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Deep Brain Stimulation in Mild Alzheimer's Disease (ADvance II Study)

Recruiting

This clinical trial will test deep brain stimulation (DBS) of the fornix as a treatment for people with mild Alzheimer's disease. DBS uses a surgically implanted medical device, similar to a cardiac pacemaker, to deliver electrical pulses to precisely targeted areas of the brain. In this case, the targeted region is the fornix, a major pathway in the brain's memory circuit that is one of the first areas affected by Alzheimer's disease. The fornix connects the hippocampus, a part of the brain that controls memory, with other areas of the brain.

Minimum Age Maximum Age Gender Healthy Volunteers
65 Years N/A All No
August 1, 2019
October 1, 2024
210

  • Probable Alzheimer's disease with mild dementia (Clinical Dementia Rating global rating of 0.5 or 1 at screening; ADAS-cog-11 score of 10-24 inclusive at screening)
  • Moderate to marked elevation in cerebrospinal fluid tau
  • Moderate to marked decrement in cerebrospinal fluid A
  • Available caregiver or other knowledgeable informant who can reliably report on daily activities and function and signs informed consent
  • Good surgical candidate for placement of a deep brain stimulator as judged by the DBS surgical team
  • Taking a stable dose of cholinesterase inhibitor medication (donepezil, galantamine, or rivastigmine) for at least 60 days, with no change in dose during the trial

  • Neuropsychiatric Inventory total score 10 or score 4 in any NPI domain (clinically significant neuropsychiatric symptoms)
  • Modified Hachinski ischemia scale score > 4 at screening
  • At risk for suicide or attempted suicide in the past 2 years
  • Current major psychiatric disorder such as schizophrenia, bipolar disorder, or major depressive disorder
  • Current alcohol or substance abuse
  • History of moderate or more severe traumatic brain injury in the 2 years prior to joining study
  • History of brain tumor, subdural hematoma, or other clinically significant lesion seen on brain imaging
  • History of seizure disorder
  • Unable to have PET scan (e.g., insulin dependent diabetes) or MRI scan (e.g., implanted metallic devices, cardiac pacemaker)
  • Radiation exposure in the past year that, in combination with the radiation exposure from this study, would exceed 5 rem
  • Abnormal cardiovascular, neurovascular disorder, or medications that would preclude participation in the study
  • Life expectancy of less than 1 year
  • Enrolled in another clinical trial

In this Phase III trial, participants will be assigned to receive either an active DBS device or an inactive (placebo) device implanted in the brain. Researchers will evaluate and compare changes in cognition and function after 12 months. Results from a pilot study showed that DBS of the fornix may slow the rate of cognitive decline, compared to the expected rate of decline in mildly impaired people. It may also improve glucose metabolism in the brain associated with Alzheimer's. 

Name City State Zip Status Primary Contact
Barrow Neurological Institute
Phoenix Arizona 85013 Recruiting Margeaux Snell
800-392-2222
University of Southern California
Los Angeles California 90033 Recruiting Amanda Romano
323-442-9869
Amanda.Romano@med.usc.edu
Stanford University
Stanford California 94305 Recruiting Bharati Sanjanwala
650-721-2830
bharatis@stanford.edu
University of Florida
Gainesville Florida 32601 Recruiting Camille Swartz
352-273-5612
Cami.Swartz@neurology.ufl.edu
University of South Florida
Tampa Florida 33613 Recruiting Julie Samson
813-974-1201
jsamson@health.usf.edu
Johns Hopkins University
Baltimore Maryland 21224 Recruiting John Kim
410-550-4696
jkim587@jhmi.edu
Wake Forest Baptist Health
Winston-Salem North Carolina 27157 Recruiting Wendy Jenkins
336-716-3842
wejenkin@wakehealth.edu
Rhode Island Hospital
Providence Rhode Island 02903 Recruiting Owen Leary
401-606-8388
owen.leary@lifespan.org
University of Texas
Austin Texas 78712 Recruiting Ashleigh Smith
512-270-9039
Ashleigh.smith@austin.utexas.edu
Medical College of Wisconsin
Milwaukee Wisconsin 53226 Recruiting Karen Schmidt, RN
414-955-0674
kaschmidt@mcw.edu
Toronto Western Hospital
Toronto Ontario Recruiting Martha Lenis, BHA
(416) 603-5800
Martha.lenis@uhnresearch.ca

Functional Neuromodulation Ltd

Name Phone Email
Kristen Drake 214-543-8321 kdrake@fxneuromod.com
Robyn Moxon 6512466941 rmoxon@fxneuromod.com

NCT03622905

ADvance II: A 12-month Double-blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Deep Brain Stimulation of the Fornix (DBS-f) in Patients With Mild Probable Alzheimer's Disease