Start:
August 1, 2019
End:
October 2025
Enrollment:
210
What Is This Study About?
The fornix is a structure in the brain involved in memory and is one of the first areas affected by Alzheimer's disease. This phase 3 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 study, the targeted region is the fornix. Participants will be randomly assigned to receive either an active DBS device or an inactive (placebo) device implanted in the brain. Researchers will measure cognitive function at the start of the study and 12 months after surgery.
Do I Qualify To Participate in This Study?
Must have:
- 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) or confirmation of Alzheimer's disease based on CSF biomarkers
- 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, or a previously documented intolerance/failure to cholinesterase inhibitor medications, with no change in dose during the trial
Must NOT have:
- 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 two 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 two 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 positron emission tomography 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 one year
- Enrolled in another clinical trial
Need Help?
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at
800-438-4380
or
email ADEAR.
Where Is This Study Located?
Source:
ClinicalTrials.gov ID:
NCT03622905