whether you are an appropriate candidate for the study.


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What to Expect on Your Screening Visit


Baseline Assessment

If you have completed the screening visit and are selected as appropriate for the study, you will next undergo a baseline assessment. This assessment is done during one or more visits before the scheduled implantation surgery and is conducted to establish your baseline physical skills, memory and thinking patterns before undergoing the DBS-f implantation surgery. In addition, some tests will be conducted to ensure that you are safe for surgery and to obtain images of your brain before the procedure.


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What to Expect at Your Baseline Assessment


Implantation Surgery and Setting the Device

If the baseline visit establishes that you are eligible for surgery, you will have the DBS-f device implanted while under anesthesia. All steps in this procedure will be explained to you in advance.

About 2 to 4 weeks after the implant procedure you will be assigned by chance to one of two groups – you will have a 50-50 chance of being in either group:

Brain Stimulation On – the device will be activated
Brain Stimulation Off – the device will be left off

If you are in the “On” group, your device will be turned on for the duration of the study. If you are in the “Off” group, your device will be turned on after your 12-month visit. Neither you nor your doctor will know whether you are in the “On” group or “Off” group.


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What To Expect At Your Implantation Surgery And Setting The Device


Monitoring and Assessment

After the device is set, you will return to the clinic for several regularly scheduled visits to assess your physical health, psychological state, and level of physical skills, memory and thinking patterns during the course of the study. You will be followed up for 18 months. The DBS-f system or certain components of the system are likely to remain in your body for the rest of your life.


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What to Expect at Your Follow Up Visits


 

Caution:  Investigational Device. Limited by Federal law to investigational use.