ADvance DBS-f in Patients With Mild Probable Alzheimer's Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Functional Neuromodulation Ltd
ClinicalTrials.gov Identifier:
NCT01608061
First received: May 21, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

The primary objective of this feasibility study is to evaluate the safety of DBS-f in patients with mild Alzheimer's disease by assessing all device and/or therapy related adverse events. The secondary objective is to preliminarily estimate the treatment effect size on the outcomes of interest at 12 months post-randomization. The objectives do not involve formal tests of hypotheses.


Condition Intervention Phase
Alzheimer Disease
Device: DBS-f on
Device: DBS-f off
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Functional Neuromodulation Ltd:

Primary Outcome Measures:
  • The study will assess the acute and long-term safety of the system. A detailed assessment of all device and/or therapy related adverse events will be conducted. [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy outcomes include: improvement in ADAS-cog 13 at twelve months, improvement in the CDR and changes in glucose metabolism measured by FDG-PET at twelve months [ Time Frame: twelve months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DBS-f on
DBS-f on
Device: DBS-f on
deep brain stimulation of the fornix
Other Names:
  • DBS-f system includes:
  • *Medtronic Activa PC Model 37601 Implantable Neurostimulator (INS)
  • *Medtronic Model 3387 DBS Lead
  • *Medtronic Model 37085 DBS Extension Kit
  • *Medtronic Model 3708660 DBS Extension Kit
Sham Comparator: DBS-f off
DBS-f off
Device: DBS-f off
deep brain stimulation of the fornix turned off
Other Names:
  • DBS-f system includes:
  • *Medtronic Activa PC Model 37601 Implantable Neurostimulator (INS)
  • *Medtronic Model 3387 DBS Lead
  • *Medtronic Model 37085 DBS Extension Kit
  • *Medtronic Model 3708660 DBS Extension Kit

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 45-85 years of age (inclusive)
  2. Probable Alzheimer's disease according to the National Institute of Aging Alzheimer's disease Association criteria.
  3. Must meet certain criteria on cognitive and behavioral rating scales
  4. If female, subjects who are post-menopausal or surgically sterile or willing to use birth control methods for the duration of the study.
  5. An available caregiver willing to participate.
  6. Subject is living at home and likely to remain at home for the study duration.
  7. The subject is currently taking a stable dose of cholinesterase inhibitor (AChEI) medication for at least 60 days

Exclusion Criteria:

  1. Must meet certain criteria on cognitive and behavioral rating scales
  2. Current major psychiatric disorder such as schizophrenia, bipolar disorder or major depressive disorder based on psychiatric consult at screening visit
  3. History of head trauma in the 2 years prior to signing the consent to participate in the study
  4. History of brain tumor, subdural hematoma, or other clinically significant (in the judgment of the investigator) space-occupying lesion on CT or MRI
  5. Active psychiatric disorder
  6. Mental retardation
  7. Current alcohol or substance abuse as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
  8. Contraindications for PET scanning (e.g., insulin dependent diabetes)
  9. Contraindications for MRI scanning, including implanted metallic devices (e.g. non-MRI-safe cardiac pacemaker or neurostimulator; some artificial joints metal pins; surgical clips; or other implanted metal parts), or claustrophobia or discomfort in confined spaces.
  10. Abnormal lab results that, in the opinion of the investigator and/or enrollment review committee, would preclude participation in the study.
  11. Abnormal cardiovascular or neurovascular disorder that, in the opinion of the investigator and/or enrollment review committee, would preclude participation in the study.
  12. Unstable doses of any medication prescribed for the treatment of memory loss or Alzheimer's disease.
  13. Currently prescribed any non-AD medications that, in the opinion of the investigator and/or enrollment review committee, would preclude participation in the study.
  14. Is unable or unwilling to comply with protocol follow-up requirements.
  15. Has a life expectancy of < 1 year.
  16. Is actively enrolled in another concurrent clinical trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608061

Locations
United States, Arizona
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
Banner Research Institute at Sun City
Sun City, Arizona, United States, 85351
United States, Florida
University of Florida at Gainesville
Gainesville, Florida, United States, 32607
United States, Maryland
Johns Hopkins Bayview
Baltimore, Maryland, United States, 21224
United States, Pennsylvania
Hospital of the University of Pennsylvania: Penn Memory Clinic
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02906
Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
Functional Neuromodulation Ltd
Investigators
Principal Investigator: Andres Lozano, MD, PhD University Health Network, Toronto
Principal Investigator: Constantine G Lyketsos, MD, MHS, DFAPA, FAPM Johns Hopkins University
  More Information

Additional Information:
No publications provided

Responsible Party: Functional Neuromodulation Ltd
ClinicalTrials.gov Identifier: NCT01608061     History of Changes
Other Study ID Numbers: FNMI-001
Study First Received: May 21, 2012
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Functional Neuromodulation Ltd:
Mild probable Alzheimer's Disease

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014