Alzheimer's Disease Education and Referral Center

ADvance Deep Brain Stimulation in Patients with Mild Probable Alzheimer's Disease

ADvance Deep Brain Stimulation in Patients with Mild Probable Alzheimer's Disease

Overall Status: 
Recruiting
Brief Description: 

The primary purpose of this study is to evaluate the safety of deep brain stimulation of a brain structure called the fornix (DBS-f) in people with mild Alzheimer's disease. All device- and/or therapy-related adverse events will be assessed.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
45 Years
85 Years
Both
No
Inclusion Criteria: 

  • Probable Alzheimer's disease according to the National Institute of Aging/Alzheimer's Association criteria
  • Must meet certain criteria on cognitive and behavioral rating scales
  • Female subjects must be postmenopausal, surgically sterile, or willing to use birth control for the duration of the study
  • Available caregiver willing to participate
  • Living at home and likely to remain at home for the study duration
  • Taking a stable dose of cholinesterase inhibitor medication for at least 60 days

Exclusion Criteria: 

  • Current major psychiatric disorder such as schizophrenia, bipolar disorder, or major depression
  • History of head trauma in the past 2 years
  • History of brain tumor, subdural hematoma, or other clinically significant space-occupying lesion seen on CT or MRI results
  • Mental retardation
  • Current alcohol or substance abuse
  • Contraindications for MRI or PET scanning (e.g., insulin dependent diabetes, implanted metallic devices, claustrophobia)
  • Abnormal lab results or cardiovascular/neurovascular disorder that would preclude participation in the study
  • Unstable doses of any medication prescribed for the treatment of memory loss or Alzheimer's disease
  • Taking non-Alzheimer's medications that would preclude participation in the study
  • Life expectancy of less than 1 year
  • Actively enrolled in another clinical trial

Detailed Description: 

The primary purpose of this study is to evaluate the safety of DBS-f in people with mild Alzheimer's disease. All device- and/or therapy-related adverse events will be assessed. The secondary objective is to preliminarily estimate the treatment effect size on the outcomes of interest after 12 months. For more information about this study, visit www.advancestudy4ad.com.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 33.4636012, -112.0535987

Banner Alzheimer's Institute
Phoenix
Arizona
85006
Recruiting
Stephanie Reeder
866-840-5838
BAIinfo@bannerhealth.com

Geolocation is 33.612697, -112.280129

Banner Research Institute at Sun City
Sun City
Arizona
85351
Recruiting
Monika Sawdy
623-832-6512
monika.sawdy@bannerhealth.com

Geolocation is 29.647247, -82.4156829

University of Florida at Gainesville
Gainesville
Florida
32607
Recruiting
Stacy Merritt
352-273-5614
stacy.merritt@neurology.ufl.edu

Geolocation is 39.2713976, -76.5603828

Johns Hopkins Bayview
Baltimore
Maryland
21224
Recruiting
Jane Pollutra
410-550-4258
Jpollut1@jhmi.edu

Geolocation is 39.9583587, -75.1953934

Hospital of the University of Pennsylvania: Penn Memory Clinic
Philadelphia
Pennsylvania
19104
Recruiting
Jessica Nunez
215-662-4379
jessica.nunez@uphs.upenn.edu

Geolocation is 41.8396817, -71.3883751

Brown University
Providence
Rhode Island
02906
Recruiting
Diane Monast
401-455-6403
dmonast@butler.org

Geolocation is 43.6534023, -79.4053266

Toronto Western Hospital
Toronto
Ontario
M5T 2S8
Recruiting
Karen Ng
416-603-5800 ext. 3304
Karenwy.ng@uhnresearch.ca
Lead Sponsor: 
Agency
Functional Neuromodulation Ltd.
Collaborator Sponsor: 
Facility Investigators: 
NameRoleAffiliation
Andres Lozano, MD, PhD
Principal Investigator
University Health Network, Toronto
Constantine G. Lyketsos, MD
Principal
Johns Hopkins University
Study Contact: 
NamePhoneEmail
Kristen Drake
(214) 543-8321
Locations
 
 
ClinicalTrials.gov ID 
NCT01608061 (follow link to view full record on ct.gov in new window)
Official Title: 
A Twelve Month Double-blind Randomized Controlled Feasibility Study to Evaluate the Safety, Efficacy and Tolerability of Deep Brain Stimulation of the Fornix (DBS-f) in Patients With Mild Probable Alzheimer's Disease
Study Start Date: 
May 2012
Study End Date: 
December 2014
Disease Stage: 
Early
Enrollment: 
50