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

This study is currently recruiting participants.
Verified January 2014 by Functional Neuromodulation Ltd
Sponsor:
Information provided by (Responsible Party):
Functional Neuromodulation Ltd
ClinicalTrials.gov Identifier:
NCT01608061
First received: May 21, 2012
Last updated: January 31, 2014
Last verified: January 2014

May 21, 2012
January 31, 2014
May 2012
December 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01608061 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
ADvance DBS-f in Patients With Mild Probable Alzheimer's Disease
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer Disease
  • 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
  • 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
  • Experimental: DBS-f on
    DBS-f on
    Intervention: Device: DBS-f on
  • Sham Comparator: DBS-f off
    DBS-f off
    Intervention: Device: DBS-f off
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2015
December 2014   (final data collection date for primary outcome measure)

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.
Both
45 Years to 85 Years
No
Contact: Kristen Drake (214) 543-8321 kdrake@fxneuromod.com
United States,   Canada
 
NCT01608061
FNMI-001
Yes
Functional Neuromodulation Ltd
Functional Neuromodulation Ltd
Not Provided
Principal Investigator: Andres Lozano, MD, PhD University Health Network, Toronto
Principal Investigator: Constantine G Lyketsos, MD, MHS, DFAPA, FAPM Johns Hopkins University
Functional Neuromodulation Ltd
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP