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 Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
55 Years | 80 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 | City | State | Zip Code | Status | |
|---|---|---|---|---|---|
Geolocation is 33.4636012, -112.0535987 | Site | Phoenix | Arizona | 85006 | Recruiting |
Geolocation is 33.612697, -112.280129 | Site | Sun City | Arizona | 85351 | Recruiting |
Geolocation is 29.647247, -82.4156829 | Site | Gainesville | Florida | 32607 | Recruiting |
Geolocation is 39.2713976, -76.5603828 | Site | Baltimore | Maryland | 21224 | Recruiting |
Geolocation is 39.9583587, -75.1953934 | Site | Philadelphia | Pennsylvania | 19104 | Recruiting |
Geolocation is 41.8396817, -71.3883751 | Site | Providence | Rhode Island | 02906 | Recruiting |
Geolocation is 43.6534023, -79.4053266 | Site | Toronto | Ontario | M5T 2S8 | Recruiting |
Lead Sponsor:
| Agency |
|---|
Functional Neuromodulation Ltd. |
Collaborator Sponsor:
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Andres Lozano, MD, PhD | Principal Investigator | University Health Network, Toronto |
Constantine G. Lyketsos, MD | Principal | Johns Hopkins University |
Study Contact:
| Name | Phone | |
|---|---|---|
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
